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Biochemical Engineering

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Bioprocess Validation and Quality Control

Course Code
BENGG026
Level MSc
Credits 15 credits
Module Tutor
Professor Mike Hoare and Dr C Nweke
Assessment

Two 2000 word project reports:

1) an individual validation master plan plus flow sheets (30%),

2) an individual validation master plan plus flow sheets plus equipment layout spec preceded by Moodle Quiz on background reading (70%).

Both reports to include Executive Summary, Description of flow, CQA and CPP impact analysis, validation tasks and scheduling of operations to effect change, Risk analysis.

Prerequisites Courses and projects in design/experimentation in downstream processing (eg BENGG005, BENGM001) and bioreactor design ( eg BENGG001, BENGM002); these operations form the main basis for the validation studies and coursework. Courses in downstream processing and bioreactor design; these operations form the main basis for the validation studies and coursework.

Aims

The course addresses the challenge of the safe delivery to patients of biopharmaceuticals and in particular injectables. The aim of the course is to familiarise students with current validation methodology using leading edge developments with expert speakers in a workshop format. Particular focus is given to development of concepts of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and Quality by Design (QbD).

Following completion of this course, students will:

  • have gained skills to assess new process concepts and judge key issues to be addressed before regulatory acceptability for Manufacture will be achievable.
  • be able to determine the information required and validate a process and the resource requested to manage the implementation of stage leading to full validated status.
  • be able to communicate with validation specialists
  • be aware of what is required by the regulatory authorities for compliance including future direction of the regulations
  • understand the implications of validation for process development
  • be aware of current validation practice across the bioprocess industry
  • have developed written presentation skills on issues of validation including a validation master plan.

Learning Outcomes

Following completion of the course, students will:

  • have gained skills to assess new process concepts and judge key issues to be addressed before regulatory acceptability for Manufacture will be achievable (i.e address codes of practical relating to SHE issues).
  • be able to determine the information required and validate a process and the resource requested to manage the implementation of stage leading to full validated status.
  • be able to communicate with validation specialists
  • be aware of what is required by the regulatory authorities for compliance including future direction of the regulations
  • understand the implications of validation for process development
  • be aware of current validation practice across the bioprocess industry
  • have developed oral and written presentation skills on issues of validation including a validation master plan.

Learning Hours

Includes:

Industrial Expert Lectures: 18h
Seminars and Presentations: 50h

Syllabus

Regulations (FDA and EMEA) to meet product safety for biologics; analytical methods to support process validation; fermentor and control system validation; validation of recovery and purification operations; cleaning, sterilisation and turnaround systems; operation and control of multiproduct plants; change control in the event of process failures /planned enhancements.

Issues assessed include:

  • appraisal of multiproduct facilities and change control
  • validation of process change – scale up and scale out
  • disposable versus conventional equipment – validation appraisal