To understand industry approaches for developing high-concentration formulations, BioPhorum Development Group Formulation workstream conducted an inter-company collaborative exercise which included several surveys. This collaboration provided an industry perspective, experience, and insight into the practicalities for developing high-concentration biologics.
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This member only survey covers the challenges of working with ultra-high concentration formulations, including; low dose volume products, viscosity aspects related to manufacturing and delivery, manufacturing and filling, automated screening, analytical challenges, osmolality considerations (hyper and hypo), syringeability, acceptable injection forces.
This database and paper provide a comprehensive review and list of potential problematic HCPs that could impact the safety, efficacy, and quality aspects of CHO-produced biologics during their development and manufacturing. They provide a reference on the best practice and control strategy for “high-risk” HCPs” in the biopharmaceutical industry.