博客 - It's been over a year since the ICH Q3D guidelines were updated to include cutaneous and transcutaneous limits.
博客 - Senior Scientist and Technical Specialist Ashley Phillips, discusses a recent publication (Single-day protein LC–MS bioanalysis: can next-generation trypsins cut it?)
博客 - Here, we will summarize the eight essential characteristics of LC-MS/MS method validation, then explain why it is important that you work with an experienced contract research organization (CRO) to ensure quality in each of these areas: Accuracy Precision Specificity Quantification Limit Linearity Recovery Matrix Effect Stability
博客 - Addressing ADC Regulatory Challenges by Providing Validated Assays for Multi-Domain Proteins
博客 - Accelerate timelines, lower costs, and ensure quality for your clinical research in Australia. Our advanced scientific infrastructure and world-class experts attract trials from across the globe and meet their needs with the highest standards and efficient regulatory requirements. Explore the extensive benefits of Australia’s clinical research ecosystem >
博客 - In the 2023 Quarter 1 issue of RQA (Research Quality Association) 2023 Q1 Quasar magazine, John Cheshire, our Senior QA Validation Officer discusses why the industry should be adopting risk-based CSV.
博客 - One of the biggest challenges faced by the bioanalytical sector is the lack of a true reference material. As a result, in most assays, an alternative commercially available therapeutic (for example, an enzyme replacement therapy (ERT) product) can be used as a surrogate for the transgene enzyme. This webinar discusses approaches taken in order to monitor the concentration of the expressed transgene product and any associated immunogenicity.
博客 - As a CRO, meeting client expectations can be an ongoing challenge. What can organisations do to make sure their research is as effective and efficient as possible? In the Autumn 2022 issue of European Pharmaceutical Contractor magazine, the leadership team from Alliance Pharma reviews what CRO organisations can do to make sure their research is as effective and efficient as possible while meeting the ongoing challenge of their customer's expectations.
博客 - Bispecifics (Bs) are biopharmaceutical products that bind to two different targets (epitopes). These are mainly two types: IgG-like (antibodies Abs) and non-IgG-like which include Bites (bispecific T-cell engager) and DARTs (Dual-affinity Re-targeting Antibody).
博客 - Adeno-associated viruses (AAV) are small viruses that infect humans and some other primate species. The AAV is transformed from a naturally occurring virus into a delivery mechanism for gene therapy.