ENABLING BIOLOGICS SUPPLY FOR BIOTECH START-UPS

Successful process and product development in biopharmaceuticals relies on several critical factors. The development and manufacturing of protein drug substances require advanced bioprocessing, scalable production, and stringent quality control to ensure efficacy and safety. Aseptic processing, including packaging, is essential to maintain product integrity and comply with regulatory standards.

Robust analytical development, product characterization, and quality control ensure consistency through comprehensive testing and stability studies. Efficient release and distribution to clinical sites demand a well-organized supply chain and adherence to Good Distribution Practices (GDP).

Additionally, regulatory support and specialized CRO/CDMO services help navigate complex approval processes and maintain compliance. Excellence in these areas is key to delivering high-quality biopharmaceuticals to patients efficiently and safely.

Thus, end-to-end supplies of clinical trials represent a challenging task especially for biotech start-ups. This panel of experts consisting of CROs & CDMOs with sites in South Germany and with global reach will discuss solutions to enable timely and cost-competitive clinical supplies and distribution to support biotech start-ups.