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Aseptic Technologies has recently signed two major deals for the development of its Crystal technology.
The first one is a partnership signed with NextPharma Technologies, a Contract Manufacturing Organization (CMO) active mainly in Europe and USA. NextPharma will offer the Crystal technology to its clients by leveraging the filling facility of Aseptic Technologies, installed in Belgium.
The second one has been signed with a major European biotech to develop the lyophilization solution of the Crystal technology. Aseptic Technologies will further develop the lyophilization process by using the products of this company as model.
1) NextPharma Technologies Enters Partnership Agreement with Aseptic Technologies
Surrey, UK, 17th September, 2008 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotech industry, is pleased to announce that it has entered into a partnership agreement with Aseptic Technologies to manufacture sterile products using a new ‘closed vial’ technology.
Under this agreement NextPharma will sub-contract the filling of vials to Aseptic Technologies (at their site near to Brussels) for those NextPharma customers wishing to access this new technology – which involves the aseptic filling of vials, based on a completely closed system and using pre-sterilised plastic vials. NextPharma will continue to provide other services, including overall project management, directly to its customers.
Bill Wedlake, CEO, NextPharma Technologies, commented: ‘We are delighted to have reached this agreement with Aseptic Technologies which enables us to enhance further the service we provide for our customers enabling them to access this new technology through NextPharma.’
Patrick Balériaux, Managing Director, Aseptic Technologies, commented: “This collaboration with NextPharma is a real opportunity for Aseptic Technologies to offer direct access to the revolutionary Crystal Closed Vial Technology to a broad base of pharmaceutical and biotech companies”.
For more information, the complete press release content is available at the end of this newsletter
2) Lyophilization development with Crystal technology
The second partnership deal aims to develop lyophilization of pharmaceutical drugs in the CrystalÒ technology.
The lyophilization process is based on the concept that water evacuation will be carried through the piercing trace made by the needle. To that end, the trace is re-opened with a device, the penetrator. This penetrator has a funnel shape and is moved down by the shelves of the lyophilization equipment, as a result, the piercing trace is sufficiently re-opened to allow lyophilization.
The first development results have shown:
· Lyophilization in the closed vial is obtained with identical cycles compared to glass vials, using complex excipients
· The penetrator re-opens sufficiently and effectively the piercing trace to allow lyophilization
· The stopper comes back in initial position at the end of the cycle, being ready for laser re-sealing and capping
· Lyophilization of viruses results in recoveries similar to glass vial recoveries, showing that there are no more negative impact on sensitive products compared to glass
· Lyophilization at mid-scale (720 vials together) is feasible with enough strength in shelves and heat exchange process.
The main objectives of this deal are:
· Show with a biotechnology product that the Crystal technology is suitable for lyophilization up to industrial scale
· Finalize development of the current technology to ensure that the solution meets all requirements from the authorities to approve a drug for commercialization.
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