Sterility Testing for Biologics to Expand with New Isolator
October 13, 2011 - Isolator sterility testing is now the preferred method for companies developing biologics as it provides a more controlled environment, which reduces the risk of sample contamination and the probability of false positives. In an effort to expand our sterility testing services, a new isolator in Malvern, PA will be coming online in early 2012. This addition will give Charles River two isolator systems–one in the US (Malvern, PA) and one in Europe (Ballina, Ireland)-expanding our experience dealing with both US and European Pharmacopoeia regulations and providing us with a backup isolator to eliminate testing delays.
In addition to sterility testing via isolators, we have individual clean room suites outfitted with an ISO 5 Biological Safety Cabinet (BSC) or Laminar Air Flow (LAF) cabinet for sterility testing at these sites.
Note: For both options, all procedures comply with GMP guidelines.
Note: For both options, all procedures comply with GMP guidelines for monitoring of the classified areas (viable and non-viable monitoring).
We offer technical guidance to clients with questions regarding sterility testing. For additional information on what type of testing is appropriate for your needs, contact us at firstname.lastname@example.org.
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We have established an in vivo screening platform to provide fast and cost-effective screening of compound effects on motor behavior and brain functionality for the study for central nervous system diseases.
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.
May 28–Jun 01
The International Bone and Mineral Society (IBMS) and the Japanese Society for Bone and Mineral Research (JSBMR) are excited to sponsor the second joint scientific meeting by the two organizations.
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.