Data published in the Journal of Pharmaceutical Sciences support further development of caffeine as a viscosity reducing agent for subcutaneous formulations of monoclonal antibodies
WOBURN, Mass., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Comera Life Sciences Holdings, Inc. (NASDAQ:CMRA), a life sciences company developing a new generation of biologic medicines to improve patient access, safety, and convenience, today announced the peer-reviewed publication of preclinical data in the Journal of Pharmaceutical Sciences, which provide further evidence of caffeine's viscosity reducing capabilities and support further development of caffeine as a viscosity reducing agent for subcutaneous (SQ) formulations of monoclonal antibodies.
These studies aimed to assess the pharmacokinetic (PK) characteristics of caffeine and its influence on the PK behavior of a representative monoclonal antibody (mAb) ipilimumab. The outcomes show rapid SQ absorption and elimination of caffeine, regardless of whether it was administered alone or in conjunction with the monoclonal antibody. Notably, caffeine exhibited no impact on the PK profiles of ipilimumab with SQ administration. Moreover, when caffeine was injected SQ at various dosage levels, no irritation or adverse effects were observed at the injection site.
"This study is an important validation of caffeine's potential to address critical viscosity challenges in developing subcutaneous biologics," said Robert Mahoney, Ph.D., Chief Scientific Officer of Comera. "The results further support the rapid dissociation of caffeine upon subcutaneous injection and that caffeine does not affect pharmacokinetic profiles of the model monoclonal antibody, both of which are critical features of a successful subcutaneous formulation."
"Comera continues to innovate on the delivery of biologic medicines and this publication reflects our extensive expertise in solving some of the most challenging problems in protein engineering," said Jeffrey Hackman, Chairman and Chief Executive Officer of Comera. "These insights bring us closer to delivering transformative solutions that have the potential to revolutionize the way we administer essential medicines. We look forward to continuing the development of caffeine as a viscosity reducing agent for subcutaneous monoclonal antibody formulations, while also embarking on the expansion of our computational modeling tools to potentially include cutting-edge AI capabilities."
The publication titled, "Preclinical Pharmacokinetic Study on Caffeine as an Excipient for Monoclonal Antibody Formulations," is available online here.