|By Marketwired .||
|March 24, 2014 03:24 PM EDT||
TUSTIN, CA -- (Marketwired) -- 03/24/14 -- Avid Bioservices, Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals, Inc., today announced that recent studies evaluating a new suspension Chinese Hamster Ovary (CHO) expression system identified several process parameters and a combination of feeds that significantly increased titer and productivity. The project included the selection of stable high producing subclones using ClonePix FL technology, optimizing media feeds through an intensive screening program and further characterization of the design space. The study resulted in a 10x improvement in productivity, while yielding a comparable product profile. The case study detailing these findings will be presented at IBC's Biopharmaceutical Development & Production Week Conference, to be held in San Diego, CA, March 24-27, 2014.
"The goal of this project was to implement a new expression technology and to apply our expertise in upstream process development to achieve a high producing cell line for the client. The result was a project that included screening of seventeen chemically defined, animal component free media and feeds and evaluating their effect on titer. In addition, we applied Design of Experiments (DoE) methodologies to map out the design space and eventual verification at larger scale. The result was an approximate 10-fold increase in titer with a comparable product," said Dr. Jeanette Doerr, Senior Scientist of Process Sciences at Avid Bioservices and leader of the project. "When our team applied these techniques to additional molecules, the results were consistent with the initial study, demonstrating that we can apply this approach to our clients' molecules with a high level of confidence in achieving similar successes. With a 10-fold increase in titer overall, we are optimistic that the upstream process developed during these studies has the potential to become a platform process."
As part of its integrated services portfolio from plasmid to delivery of drug substance or drug product, Avid offers cell line development and cell culture optimization services to clients under GMP, including, transfection, subcloning, clone selection using ClonePix technology and generation of R&D material to support early downstream development and pre-clinical studies. Following delivery of an optimized cell line, a robust upstream process is developed through the use of tools such as DoE and Quality by Design (QbD) studies, and optimized and characterized through media/feed screening that utilizes high throughput (HTPD) to increase titer, while maintaining critical quality attributes (CQAs).
"We have been working steadily to implement new technologies at Avid that will help our clients as they move their products toward commercialization. This case study is a good example of our ability to implement new technologies and to apply our core expertise in process optimization and product characterization in order to meet our customers' needs," said Connie Chang, Director of Process Sciences at Avid Bioservices. "Our goal at Avid is to be a partner for product development throughout the clinical trial process, helping clients to meet tight development timelines, while implementing consistent improvements that will allow them to advance to later stage clinical development and to eventually commercialize their products. This new expression technology appears to be robust and gives us another great option to offer to our clients."
Poster Presentation Details:
Title: "Cell Line Development and Upstream Process Optimization of a Suspension CHO Expression System"
Dates: Monday, March 24, 2014 -Tuesday, March 25, 2014
Authors: Jeanette Doerr, Ryan Rosson, Calla Montelongo, Vince Nguyen, Connie Chang
In addition, Avid Bioservices will be hosting conference attendees at booth #304 in the exhibit hall Monday, March 24 - Thursday, March 27, 2014.
For additional information on IBC's Biopharmaceutical Development & Production Conference, please visit: http://www.ibclifesciences.com/BDPWeek/overview.xml
About Avid Bioservices
Avid Bioservices provides a comprehensive range of high quality cGMP manufacturing services for the biotechnology and biopharmaceutical industries to support the manufacture of cGMP clinical phase and commercial products. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include GMP clinical and commercial product manufacturing, purification, bulk packaging, final product filling, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.com.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead immunotherapy candidate bavituximab while seeking a partner to further advance its novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
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