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European Biopharmaceutical Review

The Future of Biomanufacturing

In my previous article, I reviewed the recent history of biopharmaceutical manufacturing, and the factors that have driven the industry to be the size and shape that it is today. In this article, I will be looking at the emerging trends and technologies, and considering the influence that they will have on biopharmaceutical manufacturing in the future.

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By Sharon Grimster, Director of Westerly Projects Ltd

Sharon Grimster started her career working on clinical trials at Guys Hospital Medical School in London. She then moved to Celltech, working in research for four years prior to taking up various management positions within contract manufacturing. Sharon subsequently managed preclinical and clinical development programmes for both new chemical entities and biological entities. Following the mergers with Chiroscience and Medeva, Sharon became Head of Biologics Manufacturing Development. She left Celltech in 2002 and is now a Director of Westerly Projects Ltd, a consultancy company offering development services to the biopharmaceutical industry globally.

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Sharon Grimster
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News and Press Releases

CPhI MEA expert:growing domestic manufacturing is creating new opportunities for international Pharma in the Middle East

Abu Dhabi, 5th August 2019: CPhI Middle East expert Emad Shabbir, Director at EMAD Trade House, states favorable conditions and legislative regulations in Saudi Arabia are resulting in a boom of manufacturers and CMOs partnerships with international pharma companies. With the strategic cooperation between regional generic companies and multinational pharma companies, driving increased local production.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
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