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Seminar 3: Particulars of specific product classes: monoclonal antibodies, vaccines, ATMPs and blood products


Course Description

CONTENT

Essentials of the development of monoclonal antibodies – case study

o Milestones and typical pitfalls in the development of mAbs

Registration of vaccines

o Overview on the product class
o Underlying immunology of the mode of action and clinical efficacy of vaccines
o Current and new adjuvants
o Manufacture and quality control requirements
o Special characteristics of the pre-clinical and clinical development of vaccines
o Pre- and post-authorisation documentation requirements for pandemic vaccines

Case study: Approval of HPV vaccines in the EU

Overview on ATMPs

o Regulation and relevant procedures
o Successfully authorised and failed products
o Case studies illustrating the particulars of ATMP development and registration

Registration of blood products

o Manufacturing methods and quality control approach
o Requirements for the selection of the starting material
o Pre-clinical and clinical data requirements
o Certification scheme on Plasma Master File (PMF)

Four unique product classes are introduced with respect to their regulation, the essential requirements for their development, their unique characteristics. Blood products stand for classical biologicals as they are manufactured from a biological source, i.e. human plasma. Their use is still required for many life-threatening and chronic diseases despite the progress recombinant technology made. Vaccines are mostly recombinant proteins and an increasing number of newly developed products is available which are all of special importance for the health systems. Both, blood products and vaccines, require special considerations in their manufacture, selection of starting material, testing and characterization and clinical development. The product class of monoclonal antibodies delivers an increasing number of novel medicines. Their development requires understanding of their special issues such as manufacturing technology options, species specificity for non-clinical development, pleiotropy, limitations of dose-finding approaches etc. Advanced therapy medicinal products are also unique as they are based on gene therapy, somatic cell or tissue engineering approaches. For these products the conventional requirements for biopharmaceuticals often do not apply as they are developed and manufactured for individual patients.

The development process of a biopharmaceutical has principle features in common with conventional drugs but is special in various aspects since their protein nature requires specific considerations. The four featured product classes illustrate how the current regulatory system ensures that a holistic approach of interaction between the manufacturing/testing, non-clinical and clinical team is followed during development.

LEARNING OBJECTIVES

- Get an detailed introduction into the product classes of monoclonal antibodies (mAbs), blood products, vaccines and ATMPs
- Understand why mAbs, blood products, vaccines and ATMPS require a particular development programme
- Understand the underlying principle of the Plasma Master File
- Learn the specific requirements applicable for vaccines
- Get an insight into a special case of a vaccine presented by a regulatory and a company representative
- Learn the specific regulation of ATMPs and the practical requirements for development

AGENDA

Day 1: Wednesday, 03 December 2014

09.15 - 09.30 Welcome and introduction (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

09.30 - 10.30 The product class of blood products (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

The special nature determines the quality, pre-clinical and clinical requirements
Certification scheme on Plasma Master File (PMF)

10.30 - 11.00 Coffee break

11.00 - 12.00 continued (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

12.00 - 13.00 Lunch

13.00 - 15.00 Overview on ATMPs (Zaklina Buljovcic, PharmaLex)

Regulation and relevant procedures
Successfully authorised and failed products

15.00 - 15.30 Coffee break

15.30 - 17.30 Case studies to illustrate the challenges in the development of ATMPs (Zaklina Buljovcic, PharmaLex)

Quality data
Pre-clinical data
Clinical data

17.30 End of Day 1

For Full Course students:

17.30 - 17.45 Introduction to the homework (Gabriele Dallmann, EUCRAF and Biopharma Excellence)

Day 2: Thursday, 04 December 2014

08.30 - 10.30 Vaccines (Jens Vollmar, GSK)

History of vaccine development and currently approved products
Vaccination impact and challenges for new developments
Underlying immunology of the mode of action and clinical efficacy of vaccines
Continuing evolution of vaccine antigens
The role of adjuvants in current and new vaccines
Special characteristics of clinical development of vaccines

10.30 - 11.00 Coffee break

11.00 - 13.00 continued (Jens Vollmar, GSK)

13.00 - 14.00 Lunch

14.00 - 15.30 The product class of monoclonal antibodies (mAb) (Josefine Holz, LEO Pharma and Bioneer-Consulting)

Technologies used to express mAb
Principle quality requirements
Outsourcing and partnering
Clinical development

15.30 - 16.00 Coffee break

16.00 - 18.00 continued (Josefine Holz, LEO Pharma and Bioneer-Consulting)

18.00 End of Day 2

19.00 Get-together with food and wine

Day 3: Friday, 05 December 2014

08.30 - 10.30 Registration of vaccines (Michael Pfleiderer, Paul-Ehrlich-Institut (PEI))

Manufacture and quality control requirements
Pre-clinical package
Benefit/Risk assessment
Pre- and post-authorisation requirements for pandemic vaccines
Special case: Ebola

10.30 - 11.00 Coffee break

11.00 - 12.30 continued (Michael Pfleiderer, Paul-Ehrlich-Institut (PEI))

12.30 - 13.30 Lunch

13.30 – 15.30 Cervarix as an example for successful authorisation of a HPV vaccine (Michael Pfleiderer, PEI & Jens Vollmar, GSK)

Introduction
Regulatory history
Clinical development - primary authorization and life cycle of the clinical indication
Success factors

15.30 - 16.00 Coffee break

16.00 - 17.30 Continued (Michael Pfleiderer, PEI & Jens Vollmar, GSK)

17.30 End of Seminar 3

Entry Requirements

English language knowledge

Course Fees

2.100 EUR regular fee, 1.320 EUR for academic institutions/government (+19% German VAT)


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Recipient: European Centre of Regulatory Affairs, EUCRAF

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