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.
About Novasep:
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.
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 development / 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?
Target Audience
- R&D Process Chemists,
- Process Engineers,
- Managers/Supervisors (Production/R&D/Industrialization),
- CMC/Outsourcing Managers,
- Quality Assurance / Quality Control Managers,
- SHE Managers,
- Consultants
