Optimizing Purification Techniques to Remove Process-Related Impurities With No Impact on Critical Quality Attributes; Strategies for Developing Process-Specific Host Cell Protein Antigens That Can Be Used for the Development of Impurity Assays
TUSTIN, CA--(Marketwired - Mar 31, 2015) - Avid Bioservices, Inc., the contract manufacturing subsidiary of Peregrine Pharmaceuticals, Inc., today announced that it will present three posters at IBC’s Biopharmaceutical Development and Production Week Conference to be held in Huntington Beach, California, March 30-April 2, 2015. These presentations will highlight Avid’s expertise in optimizing purification techniques to remove process-related impurities, as well as strategies for developing process-specific host cell protein antigens that can be used for the development of impurity assays.
Avid will present the following posters, which will be on display Wednesday, April 1st and Thursday, April 2nd at the Hyatt Regency Huntington Beach Resort and Spa Hotel:
“Generation of Host Cell Protein Assay Reagents for Development of a Process-Specific Host Cell Protein Assay” Presented by Jeanette Doerr, Ph.D., Senior Scientist, Molecular Cell Biology
“Variability of Triton X-100 Impacts Product Solution Clarity During Solvent/Detergent Treatment” Presented by David Briggs, Ph.D., Associate Scientist, Manufacturing Science and Technology
“Reducing Residual DNA with No Impact on Critical Quality Attributes: A Case Study Using Modified Ceramic Hydroxyapatite (CHT) Conditions to Selectively Remove Host Cell DNA Contaminants”
Presented by Payam Farahani, Associate Scientist, CMC & Process Sciences
“In one case study, the Avid teams share examples of process improvements made by applying innovative techniques for purification, while maintaining critical quality attributes (CQAs). We have been able to make significant advancements in purification techniques for complex glycoproteins in order to meet the specific needs of our clients’ advancing programs,” said Connie Chang, senior director of CMC and Process Sciences for Avid Bioservices. “In another case study, we share strategies for generating process specific Host Cell Proteins (HCP) that can be used to develop reagents for process specific impurity assays. Host cell proteins contaminants for biological products are of significant interest to regulatory agencies and this presentation shares our experience in developing the reagents that can be used to develop process specific HCP assays for late stage development and commercialization.”
“Increasing the consistency of manufacturing processes is critical for our clients. This is achieved by better understanding the critical process parameters, including the materials used during production and by making adjustments that do not effect critical process characteristics,” said Gene Yoshioka, senior director of manufacturing for Avid Bioservices. “One of the case studies being presented demonstrates the potential impact that raw material quality can have on cGMP production. Through better process understanding, we are able to achieve consistent process performance and a high level of quality for the products delivered to our clients.”
In addition, Avid Bioservices will host conference attendees in booth #114 in the exhibition hall Monday, March 30th - Thursday, April 2nd.
For more information on IBC’s Biopharmaceutical Development & Production Week Conference, please visit: http://www.ibclifesciences.com/BDPWeek/overview.xml
About Avid Bioservices
Avid Bioservices provides a comprehensive range of high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 20 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid’s services include cGMP 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 development and 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, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company’s lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the “SUNRISE trial”) along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. 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.
CONTACT INFORMATION
For further information please contact:
Chris Keenan or Kelly Pisarev Lord
(800) 987-8256
www.avidbio.com
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