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  4. (PVT9024) Process Validation for Biopharmaceuticals, and Validation of Aseptic Pharmaceuticals

Module Overview

Process Validation for Biopharmaceuticals, and Validation of Aseptic Pharmaceuticals

  1. This module is a comprehensive overview of a process validation program for a bulk protein therapeutic derived from a biopharmaceutical/biotechnological manufacturing operation. 

    1. The module also provides students with an understanding of the design, operation and validation of the processes and facilities used in the manufacture of aseptic pharmaceuticals, and of the formulation requirements for fill/finish injectable drug products

Module Code

PVT9024

ECTS Credits

10

*Curricular information is subject to change

  1. Drug Substance Process Validation 

    • Biopharmaceutical process unit operations 

    • Process validation workflow, and process validation prerequisites 

    • Cryopreservation storage of cell banks, and cell line characterisation 

    • Clearance studies: nucleic acids clearance, host cell proteins clearance, pyrogens clearance, and viruses clearance 

    • Process validation studies: viral clearance, impurity clearance, process consistency, process intermediate stability, process solution stability, drug substance fill/freeze/thaw/storage, mixing studies and chromatography resin and reusable membrane lifetime validation 

    • Viral safety evaluation of products derived from human or animal cells, and positioning of virus reduction methodologies 

    1. Laboratory/pilot-scale practical, or research case-study 

    1. Laboratory/pilot-scale practical, or research case-study, for upstream processing: inoculum preparation, media preparation, bioreactor preparation, cell culture and harvesting. 

    1. Laboratory/pilot-scale practical, or research case-study, for downstream processing: chromatography column packing, protein separation and purification, ultrafiltration and diafiltration, and final bulk filling. 

     

    1. Technical Review of Regulatory Requirements 

    • FDA Guidance on Aseptic Processing 

    • EU GMP Annex-1: Manufacture of Sterile Medicinal Products 

    • EU GMP Annex-2: Manufacture of Biological Medicinal Products for Human Use 

    • Current regulatory guidance on good manufacturing practices specific to advanced therapy medicinal products (ATMPs). 

     

    1. Facility and Equipment Arrangements for Aseptic Processing 

    • Vial components – liquid filled and freeze-dried vaccines and therapeutics, and vial inspection methods 

    • Process equipment and facility arrangements for aseptic filling 

    • Environmental monitoring program, and media fill program 

    • Validation of aseptic processing, filtration and sterilization 

     

    1. Formulation Development for Fill/Finish Aseptic Products 

    • Setting formulation goals: physicochemical and biological properties 

    • Container closure systems and delivery systems for the administration of parenteral medication to patients 

    • Formulation additives, adjuvants and preservatives 

     

    1. Manufacture of advanced therapy medicinal products (ATMPs) 

    • Allogenic (manufactured in large batches from unrelated donor tissues) and autologous products (personalised medicine: manufactured as a single lot from the patient being treated). 

    • Cell and gene therapies 

    • Challenges to growth of global ATMP sectors 

Lectures, Case Study, Discussion board, Webinars

Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)100