The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.
SGS Life Sciences will expand bioanalytical capacity at its facility in Poitiers, France in the latest stage of its effort to become the biggest biologics testing services firm by 2014.
Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.
Johnson & Johnson and Millennium Pharmaceuticals have recalled several thousand vials of the anti-cancer drug, Velcade following reports of white particles floating in the medicine.
Newly-formed Gateway Analytical is confident its service offering, employees’ experience and ties to its parent company will allow it to grow despite a challenging operating environment.
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
SGS Life Sciences will roll out new biologics testing capabilities across its network in bid to be the world’s number one contract biopharmaceuticals testing laboratory by 2014.
AMRI recorded a $6.0m (€4.6m) operating loss in the second quarter as restructuring charges and the lack of milestone payments offset contract service gains.
Contract research organisation (CRO) Diteba Research Labs says partnership with fellow Canadian-based Thesis Chemistry reflects increasing customer demand for API and intermediate synthesis.
Concerns about the quality and capabilities of Baxter’s manufacturing operations have led to Halozyme issuing a notice of breach and stating it may terminate their Hylenex relationship.
Norwich Pharmaceuticals is expanding beyond its traditional manufacturing focus by launching a CRO in India to provide clients, and its parent company Alvogen, with clinical research services.
Lonza has reported stronger demand in the first quarter, but volatility remains in the custom manufacturing sector and it is uncertain if improvements “represent true and full economic recovery”.
MLawGroup and WS Partners are collaborating to offer pharma and biotech advisory services, including help in preparing and negotiating agreements with CROs and CMOs.
Hyde Engineering + Consulting has opened an office in Dublin, Ireland, enhancing its ability to provide Europe-based biopharm with compliance, qualification and automation services.
Australia-based CRO TetraQ is doubling throughput of trial samples, resulting in a 30 per cent time saving for clients, by installing a Spark Symbiosis system at its site in Brisbane.
WuXi PharmaTech posted an operating profit of $52m (€38m) in 2009 and is optimistic about 2010, when it will make investments in laboratory services and large-scale manufacturing to drive growth in coming years.
US CRO PPD has been busy on both sides of the Atlantic, opening a clinical testing facility in Ireland and, in the US, moving forward with plans to spin-off its compound partnering business as Furiex Pharmaceuticals
Almac Clinical Services says novel temperature monitoring system speeds shipping and cuts quarantine times by allowing authorised personnel to make decisions on trial supplies at clinical sites 24/7.
Consolidation in pharma, coupled to the trend for strategic partnerships, will lead to CRO mergers, with large companies getting bigger and small firms focusing on niche opportunities, according to a report.
MDS has agreed to sell its Pharma Services division, with a CRO and private investors lined up to buy different sites, but approximately 275 employees will lose their jobs during the transition.
Microbiology testing company Nelson Laboratories has completed its 50,000 sq ft expansion and estimated it will create as many as 300 jobs over the next decade, with up to 100 appointments being made this year.
Latin America, new services and mid-sized pharma clients are targets for the incoming CEO of Clearstone Central Laboratories, who set out his vision for the business in an interview with Outsourcing-Pharma.
The Nucleotide Research Complex, the largest such facility in the Middle East, is now operational and ready to house companies’ research and development, analytical, diagnostic and equipment training activities.
US CRO Pacific Biometrics is to be renamed Pacific Biomarkers, after shareholders voted in favour of the change at the company’s AGM earlier this month.
US software firm Instem will establish an office in Shanghai, China, to provide customer support, client management, development and sales support to its Chinese pharmaceutical and life sciences R&D clients.
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.
Preclinical drug testing specialist Absorption Systems has branched out and opened a new surgical lab designed to help pharmaceutical firms assess the safety of biomaterials and medical devices.
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”.
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.
Icon is looking to expand its bioanalytical capacity in Asia, notably in China, and bolster its genomics, proteomics and cell-based assay capabilities, according to a VP who discussed diversification of the business.
PPD’s acquisition of Merck’s vaccine testing laboratory will give it a geographic location from which it can compete for business with its “number one competitor”, which is well established in the north east of the US.
the exponential growth of data points flowing into clinical study databases. As technologies help researchers to reach more patients all over the world,...
Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...
