Safe HPAPI manufacturing: Thinking outside the glovebox!
Sponsored by: Novasep
Date: 1 July
Days to go: 18
Time: 3PM London/4PM CET
Demand for Highly Potent Active Pharmaceutical Ingredients (HPAPIs) is growing strongly, driven by a strong clinical pipeline in the oncology field.
Due to their high pharmacological activity, the development and manufacturing of HPAPIs requires specialized high containment facilities operated by experienced personnel, a strong HSE culture and regulatory expertise, to ensure the safety of both patients and employees.
By nature, HPAPIs are often complex molecules needing special care and specialized technologies for multi-step synthesis and purification. The recent development of antibody-drug conjugates (ADCs) has created new challenges for HPAPI manufacturers.
In this webinar, we will speak about the factors to consider for safe Highly Potent API handling, from development to scale-up and manufacturing, through some case studies based on our extensive experience in the ADC field (payloads and bioconjugation).
Why should you attend this webinar?
In this webinar, you will learn more about risk-based approach throughout HPAPIs manufacturing to ensure occupational safety and to deliver safe product for the patients.
Novasep provides flexible contract development & manufacturing (CDMO) solutions for Small Molecule APIs and biomolecules to innovators. With around 1,100 employees, Novasep is established in Europe, Asia and North America and is constantly expanding its presence to better serve its customers.
We are a world leader in a number of technologies including HPAPIs, ADCs, industrial chromatography (batch and continuous), hazardous & cryogenic chemistry.
The webinar will last around 1 hour. The session will take place at the following time:
- 3 pm BST (London)
- 4 pm CET (Paris)
- 10 am ET (New York)
- 7 am PT (San Francisco)
After registering, you will receive a confirmation email containing information about joining the webinar. If you are unable to attend at this time, please register anyway, and we will send you a link to the recording afterwards.
Rachel De Luca ,
Site Director, Novasep Le Mans, France
Rachel De Luca studied Chemical Engineering at the Imperial College of London and the Ecole Nationale Supérieure des Industries Chimiques (ENSIC) in France where she graduated in 1992. She has more than 25 years of experience in the equipment supply and the CDMO services for the pharmaceutical industry. After working for the INRS (French reference body for occupational risk prevention), she joined Novasep in 2001. She currently heads Novasep Le Mans site, specialized in the process development and manufacturing of HPAPIs, & more recently, bioconjugation.
Ph.D., PR&D group head, Novasep Le Mans, France
Bertrand Cottineau received his Ph.D. degree in organic chemistry at Orleans University in 2002. He has more than 15 years’ experience in process development for API and contributed to 9 scientific publications in international journals. He joined Novasep Le Mans in 2013 to lead the HPAPI process development group and is now responsible for both HPAPI and bioconjugation process development groups.
Key Learning Objectives
- What are the risk related to HPAPI production and when can they occur?
- What Information is required to assess the risks?
- How to reduce the risks at each stage: during the develoment / manufacturing?
- How can process design contribute to safer handling of HPAPIs?
- How does facility design contribute to safer handling of HPAPIs?
- Why is it not sufficient?
- How to ensure risk control over time?
- R&D Process Chemists
- Process Engineers
- Managers/Supervisors (Production/R&D/Industrialization)
- CMC/Outsourcing Managers
- Quality Assurance / Quality Control Managers
- SHE Managers