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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.
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
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.
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
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.
Outsourcing Security - The need to ensure consistency and continuity of supply in IVD Kit Manufacturing
Outsourcing Security - The need to ensure consistency and continuity of supply in IVD Kit Manufacturing
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
Detergent Properties and Applications
Use detergents more effectively in cell lysis, membrane protein and lipid solubilization, protein crystallization, or Western blotting.
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.
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.
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.
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.
IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics
IVD Lateral Flow – Sample, Conjugate and Absorbent Pad Basics
Ambient Temperature Stabilization of Genomic DNA in Saliva Samples
Saliva provides an alternative to blood as a biological fluid in diagnostic applications.
Outsourcing for Efficiency - The Need for Increased Manufacturing Capacity
Outsourcing for Efficiency - The Need for Increased Manufacturing Capacity
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.
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
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.
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.
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.
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
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.
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.