While cytotoxicity testing has been a requirement for certain formats in the past, the recently revised USP 661 chapters have significantly expanded its applicability, including packaging components intended for use with solid oral dosage forms
Whitehouse, NJ (PRWEB) May 04, 2016
Whitehouse Laboratories is pleased to announce the official launch of the Cytotoxicity Laboratory, created to perform testing per USP 87 and ISO 10993. This addition provides new and existing clients the opportunity to have biocompatibility testing of their medical devices, container-closure systems, raw materials, and drug substances under the same roof as their other analytical assessments. This will also enable Whitehouse Labs to better serve our customers under the revised USP 661 chapters.
“While cytotoxicity testing has been a requirement for certain formats in the past, the recently revised USP 661 chapters have significantly expanded its applicability, including packaging components intended for use with solid oral dosage forms”, states Brandon Zurawlow, Associate Director of Container Testing & CCIT. “Whitehouse Laboratories has long positioned itself as a ‘one-stop-shop’ for analytical support of API to finished product packaging. The addition of this testing capability is a logical step in the realization of this vision”.
USP 87 testing is performed to evaluate whether a product complies with specified biological reactivity or cytotoxicity requirements. The test method employed may vary, but the fundamental concept is to emulate exposure of a product, either directly or through extraction, to its end user, by exposure to mammalian cells. The reaction is then measured by grading cell viability. The methods employed may be Direct Contact, in which low density materials are directly exposed to the cells, Agar Diffusion, in which higher density materials (or their extracts) are placed on an agar overlay, or Elution, in which an extract of material is directly exposed to the cells.
About Whitehouse Laboratories
The leader in testing, Whitehouse Labs, a division of Albany Molecular Research Inc., offers comprehensive analytical services providing support for manufacturing from development to market. From analytical chemistry and material qualification to packaging optimization, Whitehouse Laboratories is the testing partner for the world's leading Pharmaceutical, Biotechnology, Medical Device, Life Sciences and Consumer Products organizations.