CMC Pharmaceuticals Awarded Phase I SBIR Grant

Solon, OH: The Department of Defense’s (DoD) Chemical and Biological Defense (CBD) Small Business Innovation Research (SBIR) program awarded CMC Pharmaceuticals an SBIR contract managed by the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) (Contract number: W911SR-22-P-006). The Phase I SBIR award will fund the formulation and analytical development of a multi-dose scopolamine hydrobromide trihydrate vial.  The application of this new formulation aims to reduce the logistical burden to military first responders when treating mass exposure to organophosphorus nerve agents (OPNAs).

 

“The team at CMC Pharma is honored to continue assisting the US Military with the award of this SBIR grant,” said Dr. Radomsky, Principal Investigator and President of CMC Pharma. “We will leverage our medical countermeasure development and scopolamine drug product development experience to help the US military treat and prevent casualties against nerve agent exposure.”

 

Currently, a single dose scopolamine vial is being developed alongside an autoinjector to provide adjunct therapy for military personnel exposed to nerve agents. However, a multi-dose scopolamine vial would provide a broader range of options in the different military medical care roles. CMC Pharma will complete the chemistry, manufacturing, and controls development (formulation, analytical, process, and stability studies) of a multi-dose presentation of the scopolamine drug product containing an antimicrobial preservative.

 

Upon the development of the multi-dose vial, CMC Pharma plans to execute future studies to support FDA approval of the drug product and secure the appropriate supply chain including cGMP manufacturing.  CMC Pharma aims to commercialize this drug product for inclusion in the national strategic stockpile.

 

This program complements CMC’s other medical countermeasure development programs for pre- and post- organophosphate exposure for civilian and military applications.  For more information about CMC Pharma’s team, services, and potential partnering opportunities, please contact Jared Heimovitz at jared.heimovitz@cmcpharm.com and visit www.cmcpharm.com.

 

About CMC Pharmaceuticals:

 

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharmaceuticals delivers its specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development, and consulting services to clients globally. CMC Pharmaceuticals offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile, solid, semi-solid/liquid, topical, long-acting, controlled release, and other complex dosage forms.

 

 

 

 

 

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