Einladung zum Company Day

Transkript

1 Einladung zum Company Day am IZB Martinsried Donnerstag, 25. April 2013, 9:30 14:30 Uhr Neue Wege für die Entwicklung & Herstellung sicherer Biopharmazeutika New approaches in the development & production of safe Biopharmaceuticals 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, 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.

2 Programm 9:30 Uhr Begrüßung der Gäste Dr. Thomas Heister, 9:40 Uhr Plasmid DNA for the most exacting requirements 10:00 Uhr Novel viral vectors and cellular models for improved target and compound research Dr. Martin Schleef, Dr. Christian Thirion, 10:20 Uhr Kaffeepause / Imbiss: Networking & Diskussion 10:50 Uhr Mass spectrometry and biophysical characterisation services for Biopharmaceuticals 11:10 Uhr Regulatory expectations and scientific methods utilized for the characterization of biologics Dr. Catherine Evans, Dr. Thomas Heister, 11:30 Uhr Kaffeepause / Imbiss: Networking & Diskussion 12:00 Uhr Production of therapeutic proteins, antibodies, and vaccines on a human expression platform Dr. Nicole Faust, CEVEC Pharmaceuticals Gmbh 12:20 Uhr Networking, Diskussion & Fingerfood Die Firmen stehen für Fragen, Gespräche und Diskussionen zur Verfügung 14:30 Uhr Verabschiedung der Gäste

3 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, 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, is SGS s Centre of Excellence for cell bank characterisation & virus testing. Mass spectrometry & biophysical characterisation services for Biopharmaceuticals Dr. Catherine Evans, 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, has performed analyses on the top 30 commercialized biological products, as well as other originator, biosimilar and biobetter products still in development. 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.

4 Company Abstracts 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.

5 Veranstaltungsort Innovations- und Gründerzentrum Biotechnologie (IZB) Matrinsried In den Räumlichkeiten der BioM Veranstalter sind die präsentierenden Firmen Am Klopferspitz 19a Planegg / Martinsried Ansprechpartner Dr. Thomas Heister t thomas.heister@vitrologybiotech.com Dr. Catherine Evans t catherine.evans@sgs.com Dr. Christian Thirion t thirion@sirion-biotech.com Limited CEVEC Pharmaceuticals Dr. Martin Schleef t martin.schleef@plasmidfactory.com CEVEC Pharmaceuticals GmbH Dr. Nicole Faust t faust@cevec.com Wir bitten um Ihre Anmeldung bis zum an folgende - Adresse thirion@sirion-biotech.com oder thomas.heister@sgs.com