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European BioPharmaceutical Review

Engineering Bacteria for DNA Medicine Production

Plasmids prepared from Escherichia coli are fundamental tools in molecular biology, and their most recent applications as DNA medicines for gene therapy and DNA vaccines is a field that has expanded rapidly in the last decade. DNA vaccine candidates are in clinical trials against important diseases such as HIV, tuberculosis, malaria and various cancers; plasmids are also important in gene therapy and anti-cancer therapies. Unlike DNA vaccines, gene therapies can require relatively large doses of purified plasmid DNA.

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By Dr Rocky Cranenburgh, Molecular Genetics Team Leader, Alexandra Bloor, Molecular Biologist, Matthew Leckenby, Molecular Biologist and Julian Hanak, Director of Production at Cobra Bio-Manufacturing Plc

Rocky Cranenburgh is the Molecular Genetics Team Leader at Cobra. He has a BSc from the University of Bristol and a PhD from the University of Newcastle. Shortly after joining Cobra in 1997, Rocky moved to the Department of Biochemistry at the University of Oxford for a research collaboration, then relocated to Cobra's headquarters at Keele.

Alexandra Bloor is a Molecular Biologist in Cobra's Molecular Genetics Team. She has a BSc from Nottingham Trent University. Alex's research positions prior to joining Cobra in 2001 include the Molecular Genetics Unit of Cambridge University and the Molecular Sciences Institute, La Jolla, California.

Matthew Leckenby is a Molecular Biologist in Cobra's Molecular Genetics Team. He has a Licence en Biologie from Geneva University. Prior to joining Cobra in 2001, Matthew held a studentship at the Institute of Plant Genetics and Crop Plant Research, Germany.

Julian Hanak is the Director of Production at Cobra. He has a BSc from University College London and an MSc from the University College of North Wales. He has held positions in cell and microbial fermentation at the National Institute of Medical Research (Mill Hill), Bioproducts Laboratory (Elstree) and Zeneca Pharmaceuticals (Cheshire). He joined Cobra in 1994 to manage production operations.
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Rocky Cranenburgh
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Alexandra Bloor
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Matthew Leckenby
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Julian Hanak
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

Azopharma Product Development Group, Inc

HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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