AMPAC Fine Chemicals LLC (AFC), a wholly-owned subsidiary of
American Pacific Corporation, has concluded an agreement with Chimerix, Inc. to
validate at commercial scale the manufacturing process for the API in
Chimerix’s broad spectrum antiviral drug candidate, CMX001, which is being
developed for the prevention and treatment of smallpox. Chimerix will provide
the investigational drug product under a Prime Contract with the U.S.
Government Agency BARDA (Biomedical Advanced Research and Development
Authority). According to Kenneth I. Moch, President and Chief Executive Officer
of Chimerix, “We look forward to working with AFC and BARDA to harness the
full potential of CMX001 to address the biodefense threat represented by
smallpox.”
The validation campaign will be conducted in AFC’s recently
completed second semi-works unit. The unit is located within a secured
perimeter (security-alarmed fencing, cameras, controlled personnel access)
segment of AFC on the DoD-regulated campus of Aerojet/GenCorp in Rancho Cordova. “This facility offers a state of the
art, remotely operated process plant which can safely run hydrogenations and
hazardous chemical processes, while containing reactants and products with
Occupational Exposure Limits (OELs) down to 0.5 µg/m3, combining two of the
core strengths of AFC. Equipment consists of 4 reactors (from 300-750 gal) and
one 2.0 m2 Hastelloy filter-dryer. The unit is ideally suited for the
production of APIs required by companies like Chimerix,” stated Larry
Zeagler, Executive Director of Product Management for AFC.
“This agreement further solidifies our position as a
supplier with world class cGMP manufacturing capabilities in the United States.
AFC is committed to maintaining the domestic assets and services needed by our
customers to provide materials of critical importance to health and
safety,” stated Aslam Malik, President of AFC.
