The Bioanalytical Development Journey

The biopharma industry is continuing to grow, fueled by a constant influx of innovative drug candidates. But bringing these breakthroughs from lab bench to patient requires a crucial partner to support bioanalytical development. This article delves into the intricate world of bioanalytical method development, where scientists decipher the efficacy and potential of each molecule, designing bespoke tests to track its journey through development and production. We explore the challenges faced by emerging companies and established players alike, from outsourcing dilemmas to navigating the intricate steps of qualification and validation.

For many emerging biotech and biopharma companies, the challenge is to take a molecule that has been shown to have biologic activity and develop a process and analytical methods to support the production of preclinical and ultimately clinical material. Identifying only those assays that are necessary at each stage of the project is an important step to minimize both time and cost. A service partner with extensive experience in method development and exposure to many types of protocols is best suited to provide this type of service and to help ensure that the resultant QC assays are robust, fit-for-purpose, and high-performance.

Finding a partner who values transparent, consistent communication is essential to ensure the efficient development of successful analytical methods that are specifically designed to support the client’s goals. Learn how a CDMO with the capability to develop assays to support a wide range of drug substances, from traditional proteins and antibodies to next-generation cell and gene therapy products, can support your journey from discovery to clinical manufacturing with reduced cost and time.