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Well Characterized Biologics & Biological Assays

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November 1-3, 2022
College Park Marriott Hotel & Conference CenterHyattsville, Maryland, USA

Intertek

Profile

For nearly 30 years we have helped the world’s most innovative pharmaceutical and biopharmaceutical companies to navigate the challenges of new product development, drug delivery, production, and market release. We provide a broad range of cGMP, GLP, GCP laboratory services, across many product types such as proteins, mAb, bispecifics, peptides, vaccines, oligonucleotides, mRNA and more. At Intertek, we apply our experience, industry, and regulatory knowledge to design phase specific analytical development programs, tailored to your needs throughout the product lifecycle. We focus on monitoring relevant critical quality attributes (CQAs), to evaluate the impact of process changes on physicochemical properties and structure according to ICH Q6B. We determine product related impurities or process-related impurities and conduct stability studies. We also help you to demonstrate consistency or comparability of manufactured batches and conduct release tests for clinical trial materials or ongoing production