HPAPI Handling & Manufacturing Summit 2021

September 29^th – September 30^th 2021

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

Highly potent active pharmaceutical ingredients (HPAPIs) are known as powerful compounds that might help to treat severe and life-threatening conditions and diseases. At the same time, due to their high potency, these compounds have potential risks for the personnel in the production facility. Special precautions need to be taken to ensure the safety of operators and on the other hand high product quality is also required.

At our online meeting industry leaders, occupational toxicologists and containment experts will present the latest insights affecting the HPAPIs handling landscape. We will talk about complex highly potent compound projects focusing on safe and robust potent API processing, development and scale-up of processes, occupational health risks and toxicological assessment, advancements in isolators and facilities to minimize exposure risk, containment strategies and management of cross-contamination risks and more.

Inevitably, safe and efficient HPAPI handling requires a careful evaluation of multiple factors. Explore how pioneering pharma companies are approaching HPAPI development and processing this coming September.

WE WILL BE FOCUSING ON

• classification and handling of hazards, PDE/OEL/HBEL setting in HPAPI environment
• occupational health, exposure monitoring and analysis of industrial hygiene data
• process development, scale up and production of complex highly potent compounds
• developing HPAPI containment strategy, containment verification and monitoring
• latest advancements in isolators and facility designs to minimize the risk of exposure
• highly potent APIs in cleaning validation programs, risk-based cleaning validation
• regulatory & quality framework for contamination control and safe handling of HPAPI
• CMO evaluation and selection, supply chain management in CMO partnerships

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

WHO ATTENDED THE EVENT

● 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