Qepler | summits & conferences | 3rd Annual Highly Potent APIs Summit, 22-24 February 2023, VIRTUAL
Event Location:
Online Conference
Platform:
HOPIN
Date:
22 February 2023 - 24 February 2023
Language:
English
Contact Person: Evgenia Makar
Contact Person: Evgenia Makar, Qepler s.r.o.
Contact Person: Denis Polikarpov
Contact Person: Denis Polikarpov, Qepler s.r.o.

Conference Overview

The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges. Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies.

The featured talks on:

  • HPAPI Process Design and Project Implementation
  • Manufacturing of Oncological Products by a CDMO
  • Garment selection criteria for the safe handling of HPAPI
  • HPAPI manufacturing in early Chemical Development
  • How to handle HPAPIs within Chemical Development
  • What are some hidden risks associated with isolators?
  • Case Study: How to develop a high potent Antibody Drug Conjugate ADC production suite
  • A Systematic Approach to the Safe Handling of Potent Active Pharmaceutical Ingredients
  • Looking Beyond Pharma 4.0: Future Initiatives and Advanced Manufacturing Approaches
  • Sources of cross-contamination risk in solid dosage form manufacturing
  • Cleaning validation – Enhanced approach required for Highly Potent APIs?
  • EHS Integration in Capital Projects and Tech Transfer
  • Integrating EHS into the RFP Process for HPAPIs
  • Quantitative Measurement of Risk in Cleaning using ASTM Standards
  • Occupational Hygiene Programs and Practice Standards of Care
  • The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs)
  • Exposure Assessment Challenges for New Modality Potent Compounds in R&D
  • Flexible Isolator- Occupational Hygiene Experience
  • Occupational Exposure Bands (OEBs)
  • Health-based exposure limits (HBELs) for biotechnological products
  • How to derive health-based exposure limits (HBEL) for ADCs
  • HBEL - containment and occupational hygiene monitoring
  • Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient biopharmaceutical drugs.
  • Ensuring product & worker safety in multi-product GMP facilities.
  • Continuous Processing as a Tool for HPAPI Development and Manufacturing
  • Design Considerations for the Buildout of a New Small Molecule HPAPI R&D Laboratory

Meet our Speakers

Our Partners

PRESENTER
Swiss based company specialized on design and supply of jet mills (spiral and opposite type) and isolators for containment or aseptic use.
Schedio SA

Schedio White Papers:

PREVIOUS EVENT

SNAPSHOT OF ATTENDEES 2020

AbbVie - Acino Pharma AG - Affygility Solutions, LLC - Allergan plc - AMRI ITALY SRL - Andreas Flueckiger Consulting - Angelini Pharma S.p.A. - Bayer AG - Boehringer Ingelheim Pharma GmbH & Co. KG - F. Hoffmann-La Roche AG - Ferring International Center SA - Ferring Pharmaceuticals - Fresenius Kabi Austria GmbH - FUJIFILM Diosynth - GEA Process Engineering nv - Gedeon Richter Plc. - Hebeler Process Solutions LLC - Heraeus Deutschland GmbH & Co. KG - HPAPI Project Services Limited - ILC Dover - Lonza Pharma & Biotech - Merck & Cie - Merck Group - Merck Healthcare KGaA - Merck Performance Materials KGaA - Minakem High Potent - oncomed manufacturing a.s. - Pfizer CentreOne - Pharmacare Premium - Praevena AG - Quinta-Analytica - Raybow Pharmaceutical - SafeBridge Europe, Ltd. - Seqens R&D SERVICES - Servier - Synthon - Takeda - University of Oxford - Vanessa Research Magyarország Kft. - Vetter Pharma-Fertigung GmbH & Co. KG - Zentiva k.s. - Zhejiang Juli Electric Tools Co., Ltd and others.

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