Taking place virtually this June, the 10th Annual HPAPI Summit will unite a global community of experts who are involved in the safe, quality and cost-effective development and commercialization of highly potent compounds.
In a previously slow-moving field, recent months have seen huge advances in regulatory guidance, technology, and potent pipelines. Changes to EU Annex 1, much anticipated revision from Health Canada, and the FDA's tightened regulations on mutagenic impurities, have left drug developers and CDMOs facing more pressure to ensure cGMP compliance for HPAPI. This is heightened by the accelerated commercialization of ADCs and anticipated growth of highly potent compounds in emerging pipelines for innovative treatments.
Covering the latest in containment, industrial hygiene, EHS and outsourcing, the HPAPI summit will provide you with a comprehensive guide to ensure safety and compliance in your HPAPI processes. However, it has never been more vital to look beyond purely containment, to explore the whole story of HPAPI development and manufacturing. Hence across 2 steams and 3 workshops, the 2021 meeting will introduce themes such as:
Safe handling in Research and Development and scale up to clinical with case studies from Novartis, Tarveda Therapeutics and Vertex
Green chemistry and environmental impact, lifecycle management and outsourcing with sessions championed by Ipsen, Takeda and Clovis Oncology
Uniting innovative containment with first-class facility design shown by Merck, Novo Nordisk and ILC Dover case studies
Continuous manufacturing, automation and emerging technologies to ensure your HPAPI development and manufacturing is onboard with industry 4.0
In a previously slow-moving field, recent months have seen huge advances in regulatory guidance, technology, and potent pipelines. Changes to EU Annex 1, much anticipated revision from Health Canada, and the FDA's tightened regulations on mutagenic impurities, have left drug developers and CDMOs facing more pressure to ensure cGMP compliance for HPAPI. This is heightened by the accelerated commercialization of ADCs and anticipated growth of highly potent compounds in emerging pipelines for innovative treatments.
Covering the latest in containment, industrial hygiene, EHS and outsourcing, the HPAPI summit will provide you with a comprehensive guide to ensure safety and compliance in your HPAPI processes. However, it has never been more vital to look beyond purely containment, to explore the whole story of HPAPI development and manufacturing. Hence across 2 steams and 3 workshops, the 2021 meeting will introduce themes such as:
Safe handling in Research and Development and scale up to clinical with case studies from Novartis, Tarveda Therapeutics and Vertex
Green chemistry and environmental impact, lifecycle management and outsourcing with sessions championed by Ipsen, Takeda and Clovis Oncology
Uniting innovative containment with first-class facility design shown by Merck, Novo Nordisk and ILC Dover case studies
Continuous manufacturing, automation and emerging technologies to ensure your HPAPI development and manufacturing is onboard with industry 4.0
