IVD manufacturing
Applied Filters:
Applications:IVD manufacturing
Content Type:Technical Article
Showing 1-24 of 24 results
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.
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.
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.
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
IVD Lateral Flow Assay Development
An IVD lateral flow assay design is based on current patents, eventual manufacturing specifications, and raw material sources.
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.
IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics
IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics
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.
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.
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
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
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
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 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
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
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
Detergent Properties and Applications
Use detergents more effectively in cell lysis, membrane protein and lipid solubilization, protein crystallization, or Western blotting.
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
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
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.
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.
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.