Using LBA, LC-MS and HRAMS Assay Formats Biomarker validation is a valuable tool in drug development support. Whether through discovery, analytical validation or clinical validation, these tests can be used for diagnosis, monitoring, prediction, response measurement, prognosis, safety or risk assessment. As the routine application of biomarkers in the drug discovery process has grown, it […]
FDA Expectations Regarding Immunogenicity Testing Starting with insulin development in the 1920s, therapeutic proteins have evolved quickly in modern medicine. Most of these biologics elicit a specific immune response, Anti-Drug Antibodies (ADA), that are clinically benign. However, some individuals can be adversely affected. For this reason, therapeutic protein products must undergo immunogenicity testing using assays […]
Medical Device Approvals with the National Medical Products Administration (NMPA) In China, medical device manufacturers must have products approved by the National Medical Products Administration (NMPA), the equivalent of the FDA in the U.S. The process can be complex, expensive, and often frustrating at times. Until now. There are three steps for medical device attestation […]
Why the alignment of audit scope with the correct industry standard is important Pharmaceutical supply chains are typically vast and complex, often covering multiple geographical regions and involving a diverse set of suppliers, service providers and subcontractors. To maintain a constant focus on quality across the supply chain network, it is common practice for a […]