IVD manufacturing

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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

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.

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.

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

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.

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.

Tips for Immunofluorescence Protocols

Immunofluorescence uses antibody-conjugated fluorescent molecules for protein localization, modification confirmation, and protein complex visualization.

Supply Chain Considerations for IVD Assay

Pandemic underscores importance of strong supply chain management for clinical diagnostic CMO partnerships.

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.

Best Product & Supplier for Proteinase K

Balancing Proteinase K cost with quality and technical support ensures optimal enzyme selection for diverse applications.

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.

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.

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.

Proteinase K in Tissue Samples

Pro K aids in disrupting cell membranes for DNA release, crucial for downstream molecular biology techniques.

Multiplex PCR Assay for Damaged DNA

Quality DNA crucial for meaningful data; intact DNA key for successful chromosomal aberration analysis from FFPE tissues.

Diagnostic Assays Using Leading-Edge Technologies

Discuss challenges and strategies for IVD assay development, commercialization, and utilizing contract manufacturing partners for emerging technologies.

Elypta's Contract Manufacturing Case Study

Elypta partners with us for standardized GAG quantification kits, meeting growing research assay demands along the regulatory path.

Vet Contract Mfg Partner for Clinical Diagnostics Kit

Contract manufacturing aids IVD device commercialization, providing design, quality, and regulatory assistance for smoother processes.

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