Bio Screening Industry News

Laupheim, Germany, Mai 21, 2008 - Rentschler Biotechnologie and Boehringer Ingelheim, both leading companies in biopharmaceutical development and production, have signed a preferred partnership agreement. The cooperation will enable Rentschler Biotechnologie’s clients to gain access to Boehringer Ingelheim’s large-scale mammalian biopharmaceutical production facilities in Biberach, Germany and vice versa, Boehringer Ingelheim’s clients to use Rentschler’s facilities of process development and intermediate-scale clinical supply production.

Through the cooperation clients from the pharmaceutical and the biotech industry will benefit from the combined development and manufacturing know-how and facilities, leading to increased flexibility and ultimately more customized services. Compatible bioprocessing methods guarantee a seamless project transfer between the companies which are conveniently located in close vicinity.

Rentschler Biotechnologie, a full-service contract manufacturer focused on process development and small to medium scale production of mammalian cell-derived biopharmaceuticals, currently operates eight independent GMP lines with fermenter volumes of up to 500 L. A 2,500 L has recently been qualified and is going to start operations. Boehringer Ingelheim, who offers similar services with technologies optimized for large scale industrial production, runs one of the world’s largest biotech facilities with fermenter volumes of up to 15,000 L.

“The cooperation with Boehringer Ingelheim will increase the value of our services, as both  companies will benefit from the combined expertise and the easy transfer from small/medium to large scale production” commented Dr. Wieland W. Wolf, Vice Chairman of the Rentschler Group.

Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President of the Corporate Division Biopharmaceuticals,  Boehringer Ingelheim GmbH said  “Rentschler Biotechnologie is a strong partner for process development and supply of clinical material in Europe and complements our worldwide strategic Production Alliance Network. Based on compatible process technologies and Boehringer Ingelheims proprietary know-how and expertise in high titer and high yield manufacturing process formats we will combine state-of-the-art development at Rentschler for accelerated time to clinic with a smooth technology transfer to Boehringer Ingelheim for large-scale commercial manufacturing”.

Link to the press release:
http://www.b3c.de/php/popup.php?id=103

About Rentschler Biotechnologie – www.rentschler.de

Rentschler Biotechnologie GmbH is part of the privately held Rentschler Group based in Laupheim, Germany. As an international full-service contract manufacturer with a highly skilled staff of 340, Rentschler Biotechnologie has substantial experience in the development, production and approval of cell culture-derived biopharmaceuticals in compliance with international GMP standards. Regulatory advice and fill & finish are part of the company’s service range. As a pioneer in the development and production of biopharmaceuticals, Rentschler was the first company world-wide to gain market authorization for an interferon-containing drug. In 2006, Rentschler announced an investment program of €50 million for expansion of production systems. Currently the first 2,500-L GMP fermentation line is being commissioned.

About Boehringer Ingelheim - www.boehringer-ingelheim.com/biopharm

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing innovative products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of almost 11 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Boehringer Ingelheim is one of the leading companies for industrial customer manufacturing of Biopharmaceuticals by offering the entire production technology chain in development and production at its biopharmaceutical facilities in Biberach (Germany) and in Vienna (Austria). The large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody fragments and plasmid DNA. The Biberach site is specialized in highly efficient mammalian cell culture systems with yields well above industry standard in animal component free media. The Austria site offers high-expression in bacteria and yeast with exceptionally high productivities using proprietary systems. In the plasmid DNA manufacturing arena Boehringer Ingelheim in Austria has set the standard and supplies early to late-stage clinical trials with gene-therapeutics and DNA vaccines for its international clients. For more information see: http://www.boehringer-ingelheim.com/biopharm

Rentschler Biotechnologie gibt  Zusammenarbeit mit Boehringer Ingelheim bekannt

Laupheim, 21. Mai 2008 – Rentschler Biotechnologie und Boehringer Ingelheim, beides  führende Unternehmen im Bereich der biopharmazeutischen Entwicklung und Herstellung, haben eine „preferred partnership“-Vereinbarung unterschrieben. Durch die Zusammenarbeit erhalten Kunden von Rentschler Biotechnologie Zugang zu Boehringer Ingelheims großtechnischen Anlagen zur biopharmazeutischen Produktion in Säugetierzellen in Biberach. Im Gegenzug erhalten Boehringer Ingelheims Kunden die Möglichkeit,  Rentschlers Anlagen für Prozess-Entwicklung und Herstellung von klinischen Prüfmustern im mittleren Maßstab zu nutzen.

