A new drug manufacturing facility at the School of Pharmacy will simultaneously supply the research community as well as train students in quality assurance and regulatory affairs. The cGMP, or “current Good Manufacturing Practices,” facility is one of only six based at universities nationwide. The facility will produce drug tablets, capsules and powders as well as offer services to both university scientists and pharmaceutical companies that are testing experimental oral medications. Strict controls surround drug manufacturing in the United States to ensure that the drugs people ingest are precisely formulated. The facility will manufacture drugs (tablets, capsules, powders) and offer services to both university scientists and pharmaceutical companies that are testing experimental oral medications.

The Food and Drug Administration requires that drugs used in research be manufactured using the same standards, or “current Good Manufacturing Practices,” that are required for drugs already on the market, explained David Lebo, director of cGMP services.

Specially manufactured, small quantities of drugs, both real and placebo, need to be made for research studies, known as clinical trials. About half of pharmaceutical companies manufacture their own drugs for research. The remainder, along with academic scientists, have to contract with outside vendors.

The cGMP facility at Temple is capable of providing supplies and services for phase I (testing for safety) and phase II (testing for efficacy) clinical trials, which require fewer than 200 patients and are conducted at no more than three sites. The facility can manufacture up to 100,000 tablets for a single clinical trial.

Special features in the facility, designed and operated to meet FDA requirements, include seamless flooring, walls and ceilings made with non-porous materials, and sophisticated air handling. These prevent drug particles from accumulating in seals and cracks and contaminating the next batch of drugs.

Lebo explained that the costs for orders will be similar whether they’re for 30 or 30,000 units of a drug because the bulk of the work — documentation — is the same for all jobs. Ensuring that all regulatory procedures are followed is a massive undertaking, which requires staying current on frequently changing regulations.

Researchers at Temple and elsewhere will be able to use the facility. For more information, contact Lebo at 215-707-5895.

- By Eryn Jelesiewicz