Coronavirus COVID-19 (SARS-CoV-2) Detection, Characterization, Vaccine and Therapy Production

COVID-19

 Expediting Your COVID-19 Response, Vaccine Research, Therapeutic Development

As a global life science supplier, we are here to help in the response to COVID-19. From supplying raw materials and research products for detection and characterization to production, we’ve consolidated relevant product and service offerings within a single page.

Current events around the spread of COVID-19 and its impact on public health continue to evolve. During this extraordinary time, we are committed to providing researchers, developers and manufacturers with the necessary products and services to aid the COVID-19 response. As such, our top priorities remain the safety and well-being of our employees, meeting the needs of our customers, providing accurate, timely, information, and ensuring business continuity.

We have mobilized a global task force to actively evaluate the overall supply chain of both our products and key raw material suppliers to mitigate any potential disruption. Leveraging business continuity plans, we remain dedicated to supplying our customers in all markets and providing support to the scientific efforts under way around the world, with products and services supporting both the detection of COVID-19 and the development of vaccines and therapies.

This page will be regularly updated with new products and information.
 

 Virus Detection

We are committed to providing researchers with the reagents and technical expertise for timely support of the SARS-CoV-2 outbreak. Explore our offering across viral RNA purification, RT-PCR, RT-qPCR, Immunoassay, and supporting reagents that are suitable for SARS-CoV-2 diagnostics assay development.

See a comprehensive overview of our solutions for Immunoassay and Molecular Dx assay development.

 SARS-CoV-2 qPCR Assay Designs, Primers, Probes, and Controls

Our scientists have created qPCR assay designs for detection of SARS-CoV-2 for open use.  For the designs in the tables below, review our existing SARS-CoV-2 target detection information around assay design and reactivity; primer and probe design; and, genetic analysis.

For research use only.  Not for use in diagnostic procedures.

SARS-CoV-2 qPCR Detection Assays
 

Assay Detection Chemistry Forward Reverse   Probe
1 SYBR Green GCCTCTTCTCGT
TCCTCATCAC
AGCAGCATCACCG
CCATTG
   
2 SYBR Green AGCCTCTTCTCG
TTCCTCATCAC
CCGCCATTGCCAG
CCATTC
   
3 Dual-Labeled Probe CCGCAAGGTTCT
TCTTCGTAAG
TGCTATGTTTAGT
GTTCCAGTTTTC
A AAGGATCAGTGCC
AAGCTCGTCGCC
4 Dual-Labeled Probe GGCTTACCGCAA
GGTTCTTC
TGCTATGTTTAGT
GTTCCAGTTTTC
A AAGGATCAGTGCC
AAGCTCGTCGCC
5 Dual-Labeled Probe CAGGTATATGCG
CTAGTTATCAGAC
CCAAGTGACATAG
TGTAGGCAATG
B AGACTAATTCTCC
TCGGCGGGCACG
6 Dual-Labeled Probe GCAGGTATATGC
GCTAGTTATCAG
ACACTGGTAGAAT
TTCTGTGGTAAC
B AGACTAATTCTCC
TCGGCGGGCACG

For Research Use Only. Not for use in diagnostic procedures.


SARS Positive Control qPCR Assay

 

Assay Detection Chemistry Forward Reverse Probe Probe Sequence
SARS Positive
Control
Dual-Labeled Probe GCTGTGTGTTTGC
CTATGTTGG
ACGTTCACGACTC
AGTATCTCAAG
SARS Control AGCGTGCCTACTG
GGTTCCTCGTGC

For Research Use Only. Not for use in diagnostic procedures.


Predesigned Primers & Probes

Our qPCR assay designs above are available for immediate ordering from our KiCqStart® product lines.
 


Custom Primers & Probes

To request a quote for custom primers and probes, please email dnaoligos@milliporesigma.com.

Custom Positive Controls

The SARS-CoV-2 virus has a positive-sense ssRNA genome. We offer in vitro transcribed ssRNA against regions of this genome, which can serve as positive controls. We can synthesize custom sequences from 150 to 420 nucleotides (to ensure successful manufacturing, please avoid sequences with inverted repeats and repetitions).

To request a quote or additional help, please email sirnarequest@milliporesigma.com.
 

 Molecular Analysis and Supporting Reagents

SARS-CoV-2 positive control

Single stranded RNA (ssRNA) Reference Material intended for the use as a positive quality control sample for coronavirus SARS-CoV-2 in real-time RT-PCR assays.
 

Description Product No.
Single stranded RNA (ssRNA) fragments of SARS-CoV-2
EURM019

For Research Use Only. Not for use in diagnostic procedures.


RT-PCR Analysis

Reagents and tools collected here for viral genetics research include nucleid acid purification (NAP) kits for viral RNA purification, high-efficiency systems for RT-PCR and quantitative RT-PCR, cDNA synthesis kits, and more. One-step kits can simplify and accelerate gene amplification across a wide dynamic range.
 

Description
Product No.
ViralXpress DNA/RNA Extraction Reagent
3095
Guanidine hydrochloride, for molecular biology, ≥99%
G3272
Guanidine hydrochloride, ≥99% (titration)
G4505
Guanidine hydrochloride, BioUltra, for molecular biology, ≥99.5% (AT)
50933
Iron oxide (II,III), nanoparticles, 30 nm, streptavidin functionalized
900148
GenElute™ Total RNA Purification Kit
RNB100

For Research Use Only. Not for use in diagnostic procedures.
 

For Research Use Only. Not for use in diagnostic procedures.

 

 Immunoassays


 Antibodies & Antigens

*New* Antibodies for Viral Antigen Test Development

*New* Mouse monoclonal anti-SARS-CoV-2 nucleocapsid antibody clones tested for use in Lateral Flow Assay and ELISA.
 

Description Product No.
Anti-SARS-CoV-2 Nucleocapsid Antibody, clone 502, 1mg MABX8419-1MG
Anti-SARS-CoV-2 Nucleocapsid Antibody, clone 502, 10mg
MABX8419-10MG
Anti-SARS-CoV-2 Nucleocapsid Antibody, clone 503, 1mg MABX8420-1MG
Anti-SARS-CoV-2 Nucleocapsid Antibody, clone 503, 10mg MABX8420-10MG
Anti-SARS-CoV-2 Nucleocapsid Antibody, clone 504, 1mg MABX8421-1MG
Anti-SARS-CoV-2 Nucleocapsid Antibody, clone 504, 10mg MABX8421-10MG

For Research Use Only. Not for use in diagnostic procedures.


