Pharma manufacturing news in brief
pharmafile | September 7, 2010 | News story | Manufacturing and Production |Â Â Aegis Protek, Alexion, Halozyme, Ranbaxy, SemBioSysÂ
A round-up of pharma manufacturing developments from Ranbaxy, SemBioSys, Halozyme, Aegis Protek, Alexion and Thomson/Rondaxe.
Ranbaxy Laboratories of India has opened a $30 million manufacturing facility at Roodepoort in South Africa that will manufacture analgesics, cold, cough and flu preparations, antihistamines and various other medicines. The plant – operating as Be-Tabs Pharmaceuticals Manufacturing – is Ranbaxy’s third in Africa. It will have an output capacity of 1.75 billion tablets and capsules and 2 billion packs a year.
Canada’s SemBioSys Genetics has been awarded a key US patent (No. 7,786,352) covering the use of genetically-modified plants to produce apolipoproteins, including Apo AI (Milano). The company is developing a business based on transgenic production of biosimilar and novel drugs. Apo AI (Milano) is being evaluated for its potential as a treatment for atherosclerosis.
Halozyme Therapeutics has completed its investigation into manufacturing compliance issues affecting its Hylenex (hyaluronidase) product for paediatric rehydration and is gearing up to present a corrective action plan and market re-launch strategy to FDA. The company issued a recall of the product in May after discovering flakes of a glass like material in vials of the product, which is finished by contract manufacturing partner Baxter.
A novel excipient developed by Aegis Protek called dodecyl maltoside could help reduce the formation of neutralising antibodies in multiple sclerosis patients treated with recombinant beta interferon, according to a study published in the Journal of Neuroimmune Pharmacology. Neutralising antibody responses can significantly reduce the effectiveness of interferon therapy in MS patients.
US regulator the FDA has given a green light to Alexion Pharmaceuticals’ production plant in Rhode Island, USA, giving the company a second production source for its Soliris (eculizumab), indicated for treatment of the rare blood disorder paroxysmal nocturnal haemoglobinuria (PNH). Alexion has also hired Swiss contract manufacturer Lonza to make the drug, which was first introduced in 2007.
Thomson Reuters and Rondaxe have teamed up to develop a tool to help generic manufacturers calculate the cost of manufacturing active pharmaceutical ingredients (APIs). Under the terms of the arrangement, patent and synthesis route data from Thomson Reuters will be combined with leading cost-of-goods modelling tools from Rondaxe. “Information on the costs associated with manufacturing APIs is vital for generic drug companies and API manufacturers around the world, which operate in an intensely price competitive market,” said the two partners.
Phil Taylor
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