Biopharmaceuticals are the next generation of medicines. As they originate from live cells, there are several quality concerns and significant technical challenges during development, manufacturing and testing. This module provides participants with a solid understanding of the production of biopharmaceuticals, and critical aspects to understand during development.
Previously organized by PAO Farmacie, now by PCS Academy.
Professionals in pharmaceutical, biotechnological and medical device industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.
The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs who are dealing with complex quality systems. The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization. The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).
What is it about?
This three-day training provides insight into the development of biopharmaceuticals and how this relates to quality aspects. We will consider the critical steps of developing cell lines, upstream and downstream processes, and commercial manufacturing up to protein analysis. Stability, comparability, contamination and immunogenicity will be discussed, as they require special attention compared to API's of non-biological origin.
Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry, academia and national regulatory authorities will share their wealth of experience and knowledge during the course.
The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.
After having followed this course, you will be able to:
- Understand how biopharmaceuticals are produced and what the differences are between small and large (biopharmaceutical) molecules, including the key process units for cell line development, upstream and downstream processing and how they impact product quality.
- Apply critical process parameters (CPP) and critical quality attributes (CQA) for biopharmaceuticals to achieve a robust process.
- Understand how relevant test methods are best applied and what their limitations are.
- Understand the up-to-date information on relevant ICH guidelines and have the knowledge where to find EMA and FDA guidance for biopharmaceuticals;
- Apply the knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations.
After having followed this course, you will have:
- The knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations, including awareness of how process changes and small differences may impact quality and safety, including immunogenicity.
- Fundamental tools to achieve a robust manufacturing process and insight into how CPP’s and CQA’s are established using different approaches.
- Up-to-date information on relevant ICH guidelines and knowledge where to find EMA and FDA guidance for biopharmaceuticals.
- Introduction to biotechnology
- Upstream process development for biopharmaceutical products
- Cell line development and cell bank preparation
- Purification survey of unit operations and process integration
- Design of an industrial process for purification of biologicals
- Development, tech transfer and commercial production of monoclonal antibodies by cell culture
- Pathogen safety
- Protein analytics of biopharmaceuticals
- Critical attributes and comparability studies
- Quality challenges for Advanced Therapy Medicinal Products (ATMP)
- Biosimilars: a new class of licensed biotech products
- Immunogenicity and formulation of biopharmaceuticals
Go to Quality Management in Pharma and Biotech for more information about the modules.
Date 15-17 November 2021
Location Hotel van der Valk, Breukelen
Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
The fee includes course notes, hotel accommodation, drinks, lunches and dinners. In the event of cancellation, we refer to the general terms and conditions of PCS (www.pcs-nl.com).
Drs. A.C.A.J. (Aad) van de Leur – Byondis B.V.
Aad van de Leur is working at Byondis BV (formerly Synthon Biopharmaceuticals BV). In his present function of COO he is responsible for all Biopharmaceutical operational activities including process development activities from cell line to Drug Product development and related analytical development as well as manufacturing and supply of IMPs with a focus on monoclonal Antibodies and Antibody Drug Conjugates (ADCs).
Before starting at Byondis, he worked for over 23 years at different Biotechnology departments at Diosynth and Organon/Schering-Plough including Cell Culture and Purification Development, Manufacturing and Project Management.