TUSTIN, CA -- (Marketwired) -- 01/24/14 -- Avid Bioservices, Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals, Inc., today announced that recent studies demonstrated that it is possible to control key product quality attributes through cell culture conditions. Using Design of Experiments (DoE), the cell culture conditions within the process design space were identified during process understanding and modeling studies that allowed for the control or manipulation of afucosylation (G0) levels. This case study will be presented at the Well Characterized Biotechnology Pharmaceutical (WCBP) 18th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, to be held in Washington, DC, January 27-30, 2014.
Glycosylation is a common posttranslational modification that has shown to be a critical quality attribute (CQA) of recombinant monoclonal antibodies. In particular, the level of afucosylation (for example, G0) is a key glycosylation parameter associated with enhanced antibody activity, for a monoclonal antibody in clinical development.
"By applying a Quality by Design (QbD) approach, we gained a greater insight into how to better control the process, as well as the creation of a clearer blueprint for future development in order to increase our efficiency and, in the end, deliver a more robust process to our clients," said Connie Chang, director of process sciences for Avid Bioservices. "The control of glycosylation and particularly afucosylation is challenging and these results are an important development for this monoclonal antibody. The results from our recent studies show that two Critical Process Parameters significantly affect the afucosylation levels on the antibody. This understanding enabled process modifications within the design space to increase the G0 levels for an existing client cell line. In addition, the increased understanding of process parameters has allowed us to identify additional process controls that allow for more consistent CQAs from batch to batch."
Poster Presentation Details:
Title: "Characterization of Bioreactor Conditions Effect on Afucosylation"
Date: Wednesday, January 29, 2014
Time: 3:15 - 4:15 P.M. EST
Location: Poster Board # P-226-W
Authors: Vince Nguyen, Michael Brown, Roy Sevilla, Aditi Iyengar, Gary Larson, Karyn Pinson, Payam Farahani,
Michael Wang, Calla Montelongo, Olegario Garcia, Mary Wakabayashi, Mary Knauer, Connie Chang
In addition, Avid Bioservices will be hosting conference attendees at booth #19 in the exhibit hall.
For additional information on the WCBP 18th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, please visit: https://m360.casss.org/event.aspx?eventID=72301
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.