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Highly Potent Active Pharmaceutical Ingredient (HPAPIs or HPAIs) compounds present many challenges due to the complex handling required for toxic substances. Utilizing RABS (Restricted Access Barrier System) for commercial manufacturing helps BioPharma Solutions to maintain a high level of containment while a product is being manufactured. In addition, this technology helps to maintain the integrity of the molecule, enhance product sterility and ensure 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, has multiple manufacturing areas with independent air supply 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.
See "Cytotoxics" for additional information.
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