Production Systems-Biological Drug Products

This course relates to the manufacturing of biological drug products. It is one of a series of three courses related to the manufacture of drug products. The three options, sterile drug products, non-sterile drug products and biological products are designed to give participants the opportunity to focus on drug products which are relevant to them.

This course is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

We teach you the important formulation requirements for each of this product types and how those requirements influence the performance of the medicine in the body. We also teach you the key processing steps in the production of this dose form, as well as critical quality attributes and critical process parameters. We also cover what can go wrong during the processing of biological drug products and the potential consequences to the safety, quality and efficacy of the medicine.

On completion of this course delegates will know and understand:

• The principles of drug design and formulation and the impact of even minor modifications on bioavailability/bioequivalence.
• The various processes involved in the manufacture of major dosage forms.
• The Good Manufacturing Practice (GMP) issues and challenges to enable informed release decisions.
• How to apply the knowledge to:
  • Risk management
  • Risk assessment
  • Problem solving and decision making
  • Auditing

This biotech course includes:

• The key design, controls and monitors associated with the common biotech process steps
• The basic science and typical process controls associated with producing a high quality biological or biotech drug substance
• An introduction to how quality is assured across the bioprocess and the insights/limitation of QC testing
• A summary of hot topics including regulatory censure, GMP observations and trends
• Guidance on the key concerns when acting as QA/production/technical services professional in this field

We explain the critical requirements of cGMPs alongside a range of bioprocesses, including:

• Seed/cell banking
• Serial and bulk cultivation
• Harvesting
• Centrifugation
• Viral inactivation
• Chromatography
• Ultrafiltration
• Protein concentration

Quality Unit Professionals and Pharmaceutical Technical Professionals

• This course is suitable for professionals working at drug product manufacturing sites and those whose role requires them to understand manufacturing processes, such as auditors, staff with quality oversight responsibilities and regulators.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.

Course tutors will be selected from the following:

• Philip Rose
• Nick Martin
• Chester French