Pharma manufacturing news in brief
pharmafile | May 29, 2012 | News story | Manufacturing and Production |Â Â Adienne Pharma & Biotech, Hospira, Neuroptis Biotech, Provence Technologies, Selexis and Florida Biologix, baxterÂ
Hospira overfilled Carpuject cartridges, high-potency certification at Baxter, plus updates from Provence Technologies, Selexis and Florida Biologix.
The FDA has issued an alert to health professionals after discovering that Carpuject pre-filled cartridges – sold by Hospira – may be overfilled by at least twice the expected amount, raising the risk of overdose. The agency said it stopped short of a recall because pharmacists and other healthcare providers should be able to visually detect the overfilled cartridges, and it is concerned that a recall could lead to a shortage of the medicine. Carpuject is a painkiller medication based on morphine and hydromorphone.
Baxter International‘s high-potency manufacturing facilities in Halle and Bielefeld, Germany, have been certified by independent auditor SafeBridge Consultants to handle both parenteral drug substance synthesis and parenteral drug product manufacturing and testing. Baxter claims it is the only company in the world certified at this level. The facilities support Baxter’s contract manufacturing unit Baxter BioPharma Solutions. Last year, Baxter said it was ramping up production capacity at Halle to cope with increasing demand for cytotoxic manufacturing.
French biopharma company Neuroptis Biotech has partnered with fine chemistry specialist Provence Technologies for the production of GMP supplies of ML7, a drug in development at Neuroptis as a treatment for dry eye syndrome. Provence and Neuroptis have already collaborated successfully in developing a synthetic pathway for ML7, manufacturing the first non-GMP batches, and devising associated analytical methods. The compound is scheduled to start clinical trials this year.
Italy’s Adienne Pharma & Biotech has asked Selexis of Switzerland to develop a manufacturing cell line for one of its pipeline drugs. Adienne specialises in orphan drug development, and has three drugs in its development pipeline, namely Begedina for graft-versus-host disease, Mubodina for atypical haemolytic uremic syndrome (HUS) associated with an inherited abnormality of the complement system, and Ergidina for the prevention of ischaemia reperfusion injury after solid organ transplantation. The company has not disclosed which compound is the subject of the Selexis agreement.
US contract development and manufacturing organisation Florida Biologix says it has produced, purified and tested a clinical batch of novel gene therapy for aromatic amino acid decarboxylase deficiency (AADC), that was used in a Phase I trial conducted by Taiwan University Hospital. AADC is an extremely rare genetic disease that affects the brain’s ability to produce the neurotransmitters dopamine and serotonin. Results of the trial have been published in Science Translational Medicine (16 May edition).
Phil Taylor
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