*New* SARS-CoV-2 Antigens

*New* 2019nCoV Nucleocapsid full-length antigens tested for use in Lateral Flow Assay.
 

Description Product No.
2019-nCoV Nucleocapsid Recombinant Antigen, full length (Ag-4) AGX804
2019-nCoV Nucleocapsid Recombinant Antigen, full length (Ag-5) AGX805
2019-nCoV Nucleocapsid Recombinant Antigen, full length (Ag-6) AGX806
2019-nCoV Nucleocapsid Recombinant Antigen, full length (Ag-7) AGX807
2019-nCoV Nucleocapsid Recombinant Antigen, full length (Ag-8) AGX808
2019-nCoV Nucleocapsid Recombinant Antigen, full length (Ag-9) AGX809

For Research Use Only. Not for use in diagnostic procedures.


Antibodies for Serology Assay Development

Antibody product range useful for subclassification of human immunoglobulins (IgM, IgG, IgA) in whole blood for serological assay development. Mouse monoclonal anti-Human IgG and IgM validated for use in Lateral Flow Assay and ELISA.
 

Description Product No.
Mouse Anti-Human IgG, monoclonal, validated for use in Lateral Flow Assay and ELISA
MABX1901
Mouse Anti-Human IgM, monoclonal, validated for use in Lateral Flow Assay and ELISA
MABX1911
Goat Anti-Human IgG Antibody, HRP conjugate AP112P
Goat Anti-Human IgG Antibody, HRP conjugate AP309P
Anti-human IgM (μ-chain-specific) HRP A6907
Anti-human IgA (α-chain-specific) HRP A0295

For Research Use Only. Not for use in diagnostic procedures.

 

 Microspheres & Nanoparticles

*New* Estapor® Europium Fluorescent Microspheres for enhanced quantitative Lateral Flow assay development. Significant improvements in sensitivity due to longer Stokes shift, reduced background noise, and enhanced quantum yield. Carboxylated surface (-COOH) for easy protein conjugation.

We also offer 300-500nm COOH-Fluorescent microspheres, COOH-Dyed microspheres and magnetic microspheres for automated immunoassay platforms.

Estapor® Europium and Fluorescent Microspheres
 

Description Product No.
F1-EU 010 Fluorescent red, diameter (μm): 0.13-0.19, >300 -COOH 80380623
F1-EU 030 Fluorescent red, diameter (μm): 0.27-0.33, 200-500 -COOH 80380624
F1-EU 050 Fluorescent red, diameter (μm): 0.45-0.53, 1-10 -COOH 80380625
F1-XC030, Fluorescent COOH-Microspheres, 300nm
39412085
F1-XC050, Fluorescent COOH-Microspheres, 500nm 39566001

For Research Use Only. Not for use in diagnostic procedures.


Dyed Estapor® Microspheres of 300nm
 

Description Product No.
K1-030, Red COOH-Microspheres, 300nm
80380011
K1-030, Blue COOH-Microspheres, 300nm 39457080
K1-030, Black COOH-Microspheres, 300nm 80380143

For Research Use Only. Not for use in diagnostic procedures.


Estapor® Magnetic Microspheres
 

Description Product No.
EM1-100/40, Magnetic COOH-Microspheres, 1.0µm 23710087

For Research Use Only. Not for use in diagnostic procedures.


Gold Nanoparticles

Gold nanoparticles (20-50 nm) and our gold nanoparticle kits provide an easy way to customize your colorimetric lateral flow test to your antibody of choice. Gold nanoparticles are chemically inert, have a long shelf life, and exhibit exceptional optical properties, making them one of the most widely used choices for Lateral Flow Assays. Download our Bioconjugation Handbook.
 

Description Product No.
Gold nanoparticles, 10 nm, amine functionalized, PEG 5000 coated 765309
Gold nanoparticles, 20 nm, amine functionalized, PEG 5000 coated 765341
Gold nanoparticles, 50 nm 753645
Gold nanoparticles, 20 nm, NHS ester functionalized, conjugation kit 900475
Gold nanoparticles, 50 nm, NHS ester functionalized, conjugation kit 900478
Gold(III) chloride trihydrate 520918

For Research Use Only. Not for use in diagnostic procedures.


Probumin

Diagnostic Grade BSA for protease sensitive immunoassays and as a stabilizing agent for protein reagents requiring low IgG levels; may be used for molecular biology applications. Purity is ≥ 98%; typical purity is 100%.
 

Description Pack Size Product No.
Probumin® Bovine Serum Albumin 1kg 820452
Probumin® Bovine Serum Albumin 5kg 820456
Probumin® Bovine Serum Albumin 100g 820451

For Research Use Only. Not for use in diagnostic procedures.
 

ProClin™ 300

Biocide designed specifically for use within Diagnostics manufacturing applications only. An effective, environmentally-friendly alternative to existing diagnostic reagent preservatives. At recommended usage levels, ProClin™ presents no health hazards, toxicological problems or disposal issues.
 

Description Product No.
ProClin™ 300 48912-U

For Research Use Only. Not for use in diagnostic procedures.

 

 Ultrapure Water

With rapidly evolving and diverse research projects, changing priorities, multiple users and limited space, it’s critical for laboratories to select equipment that is versatile, innovative and flexible to their space requirements. Our Milli-Q® IQ 7000 ultrapure water system and its application filters tick all these boxes.
 

 Key Components for Viral Transport Media

The CDC recently published method for labs to create their own viral transport media. Refer to SOP#: DSR-052-01: Preparation of Viral Transport Media. Specimens can be stored for up to 72 hours at 4℃.
 

 Immunology

Patient immune response to COVID-19 infection is variable and may contribute to negative clinical outcomes. A hyperinflammatory response can lead to cytokine storm syndrome (CSS), with significant impact on disease severity. Cytokine reagents and Milliplex® multiplex cytokine/chemokine detection panels provide comprehensive understanding of the inflammatory response to viral infection for both human and non-human primate samples.

