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
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.
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
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.
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
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.
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
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
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.
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
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.