Wacker Chemie AG has expanded its biologics production facility, adding GMP manufacturing capacity and a process development building in response to customer demand.
Indian generic drugmaker Aurobindo Pharma officially launched its CRAMS unit AuroSource last week, also unveiling plans for an R&D facility in Pashamylaram near Hyderabad, India.
German contract manufacturing organisation (CMO) Excella will provide pneumatic dry granulation (PDG) tablet making services through a new partnership with Finnish specialty pharmaceutical firm Atacama Labs.
New Synthemax synthetic growth matrix promises improved scalability for large-scale hESC production which, say developers Geron and Corning, will cut cost of cell therapy manufacture.
A significant share of contract API maker ScinoPharm Taiwan is set to change hands after Watson Pharmaceuticals decided to sell its stake to Uni-President Enterprises Corporation.
Stratophase and GSK are part of a consortium developing a multi-parameter device capable of performing the real-time monitoring of key criteria needed to employ QbD in API production.
US FDA clearance for Italian antibiotics production facility is important for global growth says German contract development and manufacturing organisation (CDMO) Haupt Pharma.
SAFC Pharma is preparing for the shift towards cell culture-based vaccines, while still supplying and growing in the traditional sector, to ensure it can grow in coming years, according to a company director.
Changes to manufacturing practices at Genzyme’s plant have led to further shortages of Fabrazyme (agalsidase beta), with production expected to remain below 30 per cent of demand until after June 30.
The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
In the economic downturn biotechs have cut back on outsourcing to Asia and opted to use the US instead because they lack the resources to manage overseas relationships, according to a SOCMA representative.
Aesica is looking to acquire manufacturing assets in the US to expand its client base in the country and continue the growth it has maintained throughout the economic downturn.
Codexis’ enzymatic biocatalysis technology offers numerous processing and cost advantages for API and chemical intermediate manufacture says Dishman CRAMS unit president Nick Green.
There are signs that 2010 will be a better year for the fine and custom chemistry industry but companies at Informex remained cautious and are planning accordingly.
Contract API maker Ampac Fine chemicals (AFC) has had a busy 24-hours, entering the Japanese market through a deal with Inabata and forging an alliance with Codexis on biocatalyst technology.
Communication is a vital aspect of the relationship between CMOs, CROs and their clients, with a single point of contact who quickly informs sponsors of problems a necessity, according to a panel at Informex 2010.
Rusnano, the group set up to promote Russia’s nanotechnology infrastructure, says nanodrug development partnership will improve patient access and cut cancer death rates across the country.
Capsugel says latest addition to its Xcelodose range, Xcelolab, provides a rapid and reproducible solution for dispensing small amounts of pharmaceutical powders during laboratory stage drug development.
US CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.
Almac Pharma Services has bolstered its product development offering with a new Xcelodose 600s precision powder micro-dosing system that, it claims, can cut processing time, API usage and costs.
The US FDA says its new screening system will expedite the importation of genuine drugs and help inspectors focus their efforts on “high risk” products.
Almost half of antimalarials in Senegal are substandard, according to a USP study which will be used by local regulators to focus efforts on high-risk products, brands and geographies.
The EFCG has welcomed the addition of excipient GMP requirements to the draft amendments of the EU falsified medicines directive but warned that deeper analysis is needed to establish which products warrant further regulation.
Pall Life Sciences plans to shake up bioprocessing with a vibration-based filtering tech that can cut costs and simplify process design by combining harvest and clarification in the same system.
Full-year income at the Lonza was hit by falling demand for life science ingredients and custom manufacturing services and only modest gains for its bioscience unit.
Detection of Mycoplasma contamination in biologics manufacture can be cut from up to 35 days to four hours using Millipore’s MilliPROBE, according to the company.
Indian CRO Ankur Drugs and Pharma is a step closer to stating production of Romaco’s Siebler StripTabs now the German firm developed a fully integrated manufacturing line.
DSM Speciality Intermediates (DSI) is to close by the end of 2010, with activities at its production site ceasing in July, in response to pricing pressures caused by the rise of rivals in India and China.
Quotient Bioresearch has secured the supply of 14C labelled compounds for its customers ahead of its move to a new purpose built facility in Cardiff through an extension of its agreement with GE Healthcare (GEHC).
Johnson & Johnson (J&J) has expanded its US OTC drug recall after revealing that many more products than first thought may be contaminated by the wood dye, 2,4,6-tribromoanisole (TBA).
New Jersey, US-based contractors Catalent Pharma Solutions and Compass Pharma Services expanded their respective blister pack offerings last week, both citing growing drug industry demand.
SyberWorks is collaborating with the Validation and Compliance Institute (VCI) to provide FDA compliance training, including a programme covering cGMP production.
Pall says its acquisition of MicroReactor Technologies (MRT) broadens its offering in the $1bn (€689m) a year global biopharmaceutical process development market.
Genzyme has reported a small dip in preliminary fourth quarter and full year revenues, driven by declining sales of Cerezyme and Fabrazyme which have been affected by manufacturing problems.
