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Diagnostic OEM & CMO Services

Your Trusted Clinical Diagnostics Contract Manufacturing Partner

Our quality systems and regulatory expertise combined with a full range of custom and contract manufacturing services provide a global solution for the diagnostics industry with a focus on customer satisfaction. We are proud to partner with the world’s largest diagnostics manufacturers as well as helping new diagnostics companies navigate compliance requirements and launch the products that will transform healthcare. We offer a comprehensive array of services to meet the development and production needs of medical device manufacturers and diagnostic organizations worldwide.


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Key technologies we offer for diagnostic assay OEM and Contract Manufacturing Services

Image 1.Key technologies we offer for diagnostic assay OEM and Contract Manufacturing Services

Key Technologies

We offer extensive expertise in many technologies needed to successfully commercialize medical devices and IVD assays.

Molecular Amplification

  • Oligos, probes, amidites
  • DNA/RNA enzymes
  • Molecular-grade buffers, formulations
  • Nucleic acid purification

Conjugation

  • Large molecules to beads/resins
  • Linkage chemistry
  • Detection reagents

Bio-organic Reagents

  • Detergents
  • Resins
  • Carbohydrates
  • Buffers & solutions
  • Hazardous & regulatory complex materials

Detection Chemistry

  • Chemiluminescence
  • Colorimetric
  • Fluorescence

Antibody Production

  • Monoclonal and polyclonal antibody production
  • Blood typing
  • Infectious diseases
  • Biomarkers

Protein/Enzyme Production

  • Recombinant
  • Plant and animal sourced

Packaging Capabilities

We have extensive manufacturing capabilities with a secure supply-chain and global footprint to give you the reliability, consistency, and flexibility to meet your needs.

  • Sterile filtration
  • Hazardous materials
  • Automated torque and weight checks
  • Environmentally-controlled suites
  • Molecular biology-grade environments

Powder Fill

  • 10 ug to 200 kg+
  • Multiple sealing and capping options
  • Pouching and tableting

Liquid Fill

  • Automated filling capabilities
  • Large batch volume for IVD-grade liquid solutions
  • 10 µl to 20 L fill volumes
  • Large contract lyophilization capacity
  • Environmentally-controlled filling

Formats

  • Glass and plastic bottles
  • Tubes and vials
  • Boxes and Bags
  • Cubitainers™
  • Large Volume Totes
  • Multiwell plates
  • Custom labeling including Barcoding

Custom QC Testing

QC scientist viewing computer screen during analysis of OEM or CMO diagnostic assay

Image 2.QC testing analysis for an OEM or Contract Manufacturing Services for diagnostic assay

We offer key QC assay formats relevant to your needs.

Our analysis capabilities include:

Molecular - qPCR, PCR, western blotting, Southern blotting, electrophoresis, nuclease contamination, bacterial growth, cell component isolation kits (DNA, RNA, protein)

Immunological - ELISA, western blotting, Ouchterlony double diffusion, cell staining, histology, serology

Functional - Plasmid purification, cloning, protein depletion, proximity ligation assays (Duolink®)

Other specialized analyses

  • Endotoxins, hematology, enzymatic activity and contamination, cell culture, tablet testing (hardness, friability, and dissolution)
  • Test method validation for niche QC needs and ability to partner with external testing labs for esoteric tests
  • Functional testing of contract manufactured products on client platform

Commitment to Quality

We are an industry leader for complex manufacturing our quality systems are designed to meet stringent regulatory requirements including:

  • ISO 9001:2015
  • ISO 13485:2016
  • 21 CFR 820
  • 98/79 EC In vitro Diagnostics Directive
  • ISO 14001:2015

Our global footprint includes 21 ISO 13485 manufacturing sites.

world map showing major North American and European and Middle Eastern IVD assay component development and manufacturing sites

Image 3.NA and EMEA manufacturing sites for diagnostic assay components


Experienced Project Management to Secure Success

Our dedicated project managers are scientists who understand the technical, operational, and regulatory challenges of our client’s projects. For each client, we offer:

  • Single Point of Contact for operations and project management
  • Resources to help you navigate industry guidelines and regulations
  • Support through your project life cycle

Steps for Success

Inquiry and Consultation

After receiving your inquiry, you will be contacted by one of our Business Development Specialists.

Acceptance

Project specifications are reviewed internally to determine feasibility and costing. Quote for project sent to you.

Creation of Project Team/Implementation

A cross-functional project team is assembled with expertise specific to project. Small-scale validation batched produced.

Full-Scale Implementation

We manufacture at scale to your specifications with your custom packaging/labeling for regional or global distribution.


OEM & Contract Manufacturing
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