 Human and mouse cytokines for viral response and inflammation research

The immune response to SARS-CoV-2 infection can lead to significant COVID-19 patient morbidity and mortality. Our diverse collection of human and nonhuman cytokines may help to elucidate patient Inflammatory and anti-inflammatory compensation in research models.
 

Description Product No.
IFN-alpha 2b human
recombinant, expressed in E. coli, ≥98% (SDS-PAGE), ≥98% (HPLC)
SRP4595
Interferon β from mouse
≥95%, recombinant, expressed in E. coli, buffered aqueous solution, suitable for cell culture
I9032
Interferon-γ human
IFN-gamma, recombinant, expressed in HEK 293 cells, suitable for cell culture, endotoxin tested
I17001
Interleukin-2 human
IL-2, recombinant, expressed in HEK 293 cells, suitable for cell culture, endotoxin tested
I17002
Interleukin-7 human
≥98% (SDS-PAGE), recombinant, expressed in E. coli, lyophilized powder, suitable for cell culture
I5896
IL-10 human
Animal-component free, recombinant, expressed in E. coli, ≥98% (SDS-PAGE), ≥98% (HPLC)
SRP3312
Granulocyte colony-stimulating factor human
G-CSF, recombinant, expressed in E. coli, suitable for cell culture
G0407
Interferon-γ-Inducible Protein-10 human
≥97% (SDS-PAGE), recombinant, expressed in E. coli, lyophilized powder
I3400
MCP-1/MCAF human
Animal-component free, recombinant, expressed in E. coli, ≥98% (SDS-PAGE), ≥98% (HPLC), suitable for cell culture
SRP3109
Tumor Necrosis Factor-α human
TNF-α, recombinant, expressed in HEK 293 cells, suitable for cell culture
H8916
Interferon Alpha 2A human
recombinant, expressed in HEK 293 cells, ≥98% (SDS-PAGE), lyophilized powder
SRE0013
IFN-alpha 1 human
recombinant, expressed in E. coli, ≥95% (SDS-PAGE), ≥95% (HPLC)
SRP4596
IFN-alpha 2a human
recombinant, expressed in E. coli, ≥95% (SDS-PAGE), ≥95% (HPLC)
SRP4594

 

 Vaccine Production

Effective quality assurance, constant quality control and accurate results are key to manufacturing safe therapies. Our complete solutions for microbial bioburden, sterility and mycoplasma testing as well as environmental monitoring help you meet the highest quality standards and regulatory demands.

 Upstream

Our upstream portfolio includes single-use bioreactors, cell culture media, media supplements, critical raw materials, buffers, mixers and a full range of filtration technologies to prevent microbial contamination and ensure your process meets yield and productivity targets.
 

Description Product No. Process Step
CellPrime® rTrypsin 1.06301.0001 Cell Culture
EX-CELL® MDCK Serum-Free Medium for MDCK Cells 24581C-10L Seed Train
Mobius® Single-Use 3L Bioreactor CR0003L200 Bioreactor
Viresolve Barrier Micro Process Development Kit VBMSPDKNB9 Upstream Virus Filtration
Millipore Express® SHR with prefilter membrane in 25 mm Optiscale® devices SHVEA25NB6 Upstream Sterile Filtration
Millipore Express® SHC membrane in 25 mm Optiscale® devices SHGEA25NB6 Upstream Sterile Filtration
ALiCE Cell-Free Protein Expression Kit
AL0103000
Antigen Generation

 

 Downstream

From scale-up to full-scale production, we offer a range of filtration technologies, buffers, CIP solutions, stainless and single-use systems, integrated technologies as well as validation services. Coupled with our in-house application experts who have decades of know-how, we can help you tackle any downstream processing challenge.
 

Description Product No. Process Step
Millistak+ Pod Depth Filter, CE50 media series, 0.027 m2 surface area, 1/4 in. Hose Barb connection MCE50027H1 Harvest / Clarification
Millistak+ Depth Filter in µPod format, CE50 media series, 23 cm2 surface area, Luer fitting connection MCE5023CL3 Harvest / Clarification
Optiscale Capsule Polysep II 1.0/0.5 µm 1/4 in. HB/HB SGW6A47HH3 Harvest / Clarification
Millistak+ Depth Filter in µPod format, D0HC media series, 23 cm2 surface area, Luer fitting connection MD0HC23CL3 Harvest / Clarification
Millistak+ HC Pod Depth Filter, D0HC media series, 0.027 m2 surface area, 1/4 in. Hose Barb connection MD0HC027H1 Harvest / Clarification
Pellicon XL Filter Module Durapore 0.45 µm 50c m2 PXHVMPC50 Harvest / Clarification
Polysep™ II 1.0/0.2/0.1 µm SGW1A47HH3 Harvest / Clarification
Milligard® 0.2 µm SW03A47HH3 Harvest / Clarification
Milligard® PES 1.2/0.2 µm nominal SMP2A25NB6 Harvest / Clarification
Triton X-100 1.08643.1000 Virus Inactivation
Benzonase® suitable for biopharmaceutical production EMPROVE® bio 1.01697 Nuclease
Benzonase® suitable for biopharmaceutical production EMPROVE® bio 1.01695 Nuclease
Benzonase® ELISA kit II for the immunological detection of Benzonase® 1.01681 Nuclease
Pellicon XL Ultrafiltration Module Biomax 300 kDa 0.005 m2 PXB300C50 Ultrafiltration / Diafiltration
Pellicon® 2 Mini Ultrafiltration Module Biomax-100 C 0.1 m 2 P2B100C01 Ultrafiltration / Diafiltration
Pellicon® 2 Mini Ultrafiltration Module Biomax-300 C 0.1 m 2 P2B300C01 Ultrafiltration / Diafiltration
MiniChrom Column Eshmuno® Q, 5 ml 1.25074.0001 Capture Chromatography
Natrix® Q Recon Mini NXF-01 Capture Chromatography
Natrix® Q Pilot NXF-10 Capture Chromatography
MiniChrom Column Fractogel DEAE (M), 5 ml 1.25079.0001 Polish Chromatography
MiniChrom Column Fractogel TMAE (M), 5 ml 1.25069.0001 Polish Chromatography
Durapore®  0.22 µm membrane in 25 mm Optiscale® devices SVGLA25NB6 Downstream Sterile Filtration
Millipore Express® SHC membrane in 25 mm Optiscale® devices SHGEA25NB6 Downstream Sterile Filtration

 

 Formulation

Our extensive portfolio of process chemicals, excipients and lipids are designed for demanding, time-sensitive applications including vaccine formulation.

