IVD manufacturing

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

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

How to Determine the Best Product & Supplier for Proteinase K

The cost of proteinase K can vary depending on the source, purity, manufacturing process and vendor’s quality management system. It is important to balance the cost with the desired quality, performance, documentation and technical/quality support to select the optimal Proteinase

Guide on How to Use Proteinase K in Different Procedures

Guidelines on use of proteinase K, an enzyme commonly used to degrade proteins, and protect DNA and RNA from degradation in samples.

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.

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.

Fluorescent in situ Hybridization (FISH)

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

IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics

Choosing lateral flow pad materials is critical to the success of the test. Pads comprise the porous matrices that are used for the sample pad, conjugate pad, and absorbent pad.

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.

How Proteinase K Can Be Used in Tissue Samples

The use of Pro K in combination with other reagents, such as detergents and chaotropic agents, can help to disrupt the cell membranes and release DNA from tissue. This is particularly important for downstream applications such as PCR, sequencing, and

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

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.

Lateral Flow Test: Design, Materials & Manufacturing Insights

Explore design, materials, & manufacturing of lateral flow tests. Learn about reproducibility, optimization, & Hi-Flow™ Plus membranes for efficient scale-up.

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.

How Proteinase K Can Be Used in Blood DNA Extraction Applications

In blood DNA extraction, Proteinase K, an enzyme commonly used to degrade proteins, can help break down the cellular and nuclear membranes, releasing DNA from the cells that protect it from degradation and increase purity/yield making it more suitable for

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.

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.

Probumin^® Bovine Serum Albumin (BSA) Powders & Solutions - Frequently Asked Questions

Probumin® BSA is a commonly used bovine serum albumin for buffers, non-specific blocking, protein stabilization and other diagnostic applications. Given the diverse uses of BSA, here are some frequently asked questions and answers about the molecule, formats, methods, and applications.