The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.
The incoming Xcellerex CEO plans to move the company from validation to penetration, boosting revenues and client base, and invest in the contract manufacturing side of the business.
Delegates lucky enough to have made the trip to Interphex 2010 in New York, US bore witness to the launch of a wide range of new drug manufacturing technologies with products by O'Hara, Corning and PTI being some of the highlights.
Microfluidics chose Interphex 2010 in New York, US to unveil a new processing technology that it claims can help manufacturers save time and money by switching from batch to continuous particle production.
Syntagon is implementing a strategic pricing initiative to give “substantial cost savings” to pharma and biotech companies taking compounds into Phase I and II clinical trials.
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”.
ATMI is using Interphex 2010 to launch the Integrity PadReactor, a disposable bioreactor designed to provide a highly scalable entry point in its line of mixing and process manufacturing systems.
Ajinomoto AminoScience has launched AjiPhase, a peptide synthesis service which makes it practical and efficient to produce and scale up products that were previously considered too complex.
Demand in “Pharmerging” markets will offset declining revenues from off-patent blockbusters and drive prescription drug sales to $1.1tr (€819bn) by 2014, according to IMS Health.
Baxter’s BioPharma Solutions unit has expanded its manufacturing facility in Halle, Germany, adding capacity to meet clients’ demand for large-scale production of cytotoxics.
“Good business development” in the pharma and “slow spending” in the cyclical cosmetics and life sciences sectors dominated Gerreshimer’s performance in the first quarter of 2010.
Contract manufacturing organisation (CMO) Patheon has installed new soft gel manufacturing capacity at its facility in Cincinnati in response to “an unmet customer need.”
Rising use of biologics and a tax initiative will drive the streamlining of Indian supply chains, helping companies to deliver drugs at affordable prices, according to PwC.
US delivery specialist Penwest is to apply its Timerx tech to “complex” generic pharmaceuticals in a development and commercialisation pact with non-branded drugmaker Alvogen.
The drug industry will gain new options for sterile contract development and manufacturing in the near future with DPT Laboratories, NextPharma and Vetter each working on new dedicated units.
Avid Bioservices and Halozyme Therapeutics have expanded their relationship, adding manufacturing agreements and designating the CMO as a preferred supplier.
Hyde Engineering + Consulting has opened an office in Dublin, Ireland, enhancing its ability to provide Europe-based biopharm with compliance, qualification and automation services.
The market for “nano-enabled” pharmaceutical packaging is growing 16.5 per cent a year and will be worth $8.1bn (€6bn) by 2014 according to new research by iRAP.
The WHO has published its views on the production of starting materials in draft guidance which details recommendations to ensure product quality while keeping costs down.
The European Medicines Agency (EMA) has recommended a recall of Acino’s generic Plavix (clopidogrel bisulfate) because of alleged failings in GMP at the API production facility.
Thermo Fisher Scientific will take charge of clinical trial material production at Eli Lilly’s research technology facility in Indianapolis as the pharmaceutical firm further reduces in-house capacity to cut costs.
Access to Millipore’s UCOE expression technology though a new partnership is “step change” for customers, says contract manufacturing organization (CMO) Eden Biodesign.
Contract manufacturing organization (CMO) ScinoPharm says strong anticancer API sales and growing demand in Europe and Asia were key to record performance in 2009.
The IPEA's issuance of good manufacturing practice (GMP) “certification” is mark of manufacturing quality, says US specialty chemicals supplier W R Grace & Co.
IRL and Epichem have entered into a strategic alliance to provide the Australasian pharma market with services from drug discovery through to cGMP production.
GSK has confirmed that material from the PCV1 virus has been detected in Rotarix and, although there is no evidence of a safety risk, the FDA has recommended use is temporarily suspended.
New specialist development and manufacturing “centres of excellence” increase efficiencies and customer access to expertise, DPT Laboratories spokesman tells Outsourcing-pharma.
Industrial filtration specialist Pall and testing firm Sotax say their new co-marketing deal is only first stage of planned pharmaceutical industry certification solutions partnership.
Millipore has expanded its microbial detection offering with Milliflex Quantum which, it says, enables manufacturers to respond to contamination issues earlier in the drug and vaccine production process.
The Botswanan government is seeking to initiate local pharma manufacturing, which would lower drug prices, by entering into public-private partnerships (PPP), according to a report by F&S.
CEO Steffen Mittwich updates in-PharmaTechnologist on Atacama Labs' pneumatic dry granulation (PDG) API processing tech, its deal with German CMO Excella and future development plans.
Prosonix’ new UMAX particle engineering technology is set to “revolutionise” the field of respiratory medicines, according to company CEO David Hipkiss.
US drugmaker Genzyme has detected an impurity in one vial of the Gaucher’s disease drug Cerezyme produced at its manufacturing facility in Waterford, Ireland.
Patheon attributes Q1 loss to charges and plant closure costs and says there has been “an encouraging increase in new sales activity” in calendar 2010.
GSK, Genentech, BIO and PDA have stated that it is “unnecessarily burdensome” for pandemic production plans to conform to parts of 21 CFR and requested that the FDA revises its draft guidance.
Indian CMO Bilcare says need to test new drugs in diverse patient groups drove expansion of its cold chain clinical trial supply packaging and storage facility in Crickhowell, Wales.
The Chinese government is supporting a $100m (€73m) project to build a contract biologics production facility in Beijing, which, by some measures, would be the largest in Asia.
Glycos Biotechnologies has produced lactic acid in a pilot plant using its sustainable technique, successfully scaling up from a laboratory setting to provide an alternate source for the chiral synthon.
Cambridge Major Laboratories (CML), Avantium, Xcelience and Beckloff have formed a consortium to offer tailored, client-focused CMC packages which are particularly suited to atypical compounds.