Die Zusammenarbeit ermöglicht den Kunden aus der Pharma- und Biotech-Industrie die kombinierte Entwicklungs-und Herstellungserfahrung und die Produktionsinfrastruktur beider Unternehmen zu nutzen, Serviceleistungen können durch die gewonnene Flexibilität optimal auf Kundenwünsche abgestimmt werden. Beide Unternehmen liegen in räumlicher Nähe zueinander und verfügen über kompatible Prozess-Technologien, so dass ein nahtloser Übergang bei Projekttransfers gewährleistet ist.

Rentschler Biotechnologie, ein Full-Service-Auftragshersteller für biopharmazeutische Prozess-Entwicklung und Produktion in Säugetierzellen vom kleinen bis mittleren Maßstab, besitzt zurzeit acht unabhängige GMP-Produktionsanlagen mit Fermentervolumina bis zu 500 Litern. Eine weitere 2.500 L Anlage wird derzeit in Betrieb genommen. Boehringer Ingelheim bietet ähnliche Leistungen und Technologien allerdings für die großtechnische Marktproduktion und betreibt eine der weltweit größten Produktionsanlagen mit Fermentervolumina bis zu 15.000 Litern.

„Die Zusammenarbeit mit Boehringer Ingelheim wird den Nutzen unserer Dienstleistungen weiter erhöhen. Beide Unternehmen werden von der gemeinsamen Erfahrung sowie dem leichten Prozess-Transfer von dem kleinen/mittleren Maßstab in den großen Maßstab profitieren“, kommentiert Dr. Wieland W. Wolf, Stellvertretender Geschäftsführer der Rentschler Gruppe.

Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President der Corporate Division  Biopharmaceuticals, Boehringer Ingelheim GmbH:“Rentschler Biotechnologie ist ein starker Partner für Prozessentwicklung und Herstellung von klinischem Prüfmaterial in Europa und ergänzt unser weltweites Netzwerk strategischer Produktionsallianzen. Basierend auf kompatiblen Prozesstechnologien und Boehringer Ingelheims geschütztem Know-How und Erfahrung in Hochtiterverfahren mit hoher Ausbeute kombinieren wir modernste Prozessentwicklung bei Rentschler für zügige Bereitstellung von klinischem Prüfmaterial mit einem nahtlosen Technologietransfer zur kommerziellen Fertigung im Großmaßstab bei Boehringer Ingelheim.“

Link zur Pressemitteilung:

http://www.b3c.de/php/popup.php?id=104

Über Rentschler Biotechnologie – www.rentschler.de

Rentschler Biotechnologie GmbH ist ein Unternehmen der Rentschler Gruppe mit Sitz in Laupheim, Deutschland. Als internationales Full-Service-Auftragsunternehmen mit 340 hochqualifizierten Mitarbeitern hat Rentschler Biotechnologie über 30 Jahre Erfahrung mit der Entwicklung, Produktion und Zulassung von Biopharmazeutika, konform mit den internationalen GMP-Standards. Zum Servicespektrum des Unternehmens gehören auch die Zulassungsberatung und Fill & Finish. Rentschler zählt zu den Pionieren bei der Entwicklung und Herstellung von biopharmazeutischen Produkten und war weltweit das erste Unternehmen, das die Zulassung für ein Interferonpräparat erhalten hat. 2006 gab Rentschler ein Investitionsprogramm von 50 Millionen Euro zur Erweiterung der Produktionsanlagen bekannt. Die erste neue 2.500 L GMP Anlage befindet sich zurzeit in der Qualifizierung (IQ/OQ) und wird im Juni 2008 in Betrieb gehen.

