NextPharma Expands Capabilities in U.S.

NextPharma has expanded its capabilities with the addition of clinical trial services at its San Diego, CA facility. The company’s clinical services include: randomization double-blinding, generation of emergency letters, packaging, kitting, labeling (Phase I – Phase IV studies), cold-chain storage, distribution, return accountability and destruction.

Bill Wedlake, NextPharma’s chief executive officer, added, “We are excited by the addition of this new Clinical Trials Service facility in San Diego. Our Clinical Trials Services personnel have proven expertise in supporting global clinical trials for pharmaceutical, biotechnology academic and research organizations. This new service will leverage our growing presence in pharmaceutical development and contract manufacturing in the U.S.”

NextPharma’s North American operation based in San Diego, CA, serves small to large companies in the biotechnology, pharmaceutical, diagnostic, and medical device markets. Its aseptic area has cleanroom suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms. This facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing.

NextPharma also has a clinical trials services facility Göttingen, Germany with packaging suites for primary and secondary packaging, a cold storage area, a packaging suite for secondary packaging of high potency drugs, and the capability to perform primary packaging under inert gas conditions, as well as a suite for packaging humidity-sensitive products. The facility operates under cGMP guidelines, meets European compliance regulations and is in the process of being validated to meet FDA regulatory requirements.