2nd HPAPI Handling & Manufacturing Summit 2022

September 29^th – September 30^th 2022

VIRTUAL CONFERENCE

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

• hazard classification and management, PDE/OEL/HBEL settings in HPAPI environment
• occupational health, monitoring of exposure and data analysis in industrial hygiene
• high-potency compound process development, scaling up and production
• establishing an HPAPI containment plan, verifying and monitoring containment
• most recent advances in isolators and facility designs to reduce the risk of exposure
• cleaning validation procedures and risk-based cleaning validation in highly potent APIs
• regulatory and quality framework for managing HPAPI in a safe manner
• CMO selection and evaluation, supply chain management in CMO collaborations

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

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

WHO ATTENDED THE EVENT 2021

● A/S Grindeks ● Abdi Ibrahim Global Pharm ● AdhexPharma ● AGC Pharma Chemicals Europe, S.L.U. ● Apotex Inc. ● AstraZeneca ● Aurobindo Pharma Limited ● Bayer AG ● BioDuro-Sundia Corporation ● Biotage GB Ltd ● Biovac ● Boehringer Ingelheim ● Boehringer Ingelheim Pharma GmbH & Co. KG ● Bristol-Myers Squibb ● Cambrex Corporation ● Catalent ● Cipla Ltd. ● Cristália Prod. Quim. e Farm. LTDA ● Custom Pharma Services ● Eurofins Amatsigroup ● FAREVA Mirabel ● Farmabios SPA ● FPS Food and Pharma Systems srl ● Fresenius Kabi ● Gedeon Richter Plc. ● Glatt India Engineering Pvt Ltd ● HPAPI Project Services Limited ● Johnson&Johnson ● Kindeva Drug Delivery ● Labesfal-Laboratórios Almiro S. A. ● Merck KGaA ● MSD Ballydine ● Novo Nordisk ● Nuvisan Pharma Services ● Oakwood Laboratories, LLC. ● Olon S.p.A ● Oncomed Manufacturing a.s. ● Organon Pharma BV ● Pharmascience Inc. ● Pharmascience Inc. ● PharmaZell GmbH ● Polpharma SA ● Quay Pharmaceuticals ● RCPE GmbH ● SafeBridge Europe ● Sai Life Sciences Limited ● Sandoz GmbH ● Saneca Pharmaceuticals a.s. ● Sanofi ● Sanofi Chimie ● Sanofi-Aventis ZRT ● Scale up Solutions ● Siegfried Evionnaz SA ● STADA Arzneimittel AG ● Symeres ● Vanessa Research