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| home > ebr > autumn 2001 > innovative facility concepts for biopharmaceutical multipurpose pilot and production plants |
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European BioPharmaceutical Review
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| The manufacturing requirements of biologics, raw materials, starting materials, excipients and APIs (secondary metabolite, prokaryat, cell culture, transgenic plants and animals, blood products, vaccines and so on), and the dosage form required (aseptic filling, vials, ampoules, syringes, pulmonary systems, transdermal systems etcetera), strongly influence the design concept for pharmaceutical facilities. The greatest influential factors on the design of such facilities are the purpose of the plant (mono or multipurpose), and the size of the plant (the production of cytokines requires less equipment and equipment that is smaller than bulk or rHSA, for example). The production of clinical trial material also needs a smaller plant than for market supply. |
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By Dr Hermann Allgaier, Managing Director of Operations at LSMW GmbH
Dr Hermann Allgaier is the Managing Director of Operations for LSMW GmbH, a company providing consultancy, design, construction and validation services for the pharmaceutical and biotech industry. His 17 years of experience include upstream and downstream processing, engineering, analytical services and internal compliance. He was Responsible Head and led the worldwide process development of new chemical entities at Boehringer Ingelheim in Germany.
Dr Allgaier has made numerous presentations and has had work published in the
areas of biopharmaceutical development, manufacturing and general compliance. He is a Member of PDA, ISPE and APV, where he heads the biopharmaceutical section. Dr Allgaier studied Biochemistry at the University of Tübingen, where he received the Friedrich Weygand Award for his PhD work in the field of peptide antibiotics.
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Clinical Trials in CNS
25-26 November 2008, Copthorne Tara Hotel, London, UK
SMi present their 7th annual conference… Clinical Trials in CNS 25th to 26th November 2008, Copthorne Tara Hotel, London, UK
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