Expanded Testing to Assess Immunogenicity in Biologics Now Offered
June 9, 2010 - Charles River Biopharmaceutical Services (BPS) has experience developing, validating and implementing in vivo, in vitro and ex vivo assays to study immunogenicity and biological potency. To address the evolving needs of our customers, we are expanding our existing immunogenicity portfolio of in vivo immunopotency assays, ELISAs and cell-based assays to include cell-based neutralizing assays.
Cell-based neutralizing assays can be used to detect the presence of anti-drug antibodies that can interfere with the drugs’ effectiveness, an important consideration in immunogenicity risk assessment. These assays can also be utilized in the optimization of biologics and biosimilars during both preclinical and clinical investigations. We will work closely with customers to assist in the transfer, development and validation of these types of assays in a GxP-compliant manner.
For more information about this new immunogenicity assay or to learn more about the variety of other services BPS provides, please email firstname.lastname@example.org or call 1-877-CRIVER-1.
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We offer a package of well-established, state of the art in vitro mode of action assays that are suitable for early phase biocomparability studies, lot release and stability. These tests can accelerate the time it takes to get a new product ready for market submission.
Charles River has developed and optimized the RT-PCR test for vertically-transmitted poultry pathogens for testing SPF flocks as defined by the PhEur 5.2.2.
May 20–May 22
Please visit Charles River tabletop #611 to discuss our full portfolio of products and services, including our Preclinical Services, as well as our Biopharmaceutical Services, which deliver client-focused solutions for the specific testing and manufacturing requirements of your biologic.
May 23–May 23
This full-day seminar encompasses selected topics from our Charles River Short Course on Laboratory Animal Science. We would like to acknowledge Michigan State University for hosting this event and extend our heartfelt thanks to guest speaker Dr. Danielle Ferguson.
This position is responsible for serving as a as a study director (SD), project scientist (PS) and/or principal investigator (PI) in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research; coordinating all phases of the study planning process with appropriate departments; generating high-quality project plans, protocols, amendments and reports appropriate for assigned studies; reviewing, interpreting, integrating and presenting data on assigned studies; and functioning as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
This position is responsible for managing international aspects of US Federal income tax compliance; assisting with international tax planning, including identification of planning opportunities, designing and implementing plans, and transfer pricing process; overseeing quarterly ETR forecast process; and participating in the tax provision process, including assessment of tax risks, documentation of key positions, and review of non-US tax provision submissions.
Charles River Laboratories, Inc.