We offer innovative lipid-based drug delivery excipients, such as Squalene and Synthetic Cholesterol, with superior characteristics enabling you to simplify and streamline formulation processes. You can also take advantage of our customized lipids manufacturing to create a tailored approach for your API.

To meet the unprecedented demand created by the global development of COVID-19 vaccines, we have increased production capacities and can supply GMP material in quantities ranging from grams to tons.

Many of the process chemicals in our broad portfolio are part of our Emprove® Program, which provides comprehensive regulatory documentation to simplify and accelerate regulatory filings.

 Biosafety Testing Services

We’re here to partner with you. Our testing facilities are operating and we’re actively engaging the biopharma community to prioritize biosafety testing during this health crisis. Just as we did during Zika, SARS, and Ebola outbreaks, we’re here to support vaccine and therapeutic developers and manufacturers to prioritize therapies. Contact our commercial teams to discuss your needs.

Learn more about our BioReliance® Viral Clearance Studies.

Learn more about our BioReliance® Bulk Harvest Lot Release Testing and BioReliance® Comprehensive Lot Release Testing.

Learn more about our BioReliance® Product Characterization Services.

Learn more about our BioReliance® Cell Banking and Biorepository Services.

BioReliance® Vaccine Bulk Harvest Testing

Biosafety testing of vaccine bulk harvest and control cells involves a range of tests to demonstrate freedom from adventitious agents (bulk harvest and control cells) and to confirm identity of the vaccine material (bulk harvest). The choice of tests should be based on a viral safety risk assessment as well as relevant regulations and guidance documents and will typically address the following key areas:

  • Detection and identification of vaccine gene of interest
  • Vaccine virus titre
  • Sterility, Mycoplasma and Mycobacterium
  • Neutralization of vaccine virus for cell and in vivo based adventitious virus tests
  • Adventitious viruses

Tests can be performed using a range of methods, from traditional cultivation and sequencing assays to state-of-the art rapid methods employing novel molecular methods such as Next Generation Sequencing and degenerate PCR. Contact info@bioreliance.com to discuss your needs.
 

 Cell Line Characterization

Learn more about our BioReliance® Cell Line Characterization Services.

Learn more about our BioReliance® Product Characterization Services.

Learn more about our BioReliance® Viral Clearance Studies.

Learn more about our BioReliance® Bulk Harvest Lot Release Testing  and BioReliance® Comprehensive Lot Release Testing.

Learn more about our BioReliance® Next Generation Sequencing (NGS).

Learn more about our BioReliance® Blazar Rapid Molecular Detection Platform.

BioReliance® Vaccine Efficacy Studies

Vaccine efficacy studies are performed to establish the ability of the vaccine to induce a protective response. These should be performed before the first in man clinical studies. These studies normally require immunisation into a suitable model system and demonstrating an immune response using firstly ELISA methods and then demonstrating the immune response is protective by using viral neutralization methods. These methods can then be modified and used as potency release assays for releasing each batch of clinical product, as well as a stability indicating method for stability studies. Contact info@bioreliance.com to discuss your needs.
 

 Quality Control and Environmental Monitoring

Effective quality assurance, constant quality control and accurate results are key to manufacturing safe therapies. Our complete solutions for microbial detection and sterility assurance help you meet the highest quality standards and regulatory demands.

Many organizations are experiencing increased production demands as a result of the COVID-19 pandemic situation. The Milliflex Quantum® is a rapid microbial detection technology that can help reduce routine testing times significantly, providing results in 1/3 the time of traditional microbiology methods. This valuable time savings can be leveraged to facilitate early release of urgently needed supplies to their intended destination (medial, hospitals, labs).
 

Product Type
Milliflex Oasis® Filtration System Microbial Bioburden
Milliflex® Quantum Rapid Detection Microbial Bioburden
Steritest™ NEO Sterility Testing Solutions
Steritest Media and Rinsing Fluids Sterility Testing Solutions
Steritest™ Symbio Pumps Sterility Testing Solutions
PyroMAT™ System
Pyrogen Testing
Active Air Monitoring- MAS-100® Family/RCS® Series Environmental Monitoring
Air Monitoring Media- Contact Plates, HYCON® Agar Strips, M Air T® Cassettes, Settle Plates Environmental Monitoring
Passive Air Monitoring- ICR and LI Settle Plates Environmental Monitoring
Surface & Personnel Monitoring- Contact Plates, HYCON® Contact Slides, ICR Swabs Environmental Monitoring
Settle Plates for Active and Passive Air Monitoring ICR LI
Environmental Monitoring
Microbial Air Samplers MAS for Isolators in the Pharmaceutical Industry
Environmental Monitoring
Microbial Air Samplers for Isolators in the Pharmaceutical Industry
Environmental Monitoring
Contact Plates for Personnel and Surface Monitoring ICR RT Environmental Monitoring
Media Fill Testing in the Pharmaceutical Industry
Environmental Monitoring
Milli-Q® IQ 7000 Water System Ultrapure Water
BioPak® application pak Ultrapure Water
Milliflex Quantum® Standard kit  
Rapid Bioburden Testing
Bovine albumin fraction V 
Raw materials for virus transportation media
Gentamicin solution Raw materials for virus transportation media
Amphotericin B solution
Raw materials for virus transportation media
Veal infusion broth  
Raw materials for virus transportation media

 

 Screening

Screening can directly identify drug targets for treating COVID via anti-virals and also aid in identification of targets within producer cell lines that can then be engineered to more efficiently produce virus/viral particle vaccines at a larger scale. Explore our Functional Genomics CRISPR and RNAi Libraries.

 Development and Manufacturing Services

World-class process development and manufacturing for virus-based therapeutic products. From small scale toxicology and Phase I material to commercial-scale manufacturing and fill finish, our flexible facilities and expert staff are leaders in viral product manufacturing. Learn more about our BioReliance® Viral and Gene Therapy Manufacturing.

With extensive experience in producing customized cell lines for enhancing viral vaccine production, our cell engineering services enable you to produce higher levels of vaccine titer and scalable production cell lines. We will work with the parental cell line of your choice to generate your desired modifications.

