by Joseph F. Noferi, Edward R. Arling, and Ralph H. Dillon, Pharmacia GS API Biopharma, global supply, and Daniel E. Worden, Worden Enterprises FDA is no longer complacent, punishing noncompliant companies with puny fines, those small slaps at the financial bottom line. FDA?s thunder now includes multimillion dollar fines, permanent injunctions, and prison sentences for senior executives. Companies that emerge as winners in today?s environment are those that treat compliance and risk management with the same flawless planning and execution that they use for their business plans and their financial investments.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
GMP Validated Next Generation Sequencing Services: Viral Safety Testing & Genetic Characterization
March 26th 2025This brochure will expand on our NGS testing services to biopharmaceutical and biotech companies, including viral contamination testing and genetic characterization of cell lines, bulk harvests, virus seeds, and raw materials used for production of biologics including cell and gene therapy products.
Engage with Industry Leaders on Viral Clearance & Viral Safety at 2025 Summit
March 26th 2025Join on June 3-4 in Cologne, Germany to gain insights from leading regulatory authorities, academics, and industry practitioners who define how biologics, vaccines, and advanced therapeutic medicinal products (ATMPs) are evaluated. Discover the latest technologies, learn best practices, and understand how to design an efficient manufacturing process.