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FDA Just Changed Clinical Trial Requirements for Biosimilars: How to Leverage Bioanalysis for Successful SubmissionsDiscover how the FDA's new guidelines for biosimilar development eliminate the need for clinical efficacy studies, emphasizing bioanalytical, pharmacokinetic, and immunogenicity data. Learn how to adapt your strategy and leverage high-quality analytics to achieve successful submissions and fast-track development.
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AAV Potency Assays in Preclinical CMC: Key to Successful Gene Therapy DevelopmentLearn why early AAV potency assay development is key to smooth tech transfer, regulatory success, and phase-appropriate CMC strategies in gene therapy.
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4 Pillars of a Robust Pharmaceutical Quality System (PQS)Discover the 4 pillars of a robust Pharmaceutical Quality System (PQS) that ensures drug quality and regulatory compliance. Learn how implementing quality-driven processes, maintaining a clean and safe environment, fostering communication and transparency, and ensuring consistent quality across platforms help meet Health Canada and U.S. FDA standards for drug development.
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Spotlight on Immunogenicity: Neutralizing Antibody Assays (Part II)Understand Neutralizing Antibody (NAb) assays, their importance in immunogenicity testing, and how outsourcing these services can address development challenges.
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Spotlight on Immunogenicity: Anti-Drug Antibody Assays (Part I)Learn about Anti-Drug Antibody (ADA) assays, their role in immunogenicity, and how outsourcing these tests accelerates drug development.
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The Role of Bioanalytical Testing: From Formulation to PatientDiscover the vital role of bioanalytical testing in drug development, from formulation to market approval. Learn how bioanalytical methods ensure safety, efficacy, and regulatory compliance at every stage, including preclinical testing, clinical trials, and post-market surveillance.