 Analytical Methods for Nucleic Acid Vaccine

Nucleic Acid Vaccines - Product and process related impurities

A variety of analytical methods are available to assess product purity. Typically, these will include a combination of orthogonal separation techniques, such as chromatography (RP-HPLC, SEC, IEX) and electrophoresis (CE-SDS). Additional assays can be employed to test for impurities specific to the particular product or process. For example, residual enzymes and DNA in RNA based products. Contact info@bioreliance.com to discuss your needs.
 

 Therapy Production

Effective quality assurance, constant quality control and accurate results are key to manufacturing safe therapies. Our complete solutions for microbial bioburden, sterility and mycoplasma testing as well as environmental monitoring help you meet the highest quality standards and regulatory demands.

 Small Molecule Therapeutics

Classical Pharmaceutical Formulation & Manufacturing

Finding a robust formulation, complying with regulatory requirements, and adhering to quality standards are all top priorities when manufacturing an anti-viral or other small molecule drug.

Based on our expertise in this industry, we understand your challenges in development and manufacturing of small molecule pharmaceuticals and formulation and can support you with products and services. Click here to find out more about our portfolio and access relevant technical resources.

Comprehensive End to End Solutions for Genotoxicity Assessment

BioReliance® offers genetic toxicology services for the detection of toxic, mutagenic, clastogenic and morphological transforming activity in a number of well-characterized test systems. Our scientific staff and state-of-the-art facilities provide the most current and comprehensive genetic toxicology resources available anywhere.

 Analysis of Antivirals and other therapeutic drug candidates

Therapeutic drugs must be tested – from drug development to Quality Control (QC) of the active pharmaceutical ingredient as well as the final formulation. Our offering comprises products for Analysis such as: Standards and Reference Materials, HPLC and UHPLC Columns and accessories, TLC products, GC, Solvents, Buffers and Reagents, Sample preparation, Filtration, Water Purification Solutions  and many more.

Various drugs1 are currently under investigation as to whether they are effective treatment for COVID-19, including Lopinavir, Ritonavir2, Chloroquine3, and Fingolimod4 for which we can offer the CRMs and the primary compendial standards.
 

List of CRMs and the primary compendial standards Product No.
Lopinavir United States Pharmacopeia (USP) Reference Standard 1370101
Lopinavir European Pharmacopoeia (EP) Reference Standard Y0001498
Lopinavir Pharmaceutical Secondary Standard; Certified Reference Material PHR1927
Ritonavir United States Pharmacopeia (USP) Reference Standard 1604803
Ritonavir European Pharmacopoeia (EP) Reference Standard Y0000714
Ritonavir British Pharmacopoeia (BP) Reference Standard BP1210
Ritonavir Pharmaceutical Secondary Standard; Certified Reference Material PHR1734
Chloroquine phosphate United States Pharmacopeia (USP) Reference Standard 1118000
Chloroquine phosphate Pharmaceutical Secondary Standard; Certified Reference Material PHR1258
Fingolimod Hydrochloride United States Pharmacopeia (USP) Reference Standard 1270480
Fingolimod hydrochloride European Pharmacopoeia (EP) Reference Standard Y0002055
Hydroxychloroquine Sulfate analytical standard 90527
Hydroxychloroquine Sulfate British Pharmacopoeia (BP) Reference Standard BP1100
Hydroxychloroquine Sulfate British Pharmacopoeia (BP) Reference Standard BP1101
Hydroxychloroquine Sulfate Pharmaceutical Secondary Standard; Certified Reference Material PHR1782
Hydroxychloroquine Sulfate United States Pharmacopeia (USP) Reference Standard 1327000
Dexamethasone Pharmaceutical Secondary Standard; Certified Reference Material
PHR1526-1G
Dexamethasone United States Pharmacopeia (USP) Reference Standard 1176007
Dexamethasone European Pharmacopoeia (EP) Reference Standard D0700000
Dexamethasone for peak identification European Pharmacopoeia (EP) Reference Standard Y0001593
Dexamethasone for system suitability European Pharmacopoeia (EP) Reference Standard Y0001177
Dexamethasone acetate (Dexamethasone EP Impurity G) Pharmaceutical Secondary Standard; Certified Reference Material PHR1527-1G
Dexamethasone acetate United States Pharmacopeia (USP) Reference Standard 1176506
Dexamethasone acetate European Pharmacopoeia (EP) Reference Standard D0710000
Desoximetasone United States Pharmacopeia (USP) Reference Standard 1173508
Betamethasone (Dexamethasone EP Impurity B) Pharmaceutical Secondary Standard; Certified Reference Material PHR1398-1G
Betamethasone United States Pharmacopeia (USP) Reference Standard 1066009
Betamethasone European Pharmacopoeia (EP) Reference Standard B1000000
Ciclesonide European Pharmacopoeia (EP) Reference Standard Y0001553
Ciclesonide containing impurity A European Pharmacopoeia (EP) Reference Standard Y0001554
Ciclesonide impurity B European Pharmacopoeia (EP) Reference Standard Y0001555
Ciclesonide impurity C European Pharmacopoeia (EP) Reference Standard Y0001556

 

 Plasma-Derived Therapies

Plasma manufacturers are investigating plasma therapies as a treatment for COVID-19. Plasma production processes are highly variable depending on the production platform utilized. Please visit our Plasma Resource Center for information on common challenges in manufacturing plasma-derived therapies and how we can help you overcome them.

Please see our brochure for an overview of the products and services we have to support plasma-derived therapy manufacturing.

Relevant chromatography and TFF products for plasma can be found below.
 

Description Product No.
ESHMUNO P anti-A 1.20094
ESHMUNO P anti-B 1.20095
Fractogel EMD TMAE (M) 1.16881
Fractogel EMD TMAE (S) 1.16887
Fractogel EMD TMAE Hicap (M) 1.10316
Fractogel EMD TMAE Medcap (M) 1.16885
Pellicon 3 Cassettes
 
Viresolve® Pro Solution VPMNVALNB9
Viresolve®  Pro Micro Shield kit VPMSKITNB9
Viresolve®  Pro Micro Shield H kit VPMHKITNB9

 

 Monoclonal Antibodies

mAb CDMO Services: BioReliance® End-to-End Solutions

Your biotech company has discovered a promising molecule with the potential to develop a biologics drug against COVID-19? If you don’t have the in-house resources and capacity, we can develop and manufacture your treatment for you; offering a flexible model for engagement that can include fast-track development and no upfront payment or booking fees. Our adaptive CDMO solutions allow you to more effectively manage project risks and manage uncertainty, guiding you from cell line development and process development to GMP manufacturing.

