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| home > epc > winter 2002 > biotechnology - a challenge for young companies and old regulators |
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European Pharmaceutical Contractor
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Biotechnology, especially its pharmaceutical sector, is regarded as one of the most promising areas of industry. These expectations are based on the rapid progress of various scientific disciplines driving biotechnology, such as cell biology, molecular biology, chemical engineering and computer science. Advances in genomics and proteomics are expected to fuel the discovery of targets and tools for new innovative therapies. Most of these therapies will be based on products that are manufactured by biotechnology.
Therefore, the commercial biotechnology sector has grown at an enormous pace, at least in terms of the number of new companies, both in North America, the European Union and elsewhere due to the enthusiasm of the scientists, companies and investors. Indeed, the demand for medicinal products based on biotechnology may exceed the capacity to produce GMP-grade material (1). This article highlights some problems encountered by companies and regulatory authorities dealing with medicinal products based on biotechnology. Despite being global problems, most have been encountered in Finland as well.
Young Companies and Old Regulators
The fact that many of the new biotech companies have been founded by academics who wish to capitalise on their discoveries has created an entirely new situation in the pharmaceutical sector. The close involvement of scientists in the product development shortens the time period from the discovery phase to the product development phase. This can be beneficial but also problematic due to the potential conflict of the interest between science and business, publication and intellectual property, and patients and shareholders (2, 3).
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By Pekka Kurki, MD, PhD, Senior Medical Officer at the Department of Pharmacology, National Agency for Medicines, Finland
Pekka Kurki, MD, PhD, is currently a Senior Medical Officer at the Department of Pharmacology, National Agency for Medicines (NAM), Finland. He is also a current member of the Committee of Proprietary Medicinal Products (CPMP) at the European Medicines Evaluation Agency (EMEA) and a former member of the CPMP/Biotechnology Working Party at EMEA.
Dr Kurki's medical speciality is internal medicine with a subspeciality in rheumatology. He has a teaching affiliation to the University of Helsinki (clinical immunology). His other areas of scientific interest are rheumatology and cell biology. Before joining the NAM in 1997, Dr Kurki worked in the pharmaceutical industry for nine years, both in Europe and in the US.
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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News and Press Releases |
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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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