Über Boehringer Ingelheim - www.boehringer-ingelheim.com/biopharm

Der Unternehmensverband Boehringer Ingelheim zählt weltweit zu den 20 führenden Pharmaunternehmen. Mit Hauptsitz in Ingelheim am Rhein ist Boehringer Ingelheim weltweit mit 135 verbundenen Unternehmen in 47 Ländern tätig und beschäftigt fast 39.800 Mitarbeiter. Schwerpunkte des 1885 gegründeten Unternehmens in Familienbesitz liegen in der Forschung, Entwicklung, Produktion sowie dem Marketing neuer Arzneimittel mit hohem therapeutischem Nutzen für die Humanmedizin sowie die Tiergesundheit. Im Jahr 2007 erwirtschafte Boehringer Ingelheim Gesamterlöse von 11 Milliarden Euro. Fast ein Fünftel der Einnahmen aus dem größten Bereich – verschreibungspflichtige Medikamente – investierte das Unternehmen in die Forschung und Entwicklung neuer Medikamente.

Boehringer Ingelheim ist eines der führenden Unternehmen in der Auftragsentwicklung und -herstellung von Biopharmazeutika und bietet an seinen Standorten in Biberach/Riss (Deutschland) und Wien (Österreich) die gesamte biopharmazeutische Prozesskette an – von der Entwicklung der Produktionszelle über die Prozessentwicklung bis zur Herstellung des Marktproduktes im wirtschaftlichen Maßstab. In den Produktionsanlagen werden biopharmazeutische Produkte wie therapeutische Proteine, Fusionsproteine, Protein-Scaffolds, monoklonale Antikörper, Antikörperfragmente und Plasmid-DNA-Produkte im Großmaßstab hergestellt. Am Standort Biberach liegt der Schwerpunkt der biopharmazeutischen Herstellung auf der Hochexpression in Säugetierzellkulturen mit Ausbeuten weit über dem Branchenstandard in ACF-Medien (ohne tierische Komponenten), am Standort Wien auf der Hochexpression in Mikroorganismen und Hefekulturen mit außergewöhnlich hoher Produktivität unter Einsatz selbst entwickelter Systeme. Auf dem Gebiet der Herstellung von Plasmid-DNA-Produkten setzt Boehringer Ingelheim in Österreich den weltweiten Maßstab und beliefert sowohl frühe als auch späte klinische Studien für seine internationalen Auftraggeber mit Gentherapeutika und DNA-Impfstoffen.

Weitere Informationen: http://www.boehringer-ingelheim.com/biopharm

Munich and Freiburg, Germany, May 7, 2008 / b3c newswire / – CRELUX and ProQinase announced today that they have entered into a joint agreement to supply customers with crystal-grade protein kinases and readily available kinase complex structures.

Under the agreement, CRELUX and ProQinase will establish and continuously expand an off-the-shelf crystal-grade protein kinase portfolio, optimized and quality-controlled for successful crystallization. In addition, the two companies will work closely together to provide new crystal-grade protein or crystal structures, tailored to meet customers’ needs.

Recombinant protein kinases, optimized for crystallization, will be produced and exclusively marketed by ProQinase, while CRELUX will continue to provide customers with crystallization and x-ray crystallography services. CRELUX will support ProQinase by performing crystallization quality control for each crystal grade protein batch. At the same time, ProQinase will grant CRELUX privileged direct access to kinase crystal-grade protein.

“This new joint crystal-grade kinase platform offers tremendous advantages: It enables us to continue to focus on our core expertise – complex structure solution – while leveraging the expertise of ProQinase to significantly strengthen our capacities in protein expression,” commented Dr. Michael Schäffer, CEO of CRELUX.

“The combination of CRELUX’s expertise in protein crystallography and ProQinase’s know-how in kinase cloning and expression makes the two companies the partners of choice for all customers interested in kinase crystallography,” noted Dr. Christoph Schächtele, CEO of ProQinase.

