Continuing production of medically necessary products (MNPs) in the event of a pandemic will be made easier by developing a contingency plan, according to the FDA which has issued guidance on the subject.
A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.
The Hong Kong pharma sector should aim to adopt current World Health Organisation (WHO) GMP standards for drug manufacture within two years, according to a new report.
Laureate Pharma and Selexis SA have entered into a joint-marketing relationship, drawing on their respective strengths in contract manufacturing and cell line development to shorten timelines.
The US Department of Justice (DOJ) has given partial approval for Amcor’s takeover of Alcan after announcing it would now limit its review to Alcan’s Medical Flexible operations.
Genzyme is outsourcing fill and finish manufacturing of several major drugs to Hospira in response to in-house difficulties at its Allston Landing facility in Boston, Massachusetts, US.
Rexam will close its pill and tablet bottle making facility in New Hampshire, US by the end of the year to further align global plastics operations according to new CEO Graham Chipchase
Patheon says a slowdown in “outsourcing decision making,” manufacturing problems in Puerto Rico and cost related to JLL’s takeover bid hurt it in fiscal 09.
US formulation services provider Bend Research says a new safety file for the bioavailability enhancing drug excipient, HPMCAS, can now be referenced by its clients in FDA filings.
Canadian CMO Patheon will consolidate its Puerto Rican activities at its facility in Manati and sell or close its plant in neighbouring Caguas by 2011.
CMO Avid Bioservices’ year-on-year revenues increased by 440 per cent in the second quarter, leading to the company planning expansions in Asia-Pacific, biosimilars and analytical services.
Teva will continue to use Codexis’ biocatalysis technology for key processing steps in the production of four generic drugs under a revised agreement announced last week.
Dow has joined with Signet Healthcare Partners to form a new independent company which will use the chemical company’s Pfenex protein expression technology to accelerate development.
Repeated mandatory inspection of overseas API facilities should be performed to prevent falsified products entering the EU, according to a committee which has published proposed amendments to the draft directive.
CDMO Haupt Pharma has invested in a combined heat and power unit (CPHU) for its site in Wolfratshausen, Germany, which is now expected to produce 14 per cent less CO2 a year.
Pfizer and Protalix have increased the pressure on Genzyme by signing a new accord to commercialise Uplyso (taliglucerase alfa), a potential rival to its Gaucher’s disease treatment Cerezyme, just days after the US biotech resumed production.
CMO Vetter Pharma has expanded its manufacturing capacity with a new in Illinois, US that it says brings it closer to customers and will allow it to collaborate with clients earlier in the drug development process.
Indian API maker Avon Organics’ share price rocketed 10 per cent on the Bombay exchange yesterday after the US launch of a generic herpes treatment by Ranbaxy Laboratories.
Sartorius Stedim Biotech has introduced FlexAct BP, the first product in a range which will be an integrated single-use system for entire biomanufacturing steps in upstream and downstream processing.
A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
Leeds University in the UK has unveiled a new £4m (€4.4m) laboratory designed to make small-scale process development “greener, cheaper and more effective.”
Patheon and JLL are to end the legal actions between them by entering into a litigation settlement which establishes a board of directors and limits JLL acquiring additional restricted voting shares before April 27 2012.
Indian drugmaker Ranbaxy Laboratories has withdrawn stocks of its acne drug Sotret in the US for the second time this year after some tablets were found to be out of specification.
SAFC Biosciences hopes Ex-Cell Antifoam, its new foam control product for cell culture bioreactors, will work the biomanufacturing sector into a lather.
The recent wave of M&A will lead to manufacturing over-capacity at pharma companies but only a small number of these sites will be sold to CMOs, in part because of the facilities’ suboptimal locations, according to a report.
The market for contract manufacturing organisations (CMO) will be worth $33.7bn (€22.4bn) by 2014, according to a report which says developing biologics capabilities is a key imperative for growth.
PX'Therapeutics SA, formerly called Protein'eXpert, has set up an additional biomanufacturing unit dedicated to producing therapeutic proteins and monoclonal antibodies in mammalian cells.
Millipore has acquired the remaining 60 per cent of its Indian joint venture (JV) to drive growth in the country which it views, along with the other BRICS nations, as a critical part of its strategy.
GEA Pharma Systems has extended its agency agreement with India’s Ace Technologies to include its range of lyophil freeze-dryers in a bid to further open up the market.
Continued high demand for vaccine manufacturing technologies saw life sciences emerge as one of the few positives for industrial processing specialist Pall in Q1.
UK process technologies firm Reaxa has received a £146K (€164K) R&D grant from the Northwest Regional Development Agency (NWDA) to scale-up production of its EnCat nickel catalyst.
US contract manufacturing organisation (CMO) Catalent’s packaging facility in Dublin, Ireland has achieved ISO 15378:2006 under the ISO’s quality scheme.
WuXi PharmaTech’s operating income increased by 35 per cent in the third quarter, underpinned by strong growth in China-based laboratory services, but its manufacturing operations continue to struggle.
Lonza is manufacturing GlaxoSmithKline’s (GSK) and Genmab’s antibody Arzerra (ofatumumab), which was recently approved by the FDA, under a long-term supply deal.
Dow has used AAPS 2009 to launch an updated, digital version of its Keys to Chelation compilation, which allows to industry reference standard to be used more effectively, according to the company.
French drug delivery specialist Galenix has named DSM’s pharmaceutical products unit as its manufacturing and co-marketing partner as it continues to efforts build its global presence.
US contract polymer maker Delivery Science has ramped up its formulation and analytical testing offering in a partnership with the University of Rhode Island’s (URI) College of Pharmacy.
Genmab has put its Brooklyn Park, Minnesota, US facility up for sale, which will reduce its headcount by 300, and plans to use CMOs to cover for the loss of capacity.
Particulate Systems (PS) and Surface Measurement Systems (SMS) have entered into a strategic collaboration drawing on their knowledge of using analytic equipment for the characterisation of particulate, porous and complex materials.
West Pharmaceutical Services is laying off 100 staff as part of restructuring efforts after its third quarter results fell short of expectations, despite operating profit increasing by 45 per cent.
Welsh contract services firm Penn Pharmaceuticals has reorganised its transport and delivery infrastructure in the first phase of a £12m (€13.3m) expansion at its facility in Tredegar.
O’Hara Technologies has launched a lab-scale tablet coating system that incorporates a blender and tray dry oven inserts to cut capital expense and GMP spaced needed perform these tasks.
