2nd HPAPI Handling & Manufacturing Summit 2022

CONFERENCE OVERVIEW

HPAPIs (highly potent active pharmaceutical ingredients) are potent molecules that may aid in the treatment of serious and life-threatening illnesses and disorders. At a certain time, due to their great potency, these compounds pose a risk to the production facility’s staff. On the one hand, special efforts must be taken to ensure operator safety, while on the other hand, great product quality is also necessary.

Industry leaders, occupational toxicologists, and containment experts will share the most recent insights affecting the HPAPIs handling environment at our online meeting. Complex highly potent compound projects will be discussed, with a focus on safe and secure potent API processing, process development and scale-up, occupational health risks and toxicological assessment, advancements in isolators and facilities to reduce exposure risk, containment strategies and cross-contamination risk management, and more.

Ultimately, safe and efficient HPAPI handling demands a thorough assessment of a variety of parameters. Keep an eye out for more advances in HPAPI manufacturing and processing this upcoming September!

WE WILL TALK ABOUT

• Occupational Exposure Bands (OEBS).
• Determining HBEL for HPAPI – a focus on OEL.
• HPAPI, how modeling the exposure can help setting adapted handling requirement.
• Strategic elements within HPAPI projects.
• Unique development of challenges with a natural product derived material.
• Manufacturing of oncological products by a CDMO.
• Integrated approach to technology transfer and scale up.
• Toxicology assessments for HPAPI manufacturing: what constitutes quality in HBEL reports?
• Verification and monitoring of containment performance.
• Science and risk-based cleaning validation using ASTM standards.
• Design & construction of HPAPI labs.
• Integrating EHS into the product development process.
• Are you protecting your workers during HPAPI manufacturing?

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

• HPAPI Manufacturing/ API Manufacturing/ Compounds Manufacturing
• Occupational Toxicology/ Industrial Hygiene / EHS
• Process Engineering/ Process Development/ Process Scale Up
• Containment/ Cross Contamination/ Cleaning Validation
• Cleanroom/ Facility Design/ Isolators
• Risk Management/ Quality Assurance/ Quality Control
• Analytical Development/ Analytical Methods
• CMO/ CDMO/ Outsourcing

[Agenda] 2nd Annual HPAPI Handling & Manufacturing Summit 2022

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Webinar: Chasing the Nanogram Limit

Flyer: Simplify Your Synthesis with ADCore™ Payload Intermediates

White Paper: Use of Payload Core Compounds to Accelerate ADC Clinical Development Timelines

Flyer: Highly Potent and Complex API Contract Manufacturing in Madison/Verona