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Aseptic filling of vials, ampoules and syringes, together with lyophilisation
(the freeze-drying of liquids), are crucial steps in the manufacture
of pharmaceutical products. While the capacity demands and the total
numbers of products processed will depend on the stage of development
(e.g. clinical phase I, II, III and market launch), the central technological
imperatives and regulatory hurdles remain more or less constant at
all stages. - This is where The Swedish Biotech Center can help. |
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 Swedish Biotech Center integrates pharmaceutical production Although currently under construction, the Swedish Biotech Center will be a specialised, dedicated production site providing facilities, expertise and support for secondary manufacturing processes. It will be an integrated technical/production and incubator site, providing specialised secondary manufacturing expertise and facilities for European Companies, or European operations of multinational companies. The Centre will operate to the highest regulatory standards. Financing The Center has so far been financed by the Swedish Industrial Development Fund and Vitrolife, a successful Swedish pharmaceutical company, established as one of the leaders in manufacturing specialised media components required for IVF procedures. They took the initiative to the Swedish Biotech Centre since they, as many other biotech companies, need more production capacity to fulfil their demands. Vitrolife asked some of the pharmaceutical giants if they could produce some of their products but when they refused Vitrolife decided to establish the Swedish Biotechnology Centre to accommodate its own, as well as other smaller pharmaceutical companies needs. - Our production facility will take a lot of the hassle out of pharmaceutical production, says Anne-May Engdahl, Managing Director of the Swedish Biotech Center. We will take care of the paperwork, fulfilling regulations, packaging design etc. so that the client’s product reaches the market faster. Functionally distinct areas The Centre will do this through three functionally distinct areas. Firstly, it will provide the necessary infrastructure and services in support of early clinical development of new compounds and medical devices, including filling, packaging and distribution, regulatory approval requirements and processes etc. Secondly, it will provide an incubator facility for companies in the early stage of clinical development of therapeutic products or medical devices. Thirdly, it will provide a modular, multi-unit facility for sterile filling and lyophilisation of products in vials or pre-filled syringes aimed primarily at parental products, or assembly of medical devices. In the first step, one stand-alone production unit with automated filling line with capacities of 20,000 dosage units per batch is to be installed. Operational by 2003/2004 “The plan is to have the Centre fully operational by 2003/2004, employing around 30-40 people as well as accommodating companies who will be able to base themselves within the facility The Centre will be located in Mölnlycke, just outside Gothenburg. Vitrolife themselves will be the Centre's first client but Engdahl has contacts with several other potential clients. "I think we will appeal to a wide range of both biotechnology and pharmaceutical companies because many now want to work within close proximity as the two industries merge. The Swedish Biotech Center is the ideal solution as it allows these companies to work alongside each other with a maximum of support." For more information on The Swedish BiotechCenter, contact Anne-May Engdahl. Nicholas Mead |
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