The global market for Highly Potent Active Pharmaceutical Ingredients is currently on a growth fast track, largely driven by its major use in oncology for cancer treatment and more often in the form of ADCs. Over a quarter of drugs worldwide now contain HPAPIs, as they have proven to be more effective than other APIs.
However, working with APIs high in potency and cytotoxicity comes with many regulations and requirements, and presents pharmaceutical companies with challenges such as handling, containment, cost and security questions.
The inaugural Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
Hear about new innovative containment risk assessment tools and containment strategies when handling HPAPI products. Guidance for the evaluation and management of cross-contamination will be addressed, as well as newest control strategies and solutions. Pharmaceutical companies will be presenting their approaches to scale-up processes and will be discussing manufacturing facility designs and requirements, also introducing flexible facilities. Learn more about CMO selection strategies and how to improve information and technology transfer.
This conference will cover many important and in-demand aspects of the HPAPI industry, creating a networking platform for industry professionals and key players to share their knowledge and find innovative new solutions.
- Alessandro Briggo – Principal Scientist, Toxicology Project Leader, Roche
- Alexander Flückiger – Chief Occupational Health Officer, Roche
- Aurore Perzyna – Head, Production Plant, Oril Industries
- Claudia Sehner – Principal Scientist, Occupational Toxicology, Boehringer Ingelheim
- Dean Calhoun – President /CEO, Affygility Solutions
- Eberhard Ramisch – Global Head Projectmanagement Pharmaceutical Ingredients, Heraeus GmbH & Co. KG
- Fabio Zenobi – EHS Director, BSP Pharmaceuticals
- Gregory Sowell – Principal Scientific Manager, Small Molecule Process Chemistry, Genentech
- Gwydion Churchill – Associate Director of Chemistry, Antibiotics Business Unit, AstraZeneca
- Ildiko Ziegler – Distinguished Validation Expert, Gedeon Richter Plc.
- Jack Brown – Senior Principal Scientist, Boehringer Ingelheim Pharmaceuticals, Inc.
- James Evans – Vice President CMC, NuCana BioMed Limited
- Jason Hamm – Director — Chemical Development Operations, Bristol-Myers Squibb
- Jhon Escobar – Operations /Supply Chain Manager, Teva API
- Michael Groaning – Director, Strategic Development, Endocyte
- Richard Denk – Head Sales Containment, SKAN AG
- Robert Sussman – Principal Toxicologist and Managing Principal, Eastern Operations, SafeBridge Consultants LLC
- Shay Carmi – OPEX QC Workstream Leader — Teva Tech Site, Teva API
- Yaakov Machlav – Process Safety Manager, Teva Pharmaceuticals Ltd
- Basic understanding of occupational health risk assessments: hazard and exposure
- Case study 1: steroid hormonal API production
- Case study 2: manufacturing parenteral cytotoxic products
- “Categories of concern” (cytotoxics, hormones, steroids) are often referred to, but rarely defined for APIs requiring segregation or dedication in manufacturing
- Challenges with HPAPIs are very unique, in that there is typically limited data on.
- Characteristics of these categories are discussed to identify and prioritize compounds requiring special attention
- Complexity of cross contamination risk and technical measures at production areas
- Compliance with worker health regulations in an environment where no-one complies
- Containment from the PDE/OEL to Life Cycle
- Containment Risk Management of HP drug substance throught FMECA
- Controlling airborne concentrations and the contamination of product contact surfaces to values derived from quantitative risk assessments is more appropriate, regardless of specific categorical designations
- Criteria for selecting an external vendor for the manufacture of HPAPI’s
- Development of robust process utilizing plant data systems
- Documented containment capabilities: having the data and being able to explain them
- Effectively scaling up potent APIs from clinical to manufacturing scale
- Engineering controls utilized in API plants for HPAPI’s
- Full overview on Containment
- General SHE aspects: no undue risk for the project
- Important to consider to design a Containment Facility
- Industry movement is toward establishing compound-specific health-based limits and performing risk assessments to determine whether segregation and/or dedication may be required
- Misunderstandings and high risk approaches can lead to delays and substantial cost increase
- Outsourcing of novel complex cytotoxic components is challenging
- Outsourcing: a SME Pharma Perspective
- Project-specific tech transfer: competent and responsive partners wanted
- Smart Case studies to avoid obstacles and early pitfalls
- There is typically limited process data as well. How do you understand the processes and their characteristics?
- This would include process safety data (calorimetry, toxicological data for intermediates)
- Toxicological concerns in „cross contamination” guidelines
- Will discuss approaches to both and upside and down sides for each)