Regis Looks to Extend cGMP Services to the Oncology Market
Regis Technologies announced new potent compound capabilities this month for the development of oncology drug substances.
Regis Technologies is proud to announce the commissioning and start up of their new Potent Compound Suite (PCS) for 2015.
Regis is a contract manufacturing organization operating a 36,000 square foot, cGMP facility in Morton Grove, Illinois. The PCS addition will provide for small molecule cGMP manufacturing of potent compounds up to about one kilogram per batch.
Regis’ Director of Business Development, Wayne Nowicki, states “We see the PCS as an important asset to serve the growing oncology market as more companies look to advance their lead candidates into the clinic.” Nowicki addressed industry colleagues in a well-received talk about the PCS at Informex Exhibition 2015 earlier this month.
The PCS project was approved by Regis’ Board of Advisors in 2013 to address customer demand and industry trends. Regis’ Manager of Process Engineering, Dragan Ristic, supervised the design and construction of the suite.
Proper handling of potent compounds requires the use of specialized facilities that are carefully designed to minimize containment risks. This involves equipment such as isolators, laminar flow hoods, and local exhaust ventilation appropriate for potent compound handling. Thus, the project included several phases from concept design to construction.
Construction of the PCS has been completed. The suite validations, cGMP qualifications, and employees trainings are currently in progress. Expert consultants also worked with the Quality Control and Analytical Method Development staff to choose the best laboratory and personal protective equipment for potent compound handling and have already conducted the first phase of employee training.
The next big step would be the surrogate powder testing, which will be performed by a third party in order to evaluate the containment performance of the facility and to verify the proposed operating procedures. Regis chemists would simulate the real time operations by using a surrogate API in order to challenge the installed equipment.
The on-site testing is scheduled for March 4-5, 2015, and analytical results will be available within 3 weeks of the collection. Consequently, a draft report for Regis’ review will be available within 5 days of receipt of laboratory results.
When testing is complete, the PCS will be available for projects. Regis expects the suite to be active by April.
Regis is excited to add the new potent compound capabilities to its almost 60 year long resume. Founded in 1956, Regis has long been recognized as a premier partner for the clinical and commercial production of small molecule APIs. Its outstanding compliance history, technical and project management teams, and central US location have made it the supplier of choice for emerging and mid-size pharma.
More information on Regis’ capabilities, team, and outstanding compliance history is available throughout the website.