Explore our end-to-end MaB manufactring portfolio.
 

Products for mAb Manufacturing

From upstream to downstream, single-use or stainless steel, traditional or intensified processing, we have the full portfolio of chemicals, systems, and consumables to help you produce your monoclonal antibody.  

Explore our portfolio for every step of your mAb manufacturing.
 

 Quality Control and Environmental Monitoring

Effective quality assurance, constant quality control and accurate results are key to manufacturing safe therapies. Our complete solutions for microbial detection and sterility assurance help you meet the highest quality standards and regulatory demands.

Many organizations are experiencing increased production demands as a result of the COVID-19 pandemic situation. The Milliflex Quantum® is a rapid microbial detection technology that can help reduce routine testing times significantly, providing results in 1/3 the time of traditional microbiology methods. This valuable time savings can be leveraged to facilitate early release of urgently needed supplies to their intended destination (medial, hospitals, labs).
 

Product Type
Milliflex Oasis® Filtration System Microbial Bioburden
Milliflex® Quantum Rapid Detection Microbial Bioburden
Steritest™ NEO Sterility Testing Solutions
Steritest Media and Rinsing Fluids Sterility Testing Solutions
Steritest™ Symbio Pumps Sterility Testing Solutions
PyroMAT™ System Pyrogen Testing
Active Air Monitoring- MAS-100® Family Environmental Monitoring for Microbiology
Air Monitoring Media- HYCON® Agar Strips, Settle Plates Environmental Monitoring for Microbiology
Passive Air Monitoring- ICR and LI Settle Plates Environmental Monitoring for Microbiology
Surface & Personnel Monitoring- Contact Plates, HYCON® Contact Slides, ICR Swabs Environmental Monitoring for Microbiology
Settle Plates for Active and Passive Air Monitoring ICR LI Environmental Monitoring for Microbiology
Microbial Air Samplers MAS for Isolators in the Pharmaceutical Industry Environmental Monitoring for Microbiology
Microbial Air Samplers for Isolators in the Pharmaceutical Industry Environmental Monitoring for Microbiology
Contact Plates for Personnel and Surface Monitoring ICR RT Environmental Monitoring for Microbiology
Media Fill Testing in the Pharmaceutical Industry Environmental Monitoring
Milli-Q® IQ 7000 Water System
Ultrapure Water
BioPak® application pak Ultrapure Water
Milliflex Quantum® Standard kit  
 
Bovine albumin fraction V 
 
Gentamicin solution  
Amphotericin B solution
 
Veal infusion broth  
 

 

 Biosafety Testing Services

We’re here to partner with you. Our testing facilities are operating and we’re actively engaging the biopharma community to prioritize biosafety testing during this health crisis. Just as we did during Zika, SARS, and Ebola outbreaks, we’re here to support vaccine and therapeutic developers and manufacturers to prioritize therapies.

Learn more about our BioReliance® Cell Line Characterization Services.

Learn more about our BioReliance® Product Characterization Services.

Learn more about our BioReliance® Viral Clearance Studies.

Learn more about our BioReliance® Bulk Harvest Lot Release Testing and BioReliance® Comprehensive Lot Release Testing.

BioReliance® Vaccine Bulk Harvest Testing

Biosafety testing of vaccine bulk harvest and control cells involves a range of tests to demonstrate freedom from adventitious agents (bulk harvest and control cells) and to confirm identity of the vaccine material (bulk harvest). The choice of tests should be based on a viral safety risk assessment as well as relevant regulations and guidance documents and will typically address the following key areas:

  • Detection and identification of vaccine gene of interest
  • Vaccine virus titre
  • Sterility, Mycoplasma and Mycobacterium
  • Neutralization of vaccine virus for cell and in vivo based adventitious virus tests
  • Adventitious viruses

Tests can be performed using a range of methods, from traditional cultivation and sequencing assays to state-of-the art rapid methods employing novel molecular methods such as Next Generation Sequencing and degenerate PCR. Contact info@bioreliance.com to discuss your needs.
 

 Novel Modalities

Nucleic Acid Vaccines - Product and process related impurities

A variety of analytical methods are available to assess product purity. Typically, these will include a combination of orthogonal separation techniques, such as chromatography (RP-HPLC, SEC, IEX) and electrophoresis (CE-SDS). Additional assays can be employed to test for impurities specific to the particular product or process. For example, residual enzymes and DNA in RNA based products. Contact info@bioreliance.com to discuss your needs.
 

 Virus & Viral-Like Therapies

Learn more about BioReliance® Virus Bank Characterization.

Learn more about our BioReliance® Cell Line Characterization Services.

Learn more about our BioReliance® Product Characterization Services.

Learn more about our BioReliance® Viral Clearance Studies.

Learn more about our BioReliance® Bulk Harvest Lot Release Testing and BioReliance® Comprehensive Lot Release Testing.

Learn more about our BioReliance® Cell Banking and Biorepository Services.

BioReliance® Vaccine Bulk Harvest Testing

Biosafety testing of vaccine bulk harvest and control cells involves a range of tests to demonstrate freedom from adventitious agents (bulk harvest and control cells) and to confirm identity of the vaccine material (bulk harvest). The choice of tests should be based on a viral safety risk assessment as well as relevant regulations and guidance documents and will typically address the following key areas:

  • Detection and identification of vaccine gene of interest
  • Vaccine virus titre
  • Sterility, Mycoplasma and Mycobacterium
  • Neutralization of vaccine virus for cell and in vivo based adventitious virus tests
  • Adventitious viruses

Tests can be performed using a range of methods, from traditional cultivation and sequencing assays to state-of-the art rapid methods employing novel molecular methods such as Next Generation Sequencing and degenerate PCR. Contact info@bioreliance.com to discuss your needs.

