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           19 October, 2021


    
Category:  Press » Health & Fitness

 

DSM and Crucell Sign Agreement with Avid Bioservices to Serve as First Pre-Approved U.S. Contract Manufacturer of PER.C6(R) Cell Line Proteins

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2008-06-25 03:42:01     
DSM Pharmaceutical Products

DSM Biologics and Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) announced today that they have entered into an agreement with Avid Bioservices, Inc. of Tustin, California to join their Vendor Network. Under the terms of the agreement, Avid will be a pre-approved contract manufacturer (CMO) for licensees of the PER.C6(R) cell line located in the western U.S. Avid is the first U.S.-based contract manufacturer to be awarded this status.

Karen King, president of DSM Biologics notes, "We are confident that Avid's excellent reputation and service level will be instrumental in making the PER.C6(R) technology available to licensees on the West Coast, bringing our technology to a wider regional base as we continue to grow globally."

Steven W. King, president of Avid Bioservices added, "We are honored to achieve the distinction of being the first pre-approved U.S.-based CMO to manufacture proteins and antibodies using the PER.C6(R) cell line. The PER.C6(R) technology is recognized throughout our industry as providing important advantages compared to other platforms, including serum-free medium, scalability and high productivity levels making the system an ideal fit for Avid."

Crucell and DSM last week announced a breakthrough in the production of IgG antibodies using Crucell's PER.C6(R) technology. By employing the PER.C6(R) human cell line and DSM's proprietary XD(TM) technology, a record yield of over 27 grams per liter has been achieved.

The PER.C6(R) technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins, including monoclonal antibodies. Compared to conventional production technologies, the strengths of PER.C6(R) technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions.

Other terms of the agreement were not disclosed. Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. (Nasdaq: PPHM).

About PER.C6(R) technology

Crucell's PER.C6(R) technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. Compared to conventional production technologies, the strengths of PER.C6(R) technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions.

About XD(TM) technology

DSM's XD(TM) technology has been developed as a proprietary system to drive yield improvements in mammalian systems. "XD" stands for extreme density, as the process is able to push the cell density within the bioreactor to maximum productivity.

About Avid Bioservices, Inc.

Avid Bioservices provides a comprehensive range of cGMP manufacturing services for the biotechnology and biopharmaceutical industries. Avid manufactures cGMP commercial product, as well as clinical supplies for all phases of clinical trials. The company's comprehensive range of cGMP services includes cell banking, stability testing, clinical product manufacturing and purification, bulk packaging, final product filling and regulatory support. Avid also provides a variety of process development activities, including cell line optimization, analytical method development and product characterization. Avid has over 10 years of antibody manufacturing experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes. For more information about Avid, visit http://www.avidbio.com.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

About Crucell

Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) is a global biopharma company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and treat primarily infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6(R) production technology. The Company licenses its PER.C6(R) technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The Company employs over 1000 people. For more information, please visit http://www.crucell.com.

About DSM Biologics

DSM Biologics, a business unit of DSM Pharmaceutical Products, is a global provider of manufacturing technology & services to the biopharmaceutical industry. In addition to offering world-class biopharmaceutical manufacturing services, DSM Biologics has co-exclusive rights, along with Dutch biotech company Crucell N.V., to license the high-producing PER.C6(R) human cell line as a production platform for recombinant proteins and monoclonal antibodies. The combination of the PER.C6(R) human cell line and DSM's manufacturing services provides companies with a turn-key biologic manufacturing solution reducing cost, risk and time to market.

DSM -- the Life Sciences and Materials Sciences Company

Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM's products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. DSM has annual sales of almost EUR 8.8 billion and employs some 23,000 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: http://www.dsm.com.

DSM Forward-looking statements

This press release contains forward-looking statements that involve inherent risks and uncertainties. These statements are based on current expectations, estimates and projections of the management of DSM and Crucell and information currently available to both companies. The statements involve certain risks and uncertainties that are difficult to predict and therefore DSM and Crucell do not guarantee that their expectations will be realized. Furthermore, DSM and Crucell have no obligation to update the statements contained in this press release.

Crucell N.V. has identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to the Form 20-F, as filed by Crucell N.V. with the U.S. Securities and Exchange Commission on May 7, 2008, and in particular the section entitled "Risk Factors". Crucell N.V. prepares its financial statements under International Financial Reporting Standards (IFRS).

Specialized in: Dsm - Crucell
URL: http://www.crucell.com
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