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Neue Wege für die Entwicklung & Herstellung sicherer Biopharmazeutika
Donnerstag, 25. April 2013, 9:30 – 14:30 Uhr

Der Entwicklungsweg vom Molekül bis hin zum fertigen biopharmazeutischen Produkt auf dem Markt ist begleitet von einer Vielzahl verschiedenster wissenschaftlicher, technischer sowie behördlicher Herausforderungen. Um diesen Weg erfolgreich zu durchlaufen, werden spezielle Expertisen und ein breites Spektrum an geeigneten Serviceleistungen in jeder einzelnen Phase benötigt.

DNA, virale Vektoren, zellbasierte Assays, Zelllinien Entwicklung, GMP Produktion, Biosimilars, FDA, ICH, EMA, Biosicherheit, Analyse & Qualitätskontrolle sind Schlagwörter, die, jedes für sich genommen, eine immense Bedeutung in dem komplexen Erzeugungsprozess eines biopharmazeutischen Produkts einnehmen.

PlasmidFactory, Sirion Biotech, CEVEC Pharmaceuticals, SGS M-Scan und SGS Vitrology bieten Ihnen unabhängig voneinander für die verschiedenen Entwicklungsphasen individuelle Lösungen an. Jedes einzelne Unternehmen verfügt über die erforderliche Expertise und Erfahrung in seinem Fachbereich mit einem breiten Leistungsspektrum und kann somit auch Ihre Projekte erfolgreich unterstützen.

Wir freuen uns, Ihnen in einer gemeinsamen Veranstaltung unsere jeweiligen Kernkompetenzen auf einen Blick präsentieren zu können und begrüßen Sie gerne zu unserem „Company Day“ am IZB.

Wir bitten um Ihre Anmeldung bis zum 22.04.2013 an folgende E-Mail-Adresse
thirion@sirion-biotech.com oder thomas.heister@sgs.com

Programm

Company Abstracts

Novel viral vectors and cellular models for improved target & compound research

Dr. Christian Thirion,
SIRION Biotech GmbH

Requirements for cell based assays have induced a rapid development of novel cell models in the past years. To improve the effectiveness of target research and compound development the use of patient derived cell models is gaining importance. SIRION Biotech specializes in viral vector technology and provides sophisticated cell modeling. The combination of unique RNAi technology and expertise in cell culture makes SIRION Biotech a technology leader in the field of functional gene analysis. Moreover, SIRION Biotech has developed viral vectors which serve as the basis for novel future vaccines.

Regulatory expectations and scientific methods utilized for the characterization of biologics

Dr. Thomas Heister,
SGS Vitrology

Biologics and vaccines manufacturers need to perform a range of biosafety tests in order to satisfy regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) in order to demonstrate that drug products are free from any contaminants. These tests include cell bank and virus seeds characterization, raw material and bulk harvest testing (sterility, Mycoplasma, viruses), and final product testing for residual DNA. At SGS Vitrology, our scientific staff and management team have over 20 year experience in the biosafety testing sector and substantial experience and knowledge of worldwide regulatory guidelines (FDA / USP / EMA / Ph. Eur. / ICH) required for testing biological products. Based in Glasgow, Scotland, SGS Vitrology is SGS’s Centre of Excellence for cell bank characterisation & virus testing.

Mass spectrometry & biophysical characterisation services for Biopharmaceuticals

Dr. Catherine Evans,
SGS M-Scan

SGS M-Scan is a leading biopharmaceutical mass spectrometry and biophysical characterisation service provider with over 30 years of industry and regulatory experience. Our labs in Germany, Switzerland, the UK and the US provide GLP / GMP compliant analyses for biopharmaceuticals, from small molecules / new molecular entities and peptides through to proteins and glycoproteins, such as monoclonal antibodies. To date, SGS M-Scan has performed analyses on the top 30 commercialized biological products, as well as other originator, biosimilar and biobetter products still in development. SGS M-Scan has extensive experience in applying its analytical expertise at all stages of the product lifecycle from cell line selection, process verification, pharmacokinetic and metabolism studies, through to final product characterisation.

Plasmid DNA for the most exacting requirements

Dr. Martin Schleef,
PlasmidFactory

PlasmidFactory is Europe‘s leading contract manufacturer of plasmid and minicircle DNA. The company produces clients’ plasmids or minicircles according to their requirements (incl. GMP use) in modern laboratories with high standards.

Plasmid DNA of the highest available quality, ‚High Quality Grade‘, is produced on - site in accordance with the EMEA guideline CHMP / BWP / 2458 / 03. To ensure product safety, substances of animal origin are not used at any stage of this entire process. Furthermore, maximum product purity is assured by reliable exclusion of contaminants such as bacterial chromosomal DNA or damaged plasmid forms. ‚High Quality Grade‘ plasmid DNA is produced based on PlasmidFactory‘s research cell bank (RCB) and the very effective, patented ccc Grade DNA technology. Amongst other applications, such plasmid DNA is successfully used in the GMP-compliant production of recombinant viruses, antibodies and RNA for clinical trials. We will present how in 2013 DNA is produced for use as an ancillary product (“Hilfsstoff”) for GMP manufacturing of active pharmaceutical ingredients, API (“Wirkstoffe”).

Production of therapeutic proteins, antibodies, and vaccines on a human expression platform

Dr. Nicole Faust,
CEVEC Pharmaceuticals GmbH

CEVEC is a global solution provider for the production of biopharmaceuticals and vaccines using their unique cell expression systems. The human CAP and CAP-T cell lines are designed for stable and transient production of biopharmaceutical proteins and viruses / vaccines. They allow for high yield production of recombinant proteins, with excellent biologic activity and therapeutic efficacy, as a result of authentic posttranslational modification. The use of both cell lines throughout the course of biopharmaceutical drug development from early discovery to bioproduction provides the unique advantage of retaining identical protein structures throughout the development process, not having the need to switch production cell lines during development.

Veranstaltungsort

Innovations- und Gründerzentrum
Biotechnologie (IZB) Martinsried

In den Räumlichkeiten der BioM

Am Klopferspitz 19a
82152 Planegg / Martinsried

Ansprechpartner

SGS Vitrology
Dr. Thomas Heister
t +49 170 589 6034
E-Mail

SGS M-Scan
Dr. Catherine Evans
t +41 79 734 03 44
E-Mail

Sirion Biotech GmbH
Dr. Christian Thirion
t +49 89 700 961 99 15
E-Mail

PlasmidFactory GmbH & Co. KG
Dr. Martin Schleef
t +49 521 299 735 0
E-Mail

CEVEC Pharmaceuticals GmbH
Dr. Nicole Faust
t + 49 221 46 02 08 19
E-Mail