 ATP Testing & Sanitation

Recent studies of the NIH showed that viable viruses can be detected after 2-3 days. The MVP Icon® is a quick and easy-to-use system to check effectiveness of cleaning and disinfection procedures, even if viruses like SARS-CoV-2 are not directly measured. The MVP ICON® measures the amount of adenosine triphosphate (ATP) in surface samples, an indicator of environmental contamination. Results are obtained in less than a minute and securely documented for subsequent evaluation. The MVP Icon® helps you and your staff in a fast and easy way to monitor the success of cleaning and disinfection procedures.
 

Description
Product No.
MVP Icon® 78300BC
MVP Surface Sampling Device 64003-100

 

 Labware

Our Labware partner brands are chosen to bring our customers the best products from around the industry with easy access and seamless ordering for all of your PCR and RT-PCR needs.
 

Description Product No. Category
Corning® cryogenic vials, external thread, capacity 2.0 mL
CLS430659 Cryogenic Vial
Corning® cryogenic vials, external thread, capacity 5.0 mL
CLS430663 Cryogenic Vial
BRAND® Transferpette® S Pipette, tip volume (0.5-10 μL), single-channel, adjustable volume
BR705870 Pipettes
BRAND® Transferpette® S Pipette, tip volume (0.1-2.5 μL), single-channel, adjustable volume
BR705869 Pipettes
Eppendorf Research® Plus G, 3-pack, 0.5-10 uL/10-100 uL/100-1000 uL, includes epT.I.P.S.® box
EP3123000900 Pipettes
Eppendorf Research® Plus G, 3-pack, 2-20 uL/20-200 uL/100-1000 uL, includes epT.I.P.S.® box
EP3123000918 Pipettes
Corning® 1 x 8 Stripwell™ 96 well plates, high binding surface, flat bottom clear (4 cavity), non-sterile
CLS42592 Plates
Corning® 1 x 8 Stripwell™ 96 well plates, high binding surface, flat bottom white (4 cavity), non-sterile
CLS43923 Plates
BRAND® 96-well PCR plate, semi-skirted, clear, cut corner A1, low profile
BR781374 Plates
BRAND® sealing film for microplates, self-adhesive, suitable for (real-time PCR), polyester
BR781391
Plates
BRAND® 96-well PCR plate, skirted, white, cut corner A12, low profile
BR781378 Plates
Eppendorf® Twin tec PCR plates, 96 wells
EP0030128575 Plates
Eppendorf® ep Dualfilter T.I.P.S.®
EP0030077512 Tips
Eppendorf® ep Dualfilter T.I.P.S.® SealMax
EP0030078721
Tips
Pipette filter tips for Qiagen®
AXYQTF1100CBKRS Tips
PCR strip tubes thin wall, 8 per strip, size 0.2 mL, clear, pkg of 10x125strips/cs
AXYPCR0208C Tubes
PCR strip tube caps for real time PCR, thin wall, size 0.2 mL, pkg of 10x125strips/cs, clear
AXYPCR2CPRTC Tubes
Corning® 15 mL centrifuge tubes polypropylene, conical bottom w/ CentriStar cap, sterile, natural, 500/cs
CLS430791 Tubes
Corning® 15 mL centrifuge tubes polypropylene, conical bottom w/ CentriStar cap, rack packed, sterile, natural, 50/rack, 500/cs
CLS430790 Tubes
BRAND® PCR tubes, strips of 8
BR781316 Tubes
Eppendorf® Safe-Lock micro test tubes, Biopur®
EP0030121589 Tubes
Eppendorf® Safe-Lock microcentrifuge tubes size 1.5 mL, PCR clean pkg of 500
EP022363212 Tubes

 

 Air Monitoring for Chemical Disinfectant Exposures

Applying cleaning agents such as chemical disinfectants and solvents to various work surfaces may release harmful chemical vapors and fumes and expose the employee to an inhalation risk from these hazardous chemicals. While workers wear personal protective equipment (PPE) to protect themselves from an exposure to the virus, it may not be suitable and effective in preventing an inhalation exposure from these chemical cleaning agents. Learn more about our products for disinfectant exposure monitoring by visiting our application page here.
 

Description Product No. Suitability
Coconut Shell Charcoal ORBO Sorbent Tube 20267-U NIOSH 1400 (Alcohols);
OSHA PV2119 (Acetic Acids)
radiello® Passive Sampler for VOCs
RAD130
VOCs, some alcohols
radiello® Passive Sampler for Acetic Acid
RAD166
Acetic Acid
Amberlite XAD®-7 ORBO Sorbent Tube
20053
OSHA 32 (Phenolic Compounds)
radiello® Passive Sampler for Phenolic Compounds
RAD147 Phenolic Compounds
LpDNPH S10 Cartridge
21014
NIOSH 2016 (Carbonyls)
LpDNPH ORBO Sorbent Tube
54020-U NIOSH 2016 (Carbonyls)
DSD-DNPH Passive for Formaldehyde
28221-U OSHA 1007
radiello® Passive Sampler for Aldehydes RAD165 Aldehydes
Silica Gel Sorbent Tube coated w/Sulfuric Acid 20033 NIOSH 6015 (Ammonia) - QAC
Midget Impinger 64712-U OSHA ID-101 (Bleach)

 

 Virus/Host Protein Analysis

Vital tools for analyzing virus and host proteins include the Duolink™ assay, industry-leading reagents for protein separation, and tools for mass spectrometry.

 Protein-protein interaction analysis/PLA

Protein-protein interaction studies have recently been identified as important for SARS-CoV-2 research. The Duolink™ PLA (Proximity Ligation Assay) can be used to confirm endogenous protein-protein interaction in cells and tissues with a microscopy or flow cytometry readout.
 

 Viral and host protein extraction and separation tools

Affinity gels and columns, plus ready-to-use buffer for cell lysis provide rapid extraction of viral proteins on accelerated timelines, with accurate results. Learn how western blot can be used to confirm virus purification.
 

 HPLC/UHPLC and mass spectrometry

Current research related to viruses relies increasingly on protein analysis by (U)HPLC  and mass spectrometry (MS), including MALDI (Matrix Assisted Laser Desorption Ionization). Our complete solutions for UHPLC, HPLC and MS analysis include columns and solvents optimized for these techniques.
 

 RT-PCR Analysis

In addition to being used to aid in the diagnosis of COVID-19, reverse transcriptase–polymerase chain reaction (RT-PCR) is an indispensable technique in the SARS-CoV-2 research lab.

