LEIDEN, Netherlands and PARSIPPANY, N.J., June 25 /PRNewswire/ — 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 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. (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(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 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: 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).
SOURCE DSM Pharmaceutical Products