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PharmaGap Completes Manufacturer Site Audits Required for Clinical Trial Submission
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PharmaGap Inc. has reported that quality audits for cGMP (current Good Manufacturing Practices) grade peptide have now been completed by PharmaGap under the direction of Dr. Ken Sokoll, Vice President of Clinical Development and Chief Operating Officer.
The audits were performed at the manufacturers' sites and represent a required step toward the submission of an Investigational New Drug ("IND") Application in the United States.
The manufacturers have produced research grade GAP-107B8 and variants for PharmaGap's in vitro and in vivo testing and development program over the past 12 months.
The choice of manufacturer is targeted to be made in November by Dr. Sokoll following assessment of the manufacturers' capability for cost-effectively delivering quality-controlled, stable product in quantities and on an expedited timeline, which is required for use in all future testing.
This future testing includes scale-up of liposomal formulations and formal GLP safety-pharmacology and toxicology testing for GAP-107B8 during 2012, and all subsequent testing in PharmaGap's clinical trials in humans thereafter.
Regulatory requirements for IND Applications provide that pharmaceutical companies bringing new drugs into clinical trials are ultimately responsible to ensure that processes are in place to assure the control of outsourced activities and quality of purchased materials.
Audits of manufacturers are required in order to meet PharmaGap's responsibility to assess, prior to selection of manufacturer, the suitability of the manufacturer to produce in a timely manner the drug product using defined procedures and quality control systems.
Dr. Sokoll commented that "The completion of this audit process and establishment of a manufacturer of clinical grade source for GAP-107B8 peptide in November is a key component in our ability to meet all testing and data generation requirements for the IND submission next year."