Reagents and tools for viral genetics analysis collected here include nucleic acid purification (NAP) kits for RNA purification, high-efficiency systems for RT-PCR and quantitative RT-PCR, cDNA synthesis kits, and more.

 RT-PCR Tools, Systems and Kits

One-step systems and  PCR master mixes can simplify and accelerate gene amplification across a wide dynamic range. TRI reagent accelerates isolation of nucleic acids and proteins from tissue.
 

 Nucleic acid purification

GenElute™ Total RNA Purification Kits provide a rapid method for the isolation and purification of RNA from a variety of sample types, including viral RNA from cells, tissues, blood, and swabs. These kits are available in miniprep spin columns for efficient, rapid processing.
 

Description Product No.
GenElute™ Total RNA Purification Kit RNB100

 

 Molecular Decontamination and Water Solutions

Protect valuable nucleic acids from loss and degradation with nuclease-free water.
 

 Plates, Tips and Labware for RT-PCR

Our labware tools are chosen to bring our customers the best selection of fit-for-purpose products from across the industry with easy access and seamless ordering for applications critical to viral studies including PCR and RT-PCR.
 

Description Product No. Category
BRAND® Transferpette® S Pipette, tip volume (0.5-10 μL), single-channel, adjustable volume
BR705870 Pipettes
BRAND® Transferpette® S Pipette, tip volume (0.1-2.5 μL), single-channel, adjustable volume
BR705869 Pipettes
Eppendorf Research® Plus G, 3-pack, 0.5-10 uL/10-100 uL/100-1000 uL, includes epT.I.P.S.® box
EP3123000900 Pipettes
Eppendorf Research® Plus G, 3-pack, 2-20 uL/20-200 uL/100-1000 uL, includes epT.I.P.S.® box
EP3123000918 Pipettes
Corning® 1 x 8 Stripwell™ 96 well plates, high binding surface, flat bottom clear (4 cavity), non-sterile
CLS42592 Plates
Corning® 1 x 8 Stripwell™ 96 well plates, high binding surface, flat bottom white (4 cavity), non-sterile
CLS43923 Plates
BRAND® 96-well PCR plate, semi-skirted, clear, cut corner A1, low profile
BR781374 Plates
BRAND® sealing film for microplates, self-adhesive, suitable for (real-time PCR), polyester
BR781391
Plates
BRAND® 96-well PCR plate, skirted, white, cut corner A12, low profile
BR781378 Plates
Eppendorf® Twin tec PCR plates, 96 wells
EP0030128575 Plates
Eppendorf® ep Dualfilter T.I.P.S.®
EP0030077512 Tips
Eppendorf® ep Dualfilter T.I.P.S.® SealMax
EP0030078721
Tips
Pipette filter tips for Qiagen®
AXYQTF1100CBKRS Tips
PCR strip tubes thin wall, 8 per strip, size 0.2 mL, clear, pkg of 10x125strips/cs
AXYPCR0208C Tubes
PCR strip tube caps for real time PCR, thin wall, size 0.2 mL, pkg of 10x125strips/cs, clear
AXYPCR2CPRTC Tubes
Corning® 15 mL centrifuge tubes polypropylene, conical bottom w/ CentriStar cap, sterile, natural, 500/cs
CLS430791 Tubes
Corning® 15 mL centrifuge tubes polypropylene, conical bottom w/ CentriStar cap, rack packed, sterile, natural, 50/rack, 500/cs
CLS430790 Tubes
BRAND® PCR tubes, strips of 8
BR781316 Tubes
Eppendorf® Safe-Lock micro test tubes, Biopur®
EP0030121589 Tubes
Eppendorf® Safe-Lock microcentrifuge tubes size 1.5 mL, PCR clean pkg of 500
EP022363212 Tubes

 Virus Attachment & Entry

When a viral outbreak occurs, determining the mechanism of host cell attachment and entry is a priority. SARS-CoV-2 requires the host ACE-2 receptor and the serine protease TMPRSS2 for entry and spike protein priming, respectively.

 Cell Lines for Virus Propagation and Respiratory Models

Cell lines used to study SARS CoV viral attachment and propagation include Vero variants, Huh-7D, Caco-2, and 16HBE14o-, and are available below.

For additional information, read the technical article on  Cell Lines for Virus Culture and Vaccine Production.
 

 Antibodies and Small Molecules for SARS-CoV-2 and Coronavirus Research

Early research into the cellular entry mechanism has shown that SARS-CoV-2 uses the angiotensin converter enzyme II (ACE2) receptor for attachment and entry, and the serine protease TMPRSS2 for S protein priming. Find monoclonal and polyclonal antibodies and small molecules specific for relevant viruses and the receptors known to be exploited by them for cellular attachment and entry, including ACE2, and explore our groundbreaking Zoomab recombinant antibodies against SARS-CoV-2-related targets.

Read our technical article for more information about SARS-CoV-2 proteins and relevant reagents.
 

 ZooMAb® Recombinant Monoclonal SARS-CoV-1/2 Antibodies

In response to the community’s need for highly specific and reproducible antibodies for SARS-CoV-1/2 research, our scientists have designed ZooMAb® recombinant monoclonal antibodies against various SARS-CoV-1/2 targets. ZooMAb® antibodies are all recombinantly produced, lyophilized, free of animal components, and offer our highest reproducibility to ensure optimal performance now and whenever you need them.

We are committed to providing researchers with the reagents and technical support during the COVID-19 outbreak. Explore our offering of ZooMAb® recombinant monoclonal antibodies that are suitable for COVID-19 research.
 

 Gene Editing

Find reagents here for shRNA or CRISPR approaches for knockdown or knockout of the ACE2 receptor and other genes relevant to SARS-CoV-2, available in plasmid, lentiviral and synthetic formats.

For additional information on viral gene editing, please visit our advanced genomics page.

shRNA ACE2

CRISPR ordering

Explore our Functional Genomics CRISPR and RNAi Libraries to find screening tools to determine which genes make cells more susceptible or resistant to COVID-19 infection, replication, and progression. These tools facilitate research into the development of genetic tests that can be used as secondary diagnostics when assessing predisposition for COVID-19 complications, as well as the risk of infection.