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IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics
IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics
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.
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.
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...
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.
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.
IVD Lateral Flow Assay Development
An IVD lateral flow assay design is based on current patents, eventual manufacturing specifications, and raw material sources.
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...
Ambient temperature stabilization of genomic DNA in Saliva samples
Saliva provides an alternative to blood as a biological fluid in diagnostic applications.
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.
Detergent Properties and Applications
Use detergents more effectively in cell lysis, membrane protein and lipid solubilization, protein crystallization, or Western blotting.
Webinar: Improving Reproducibility with Biological Buffers
Experts will explore ways to improve reproducibility when using biological buffers.
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...
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...
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.
Fluorescent in situ Hybridization (FISH)
Available Fluorescent in situ hybridization (FISH) procedures, reagents and equipment.
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.
ISO 13485 vs. ISO 9001
Misunderstandings about International Organization for Standardization (ISO) management standard 13485, and how it compares to other industry standards such as ISO 9001 or Current Good Manufacturing Practice (cGMP), are common.
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.