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® 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® 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® cell line. The PER.C6®
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® technology. By employing the PER.C6® 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® 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® 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® technology
Crucell's PER.C6® 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® technology lie in its excellent safety profile, scalability and
productivity under serum-free culture conditions.
About XD(™) technology
DSM's XD(™) 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 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®. Peregrine also has in-house manufacturing
capabilities through its wholly owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and bio-manufacturing services
for both Peregrine and outside customers. Additional information about
Peregrine can be found at
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® production technology. The Company licenses its
PER.C6® 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 US. The Company employs over 1000 people. For more information, please
visit 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® human cell line as a production platform for
recombinant proteins and monoclonal antibodies. The combination of the PER.C6®
human cell line and DSM's manufacturing services provides companies with a
turn-key biologic manufacturing solution reducing cost, risk and time to
market.