CRELUX has used its state-of-the-art structural biology platform to solve more than 250 crystal and co-crystal structures for pharma and biotech companies. This platform encompasses all steps – from target cloning and expression all the way to high-throughput protein crystallization and in-house x-ray crystallography.

ProQinase, as part of its integrated protein kinase technology platform, offers more than 150 recombinant human protein kinases – all produced in-house – and provides all types of in vitro testing services, with more than 220 protein kinases.

Notes to editors

CRELUX GmbH ( www.crelux.com) provides fast and affordable access to co-crystal structures for biotech and pharma companies worldwide. Three dimensional structures of target-compound complexes are unique sources of information during the rational drug discovery process. Straightforward availability of structural data at an early stage of the drug development process significantly enhances productivity and success rates during hit selection, lead generation, and lead optimization. CRELUX has streamlined the processes of structure generation and solved hundreds of co-crystal structures using an integrated technology platform. In addition to customer designed projects crystallization conditions of numerous relevant therapeutic targets are available within the Off-The-Shelf Program of CRELUX. Off-The-Shelf target structures are delivered at a fixed price and short turn around times, facilitating affordable access to structural information.

ProQinase GmbH ( www.proqinase.com) provides an Integrated Protein Kinase Technology (iProKiTe®) Platform for preclinical drug development of protein kinase inhibitors. More than 150 highly active recombinant kinases are offered for sale and more than 220 kinases are available for in vitro testing services (HTS and selectivity profiling etc.). Cellular and in vivo test systems including orthotopic tumor models allow further testing of lead compounds. A Clinical biomarker analysis service supports the evaluation of clinical trials.

Carlsbad, Calif., and Beltsville, Md., May 7, 2008 – In research demonstrating that RNA previously thought to have no biological relevance may be of use for therapeutic and diagnostic targets, Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and BioServe, the leading provider of clinically annotated tissue samples and provider of molecular marker research services, today announced that their technologies identified noncoding RNAs that were differentially expressed in healthy and diseased tissue. These micro ribonucleic acid (miRNA) sequences were either up or down-regulated between matched samples of RNA isolated from healthy colon and colorectal cancer tissues.  Data was presented in a poster at the annual meeting for the American Association for Cancer Research.

Invitrogen researchers used RNA samples from BioServe’s OncoRNA (http://www.bioserve.com/products/oncoRNA.cfm) product line, a series of RNAs isolated from fresh-frozen, fully annotated tumor and adjacent normal tissues, to probe the Ncode(TM) Human miRNA microarray V3.  Ncode(TM) Profiler software identified miRNAs that were either up- or down-regulated in tumor versus healthy tissue, and researchers used quantitative PCR to validate the findings.

“Using the high quality RNA samples from BioServe, we were able to identify novel microRNA sequences that could potentially be involved in the generation of new tumor tissues, particularly in colorectal cancer,” said Chris Adams, research and development leader of Epigenetics at Invitrogen.  “If more stringently validated, these disease-related microRNAs may eventually serve as targets for diagnostic or therapeutic development.”

MicroRNAs are short RNA sequences that do not code for specific proteins but are extremely important in the regulation of gene expression; they are implicated in several disease states including cancer and heart disease.  Among the activity of miRNAs is the triggering of messenger RNA (mRNA) degradation and the inhibition of protein translation – the process of assembling amino acids into proteins based on the instructions contained in mRNA sequences.  Invitrogen’s Ncode(TM) Human miRNA microarray V3 consists of miRNA content from multiple sources, including the Sanger 10.0 miRNA database and novel miRNAs unavailable in public databases, giving users access to strong content for identification and study of miRNAs.

“MicroRNA is making headlines in drug discovery for its ability to fine tune the activity of genes and its part in the formation of cancer,” said Kevin Krenitsky, chief executive officer, BioServe. “This makes it all the more critical that researchers can be certain they are working with stable, highly annotated samples collected under rigorous ethical and scientific protocols. We created OncoRNA to respond to this need, providing bench-ready RNA for tomorrow’s discoveries.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository(R), a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology — placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.