Biopharmaceuticals – Quality Development and Documentation

Course content

The aim of this course is to give attendees knowledge about the scientific background of biotechnological products and the regulatory requirements to fulfil, in order to obtain approval of these types of medicinal products.

Attendees will get an understanding of the quality issues specific to biopharmaceuticals, for example; the generation of a recombinant microorganism, the expression of the product from the microorganisms and its purification, and the regulatory expectations for characterisation of a biopharmaceutical product and to release/stability specifications set for these types of products. As process changes are inevitable during development of a biological/biotechnological product this course will provide the implications of changes in the production process and elaborate on the concept of comparability.

In addition to providing the students with a general understanding of specific quality issues for biopharmaceuticals, this course will focus on how to prepare regulatory CMC/Quality strategies and how to ensure compliance with regulatory requirements throughout the clinical development and post-approval processes. The discussions on CMC/Quality strategies will include both EU and FDA aspects, and the lectures will focus attention on both EU and FDA regulatory procedures for approval of biopharmaceuticals. Further, the course will guide the students through the structure of CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

Education

This course is offered in collaboration between University of Copenhagen and Atrium as part of the Master of Medicines Regulatory Affairs.

 

See course calender for course dates

 

This course is compulsory at both the 2016-curriculum and the 2018-curriculum.

The course is also open for single course student.

Learning outcome

After completing the course the student is expected to be able to:

Knowledge

  • Explain the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product

  • Explain and discuss specific quality issues of biopharmaceuticals, product characterization and jusitfy settings in the specifications.

  • Explain and discuss the critical parts of CMC/Quality sections of the submission file.

  • Explain and discuss the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development for approval of biopharmaceuticals and for demonstration of comparability during life cycle management.

Skills

  • Evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval.

  • Create and evaluate a regulatory CMC/Quality strategy for the quality development of biopharmaceuticals, considering both FDA and EMA aspects throughout the clinical development.

  • Evaluate and discuss relevant regulations and guidelines for biopharmaceuticals.

  • Explain and discuss how quality build into daily routines may improve performance and result in faster submission and approval of biopharmaceuticals

Competencies

  • Take action in ensuring that qualified quality descisions are made throughout the development of the biopharmaceutical

  • Apply best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes

Lectures and group work on case stories as well as self-study of course literature.

The syllabus comprises selected EU, USA and ICH legislation and guidelines. A list of reading material will be distributed electronically approx. 4 weeks before the course. The course participants are expected to study parts of the syllabus before the course, especially the ICH Q4M: M4Q Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - Module 2: Quality Overall Summary, Module 3: Quality. In total corresponding to approximately 1400 pages.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English

Oral
Collective
Continuous feedback during the course of the semester
ECTS
4 ECTS
Type of assessment
Course participation, 3 hours
3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To achieve the grade passed the student shall (in an adequate level) be able to:

Knowledge

  • Explain the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product

  • Explain and discuss specific quality issues of biopharmaceuticals, product characterization and jusitfy settings in the specifications.

  • Explain and discuss the critical parts of CMC/Quality sections of the submission file.

  • Explain and discuss the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development for approval of biopharmaceuticals and for demonstration of comparability during life cycle management.

Skills

  • Evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval.

  • Create and evaluate a regulatory CMC/Quality strategy for the quality development of biopharmaceuticals, considering both FDA and EMA aspects throughout the clinical development.

  • Evaluate and discuss relevant regulations and guidelines for biopharmaceuticals.

  • Explain and discuss how quality build into daily routines may improve performance and result in faster submission and approval of biopharmaceuticals

Competencies

  • Take action in ensuring that qualified quality descisions are made throughout the development of the biopharmaceutical

  • Apply best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes

 

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 60
  • Lectures
  • 22
  • Theory exercises
  • 5
  • Exam
  • 3
  • Exam Preparation
  • 20
  • English
  • 110