Dr Daniel Müller, GMP Inspectorate Tübingen, Germany
Dr Steffen Gross, Paul-Ehrlich-Institut, German Agency for Vaccines and Biomedicines
Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut, German Agency for Vaccines and Biomedicines
Dr Olwen Birch, Lonza, Switzerland
Dr Markus Fido, VelaLabs, Austria
Dr Klaus Hajszan, VelaLabs, Austria
Dr Paul Stockbridge, Biopherma Consulting, UK
Dr. Jochen Probst, IDT Biologika, Germany
Dr Christoph Peter, Apceth, Germany
Peter Rogge, Rentschler Biotechnologie GmbH, Germany
This conference will provide information about the changes in the Annex 2 and the impact of these changes on biopharmaceutical development and manufacturing. Expert speakers from authorities, industry and laboratories with experiences on different types of biopharmaceuticals, e.g. vaccines, gene therapeutics ATMP, will present their experiences on implementation of the Annex 2. They show you the regulatory requirements as well as practical approaches to realize GMP standards in biopharmaceutical development and manufacturing companies. It will be a unique chance to discuss the different points of view with speakers and colleagues.
On 31 January 2013, the new Annex 2 of the EU GMP Guide becomes effective. In the review period of about five years the volume increased from 5 to 32 pages. The revised version shows comprehensive modifications and additions in comparison with the last version. The tremendous developments in the area of biopharmaceutical products - especially the developments in the area of transgenic products and Advanced Therapy Medicinal Products (ATMP) - urgently required a review. The first significant modification already becomes obvious in the name of this Annex. In its 2004 version it only comprised "Biological Medicinal Products", while the new version now also covers "Biological Active Substances".
To take into consideration the diversity of biological products the new Annex 2 is separated in two parts. Part A comprises the general requirements relative issues like Personnel, Premises and Equipment, Starting and Raw Materials, Production and more.
Part B of the revised Annex 2 covers the special requirements with regard to the origin or respectively to the type of product. The following groups are addressed:
Animal sourced products
Allergen products - materials manufactured by extraction from natural sources as well as by recombinant DNA technology
Animal Immunosera products
Monoclonal antibody products
Transgenic animal products
Transgenic plant products
Gene therapy products
Somatic and xenogeneic cell therapy products and tissue engineered products
The new Annex 2 necessitates for many companies and institutes to review their existing quality system to evaluate whether additional measures are necessary.