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Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are a class of pharmaceutical compounds that are characterized by their high potency and low dosing requirements. These compounds are typically used in the treatment of serious illnesses such as cancer, autoimmune diseases, and viral infections. HPAPIs are classified based on their potency levels, with the most potent compounds being classified as Occupational Exposure Limit (OEL) 4 or 5, meaning they require special handling precautions to ensure worker safety.
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HPAPIs are produced through a complex and specialized manufacturing process that requires stringent quality control measures to ensure their safety and efficacy. The manufacturing process typically involves the use of advanced technologies such as containment systems, isolators, and air handling units to minimize the risk of exposure to the active ingredients. The facilities used for HPAPI manufacturing are designed to meet strict regulatory guidelines, including those set by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Due to their high potency, HPAPIs are associated with a range of health and safety risks for workers involved in their manufacturing, handling, and administration. These risks include skin sensitization, respiratory irritation, and potential long-term health effects such as cancer. To mitigate these risks, strict safety protocols are required for the handling and administration of HPAPIs, including the use of personal protective equipment (PPE) such as gloves, respiratory protection, and full-body suits.
Our Service:
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ALL Chemistry Inc. provides Custom Highly Potent APIs Services that can be used in a wide range of applications, including drug development, clinical trials, and commercial manufacturing. And we understand the engineering controls, toxicity and potency evaluations, and containment strategies of HPAPI production. Our services can be tailored to meet the specific needs of a research project or application. These customizations include: the potency level, the synthesis route, the formulation, and the packaging and labeling. The use of our custom HPAPIs can improve the safety, efficacy, and cost-effectiveness of drug development and manufacturing.
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Service Highlights:
✔ Small Molecule Oncology Products
✔ Linker and Payload for Antibody Drug Conjugates (ADCs)
✔ Batch Size up to 1 kg
✔ Expansion capability to larger scale with up to 50 L jacketed reactors
✔ Reactors up to 22 L for multi-step synthesis
✔ Contianment isolators with safe change HEPA filters
✔ Built in Tray Dryer
✔ Laminar Flow Hoods and vented balance enclosures
+1 609 531 0668
info@all-chemistry.com
STE 104 Marlton , NJ 08053, USA