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PCR-based Assay Regulations and Validation

While many PCR assays are developed for research applications there are further considerations for those that are being developed to become diagnostic assays or to be performed in support of: Biologics License Application (BLA), New Drug Application (NDA), Premarket Approval

Unannounced Audits Are Here – Are You and Your Suppliers Ready?

In May 2017, the European Union’s In Vitro Device Regulation (IVDR 2017/746) went into effect, replacing the In Vitro Diagnostic Device Directive (IVDD). The new regulation is more comprehensive than the IVDD and was introduced to reduce inconsistencies in the

Complete Solutions for IVD Chemiluminescent Immunoassay (CLIA/CLEIA) Development

Accelerate your time to market with fit-for-use products which offer the quality, consistency, and documentation necessary for every step of your IVD development and manufacturing needs.

IVD Lateral Flow Assay Development

An IVD lateral flow assay design is based on current patents, eventual manufacturing specifications, and raw material sources.

Risk Mitigation in IVD Manufacturing

Assessment of critical raw material performance, supply and quality is important to minimize risk. Risk must be assessed and mitigated throughout the entire IVD commercialization process.

IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics

Outsourcing for Efficiency - The Need for Increased Manufacturing Capacity

Case Study: Elypta Needed Contract Manufacturing for a Novel Metabolism-Based Liquid Biopsy

Elypta partnered with us to produce the first standardized extraction kit for GAG quantification in bodily fluids for research use. Our contract manufacturing services move Elypta one step closer to meeting growing customer demands for this novel research assay as

Sensitivity Lateral Flow Diagnostic Assays

Steven J. Oldenburg, Ph.D. provides an overview of lateral flow diagnostic assays and discusses the use of ultra-bright reporter particles based on the unique optical properties of gold nanoshells that significantly increase the sensitivity of lateral flow immunoassays.

Supply chain considerations when developing or manufacturing your IVD assay

The recent pandemic has highlighted that strong supply chain management should be a vital consideration for any potential clinical diagnostic CMO partner as the risk of regional and global disruptions are unlikely to disappear.

Quality & Regulatory Trends

The life sciences industry operates in one of the world’s most regulated environments. Today, we are facing increasing regulatory requirements and complexity.

Detergent Properties and Applications

Use detergents more effectively in cell lysis, membrane protein and lipid solubilization, protein crystallization, or Western blotting.

How Suppliers Impact your ISO 13485:2016 Quality Management System

Enhanced ISO 13485 requirements for IVDs must be implemented by the February 28, 2019 deadline.

Accelerating Time to Market Using Custom Lateral Flow Membranes

For this project, ISO-compliant global facilities and network of supply chain partners were used to provide the manufacturer with a wide range of fit-for-use raw materials and unparalleled supply chain security in order to ensure every need was met for

Cell Viability and Proliferation Assays

Cell based assays for cell proliferation (BrdU, MTT, WST1), cell viability and cytotoxicity experiments for applications in cancer, neuroscience and stem cell research.

Webinar: Improving Reproducibility with Biological Buffers

Experts will explore ways to improve reproducibility when using biological buffers.

Gold Nanoparticles: Properties and Applications

Gold (Au) nanoparticles have tunable optical and electronic properties and are used in a number of applications including photovoltaics, sensors, drug delivery & catalysis.

Qualitative multiplex PCR assay for assessing DNA quality from FFPE tissues and other sources of damaged DNA

The assessment of DNA quality is a crucial first step in acquiring meaningful data from formalin-fixed paraffin-embedded (FFPE) tissues, and other sources of damaged DNA. Using intact genomic DNA is key for successful analysis of chromosomal aberrations (e.g. SNP analysis

Fluorescent in situ Hybridization (FISH)

Available Fluorescent in situ hybridization (FISH) procedures, reagents and equipment.

Tips for Optimizing Immunofluorescence Protocols to Get the Best Image

Uses for immunofluorescence (IF)—where an antibody conjugated to a molecule that fluoresces when excited by lasers— include protein localization, confirmation of post-translational modification or activation, and proximity to/complexing with other proteins.

10 Strategic Considerations When Outsourcing Production of In Vitro Diagnostics

The choice of whether to outsource production of an in vitro diagnostic (IVD) or invest and develop in-house capabilities is a foundational business decision. We highlight 10 important benefits of outsourcing and key considerations that should factor into the evaluation

Outsourcing Security - The need to ensure consistency and continuity of supply in IVD Kit Manufacturing

Vetting a Contract Manufacturing Partner for Your Clinical Diagnostics Kit

While the commercialization pathway for IVD devices is complicated, a knowledgeable contract manufacturing partner can save significant time, money, and aggravation by providing design, quality, and regulatory assistance.

IVD Case Study: CRISPR-based Assay from Mammoth Biosciences

A case study describing how Mammoth Biosciences, a diagnostics company utilizing CRISPR gene editing collaborated with MilliporeSigma for manufacturing scale-up expertise and critical raw material supply chain security to ensure a successful launch and long-term success of their novel SARS