Pharma manufacturing news in brief
pharmafile | October 14, 2010 | News story | Manufacturing and Production |Â Â Accucaps, Fresenius Kabi, ImmunoCellular Therapeutics, Laureate Pharma, SAFC PharmaÂ
This week’s round-up of pharmaceutical manufacturing news includes a recall for Fresenius Kabi, facility updates from SAFC and Laureate Pharma and new developments at Accucaps and ImmunoCellular Therapeutics.
Fresenius Kabi has issued a recall of two batches of its breast cancer drug anastrozole, shipped to the US and sold by subsidiary APP Pharmaceuticals, because of a cross-contamination issue at a manufacturing plant in India operated by Fresenius Kabi Oncology. Around 7,200 30-count bottles are included in the recall, according to a report in the Economic Times, which notes that traces of drugs other than anastrozole were found in some bottles.
US contract manufacturing organisation (CMO) Laureate Pharma has secured $20 million in funding to ‘relaunch’ the business. The money will be spent on a series of capital investments, including an upgrade to its aseptic fill capabilities, the launch of a new contract analytical business unit, the addition of cGMP cell banking services and the implementation of new quality systems. Laureate said it has boosted staff numbers by 10 and will add 50 more when the expansion is completed.
Sigma-Aldrich’s fine chemicals subsidiary SAFC says it has completed the expansion of its high-potency active pharmaceutical ingredient (HPAPI) manufacturing plant in Jerusalem, Israel. The 50,000 sq.ft. unit will start operations this month and produce secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. It also includes a Biosafety Level 2 area to allow it to handle human pathogens.
US biopharma company ImmunoCellular Therapeutics says it has developed a new method for manufacturing its autologous dendritic cell-based vaccine for the brain cancer glioblastoma multiforme, based on the use of a closed-bag system which generates dendritic cells from white blood cells collected from patients. Using the process, enough cells to generate up to 20 doses of the ICT-107 vaccine can be generated from a single donation, said the firm. Another company with a dendritic cell-based vaccine, Dendreon, has been struggling with manufacturing capacity issues since winning US approval for its Provenge product earlier this year.
Soft gelatine capsule specialist Accucaps Industries has set up a dedicated high-potency unit to tap into what it says is a fast-growing area of the drug delivery sector. The market for liquid filled soft gel formulated compounds is expanding due to the “increasing need to formulate high potency molecules that could not otherwise be provided in oral dose formulation”, says the Canadian firm.
Phil Taylor
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