Highly Potent Compounds
Highly Potent Active Pharmaceutical Ingredient (HPAPIs or HPAIs) compounds present many challenges due to the complex handling required for toxic substances. Utilizing cRABs (Closed Restricted Access Barrier System) for commercial manufacturing allows BioPharma Solutions to maintain a high level of containment while a product is being manufactured. In addition, this technology maintains the integrity of the molecule, enhances product sterility and ensures the safety of the line operators.
Dealing with high potency molecules, including antibody-drug conjugates (ADCs), requires a dedicated facility that utilizes experienced operators, sophisticated equipment and systems, and robust standard operating procedures, training and risk assessments.
BioPharma Solutions’ facility in Halle/Westfalen, Germany, is designed with multiple facilities under one roof with different air handling and waste disposal systems, including 100% waste collection. In addition, our Halle and Bielefeld facilities are certified by SafeBridge doing both parenteral drug substance synthesis and parenteral drug product manufacturing and testing.