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 and biotechnological industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Post-graduate 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).

• 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.

Results

• 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