Pharma manufacturing news in brief

pharmafile | October 16, 2012 | News story | Manufacturing and Production |  Applikon Biotechnology, Ark Therapeutics, Encap Drug Delivery, Recipharm, Symbiosis 

Ark wins contract to make gene therapy, Encap starts hot melt extrusion project, plus updates from Reciharm, Symbiosis and Applikon Biotech.

UK contract manufacturing organisation (CMO) Ark Therapeutics has won a contract from Finnish drug developer Laurantis Pharma to manufacture and supply Lymfactin, an adenoviral vector-based gene therapy for breast cancer associated lymphedema that is expected to start Phase I testing next year. Breast cancer-associated lymphedema is the most common form of secondary lymphedema, occurring in approximately 20% of breast cancer patients who undergo axillary lymph node dissection.

Scotland-based Encap Drug Delivery has forged an alliance with Queen’s University in Belfast, Northern Ireland, to develop new capabilities in hot melt extrusion (HME), a technology first applied in plastics but latterly used to prepare various types of dosage forms and drug delivery systems. HME dosage forms are mixtures of active ingredients, excipients and processing aids and have the advantage of requiring no solvents in their preparation as well as simpler processing steps. In some cases they may also result in increased bioavailability compared to doses made by traditional pharmaceutical processing techniques. “We are confident that we can establish and grow HME as a mainstream technology for poorly soluble molecules,” said Encap.

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Contract manufacturing organisation (CMO) Recipharm has won a contract from fellow Swedish company Astimex Pharma for formulation development work on an undisclosed drug candidate, with the possibility of expanding the collaboration into manufacturing. Astimex is also in discussions with Recipharm on a number of other manufacturing and development projects, said the firms. Set up in 2007, Astimex sells and distributes drugs in the Nordic region but to date has not taken any in-house products through development.

Symbiosis Pharmaceutical Services of Scotland says it has officially opened its new sterile drug manufacturing facility for clinical trial drug supply, following the issuance of a manufacturing license by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The small-scale, 6,300 sq. ft. facility in Stirling specialises in fill/finish manufacturing of sterile liquid, lyophilised, conventional, cytotoxic and biological drugs.

Bioreactor systems manufacturer Applikon Biotechnology has started building a new development and manufacturing facility in Delft, the Netherlands, that it says will help it target the ‘international biopharmaceutical industry’. The 3,700 sq. m. building will house offices, laboratories, a workshop and warehouse and accommodate approximately 100 workers.

Phil Taylor

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