Surrey, UK, 8th October 2009 - NextPharma, a leading service provider of product development, contract manufacturing, cold chain storage and logistics to the pharmaceutical and biotechnology industries is pleased to announce that it has expanded its core capabilities through the addition of Clinical Trial Services at its San Diego, California facility.
These new services mirror NextPharma’s existing Clinical Trial Services capabilities available at its Göttingen, Germany facility. NextPharma’s Clinical Trial Services capabilities include randomization double-blinding, generation of emergency letters, packaging, kitting, labelling (Phase I – Phase IV studies), cold-chain storage, distribution, return accountability and destruction.
Sean Marett, Managing Director NextPharma Technologies Product Development Services, commented: “We are delighted to add Clinical Trial Services to our San Diego facility as we continue to enhance our world class product development, contract manufacturing and logistics services globally”.
Bill Wedlake, CEO, NextPharma 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 United States”.
NextPharma’s Göttingen Clinical Trials Services facility, completed in December 2008, has extensive capacity in packaging suites for primary and secondary packaging and an extended cold storage area (2-8 °C and - 20 °C). It 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. Moreover, a dedicated suite for the packaging of humidity sensitive investigational medicinal products is also available.
NextPharma’s Göttingen Clinical Trials Services facility has been designed specifically to meet the needs of pharmaceutical, biotechnology, contract research organizations and universities. As well as 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. It operates to strict cGMP guidelines, meets all European compliance regulations and is in the process of being validated to meet FDA regulatory requirements.
NextPharma’s North American operation based in San Diego, California, serves small to large companies world wide in the biotechnology, pharmaceutical, diagnostic, and medical device markets. Its 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. This facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of sterile injectables manufacturing, with particular expertise in pharmaceutical development and manufacture of oncology medicines.
About NextPharma
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industries. We offer a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing.
We are a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally we have significant expertise in paediatric drug formulation, development and manufacture.
We operate globally with seven product development centers, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan. We have 1,200 employees dedicated to serving over 200 customers world wide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharmaceutical and biotechnology companies.
We have a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of our sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.
