Pharma manufacturing news in brief

pharmafile | February 26, 2013 | News story | Manufacturing and Production Baxter International, Bone Therapeutic, DSM Pharmaceutical Products and Chemtrix, Sovereign Pharmaceutical 

Sovereign Pharma rapped by FDA, facility updates from Bone Therapeutics, Baxter and SHL, plus a continuous processing alliance between DSM and Chemtrix.

Sovereign Pharmaceutical of Dallas, Texas, has been sent a warning letter by the FDA for failing to investigate batch failures and not carrying out required in-process testing of its acetaminophen and hydrocodone bitartrate tablets. The company failed to conduct blend uniformity testing, arguing that this was not a Good Manufacturing Practice (GMP) requirement, but the FDA has taken a different view. Meanwhile, Sovereign has also been warned for manufacturing unapproved or misbranded over-the-counter drug products. 

Belgium’s Bone Therapeutics has made an equity investment in Skeletal Cell Therapy Support (SCTS), along with public and private investors – to help support construction of a €10 million manufacturing facility on the Gosselies Scientific Park near Brussels. The facility – which is scheduled for completion in 2015 – will be used to make Preob, Bone Therapeutics’ autologous bone cell therapy product that is currently in Phase III clinical trials for the treatment of osteonecrosis. 

Baxter International has embarked on an expansion of its cytotoxic contract manufacturing facility in Halle, Germany, with the addition of 1,750 sq. m. space to the facility. The new expansion plan will help the Halle plant support early phase drug formulation through commercial scale-up, product launch and lifecycle management. The expansion is expected to be completed by 2015 and increase the current workforce in Halle by around 10 per cent.

Drug delivery device specialist SHL is spending $40 million to expand manufacturing facilities in Taiwan in order to meet rising demand in the injectable biologic drug sector, particularly for auto injectors. The money will be spent on moulding capacity, materials handling and assembly functions, with the aim of boosting automation at the sites. SHL also said it would boost its headcount by around 700 from its current level of 2,200 staff in 2013.

DSM Pharmaceutical Products has teamed up with Netherlands-based chemical company Chemtrix, to provide equipment, development, and manufacturing services in the field of continuous flow chemistry to the pharmaceutical industry. Under the terms of the deal DSM and Chemtrix will offer process design, chemistry development, route scouting, equipment design and scale-up for fully continuous or integrated processes, to help clients develop sustainable manufacturing systems.

Phil Taylor

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