Facility include randomisation double-blinding, generation of emergency letters, packaging, kitting, labelling, cold-chain storage, distribution, return accountability and destruction
NextPharma has expanded its core capabilities through the addition of clinical trial services at its San Diego, California facility.
The company said that these new services mirror NextPharma’s existing clinical trial services available at its Gottingen, Germany facility. NextPharma’s clinical trial services capabilities include randomisation double-blinding, generation of emergency letters, packaging, kitting, labelling (phase I – phase IV studies), cold-chain storage, distribution, return accountability and destruction.
Reportedly, Gottingen clinical trials services facility has a dedicated packaging suite for secondary packaging of high potency drugs, such as cytotoxics and the capability to perform primary packaging under inert gas conditions.
NextPharma’s Gottingen Clinical Trials Services facility has been designed specifically to meet the needs of pharmaceutical, biotechnology, contract research organizations and universities. Along with providing packaging and distribution services for non clinical, phase I and phase II clinical trials, the facility can also offer greater packaging and distribution capacity for large phase III and IV trials.
Additionally, NextPharma’s North American operation based in San Diego, aseptic area has multiple clean room suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms.
The company said that the facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing.
Bill Wedlake, CEO of NextPharma, said: “We are excited by the addition of this new clinical trial service facility in San Diego. This new service will leverage our growing presence in pharmaceutical development and contract manufacturing in the US.”
NextPharma develops, manufactures, packages, and distributes a range of products and formulations, from tablets and capsules to antibiotics, hormones and controlled release medicines.