How to successfully manage the HPAPI supply chain
The increase in treatments utilizing potent APIs across the industry and their inherently difficult manufacturing process necessitates a level of manufacturing excellence not seen in previous pharmaceutical products.
Robust handling capability to successfully and safely manufacture oral dosage units is an absolute must. From development to commercial scale manufacture, the big question is whether to have these facilities provided in house or utilizing the experience of an external party with a proven track record in handling products as complex and possibly dangerous as HPAPIs.
Learn about Catalent’s Philosophy for Potent Compound Handling and how it focuses on creating an adaptable operational environment, where versatile containment & control is a key to success. The webinar will focus on the following key potent API Concepts:
• Toxicology and Occupational Health
• Risk Assessment & API classification scheme
• Containment and control strategy
• Adaptability and solutions
Our experience is matched with our commitment to continuous improvement, innovation and investment to ensure success in handling of highly potent APIs. Catalent offers a global network with integrated solutions from optimization through supply. We have 20+ years of high potent handling experience and 80+ years providing drug delivery solutions to our customers.
Catalent is the global leader in development solutions and advanced delivery technologies, providing reliable supply for prescription pharmaceuticals, biologics and consumer health products. With over 300 potent compounds handled, Catalent understands the complexity highly potent APIs bring to the manufacturing environment. We possess the necessary expertise to select the best optimized solutions to address these challenges.
Presented by
Karolina Narczykiewicz,
Environment, Health & Safety Manager
Karolina Narczykiewicz leads Environment, Health & Safety for the Catalent Headquarters in Somerset, NJ. Karolina holds a B Sc. in Industrial Engineering and MBA in Global Management. Karolina has been certified through the Safebridge Boot camp training and is an ISO 14001 Lead Auditor. Previously, Karolina served over 4 years as Sr. Safety Engineer with Johnson & Johnson and 4 years as Corporate EHS Engineer with Sika Corporation. Karolina joined Catalent in 2011 leading and managing within the Global EHS Management System and has breadth of auditing experience across the Catalent network. Her focus in relation to potent API handling in Somerset has been on implementing smart and efficient potent compound strategies to allow for flexibility in potent compound handling and to create an adaptable operational environment, where versatile containment & control is a key to success.
