in-PharmaTechnologist.com's periodic round-up of developments in the pharmaceutical manufacturing space includes one production deal, news on India's API sector and an update on Jubilant's move to acquire Draxis.
SAFC to manufacture Reolysin Sigma-Aldrich's custom manufacturing unit, SAFC Pharma, is to conduct the manufacture of the development anticancer agent Reolysin on behalf of Canadian developer Oncolytics Biotech.
Reolysin is a proprietary formulation of the human reovirus that replicates preferentially in tumour cells bearing the Ras pathway, mutations in which are thought to play a role in two-thirds of all human cancers. SAFC will manufacture 40-litre batches of Reolysin at its site in Carlsbad, Germany, following its successful expansion of the 20-litre pilot scale manufacturing process. 40-litre yields are deemed sufficient to support Oncolytics' future development plans including both registration and the anticipated early stage commercial requirements. The Canadian firm added that work to support further scale-up to 100-litres batches is underway.
"Manufacturing at a commercial scale is an integral part of our development plans for Reolysin," said Dr. Matt Coffey, chief scientific officer of Oncolytics. "We have built a solid relationship with SAFC Pharma through numerous projects ranging from media optimization to scale up efforts, and we are very pleased to be working with an international leader with a proven track record in biologic manufacturing," he added. FDA OK for Tonira plant
Indian active pharmaceutical ingredient manufacturer Tonira Pharma has received US Food and Drug Administration (FDA) approval for its manufacturing facility in Vadodara, Gujarat. The firm said that FDA clearance will enable it to export drugs made at the unit to customers in the USA. Around 60 per cent of Tonira's business comes from the antirheumatic, antiseptic and antidepressant segments, of which exports account for 90 per cent. At present the company exports to Korea, Brazil, Japan, France and Pakistan.
Recently, Mumbai-based Ipca Laboratories has acquired controlling stake in Tonira, increasing the 14 per cent holding it acquired in 2007 to around 36 per cent. Neuland Labs plans to invest in API business
Indian contract manufacturing and API production specialist Neuland Laboratories plans to invest $400m in the development of its contract and clinical research services in the next few years. Neuland said that it is seeking to establish a presence in a diverse range of therapeutic areas, excluding oncology, for customers based in North America and Europe. The firm said that it will use the additional investment to increase its manufacturing and development capacity.
Neuland's chairman and managing director, Dr DR Rao, said: ``Our objective is to become an end-to-end service provider for the pharmaceutical industry. From our current capabilities of API manufacturing and contract research services, we want to expand our capabilities into areas of clinical research and subsequently other areas of drug discovery support services such as formulation development, pre-clinical research, bioanalytical studies.'' Rao added that: ''By mid-2008, we may look at new opportunities in drug discovery support, and also look at building another manufacturing facility.''
Draxis shareholders approve Jubilant deal Canada's Draxis Health reports that its shareholders have approved plans to sell the company to Indian custom research and manufacturing services (CRAMS) to Jubilant Organosys. Around 99 per cent voted in favour of the move; way above the 66 per cent threshold that was required.
The plan of arrangement, when it becomes effective, will result in the acquisition of all the outstanding shares at a cash value of $6 each. The closing of the transaction is subject to customary closing conditions including the receipt of final clearance from the Qubec Superior Court, which is expected to consider the case on Tuesday May 27.
In recent years Jubilant has been actively expanding its global operations, most notably in April last year when it purchased Washington-based contract manufacturing group Hollister-Stier Laboratories for $122.5m.