Breaking News on Pharmaceutical Technology

Almost half of antimalarials in Senegal are substandard; study

09-Feb-2010 - 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.

EU revives GMP for excipients

08-Feb-2010 - 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.

Bioprocessing key to Millipore’s 2009 gains

03-Feb-2010 - Demand for disposable bioprocessing tech helped Millipore to a comfortable Q4, cementing the recovery made by the unit throughout 2009.

News in brief

Seidenader system detects pierced needle shields

03-Feb-2010 - Seidenader Maschinenbau has developed a system which can check up to 600 syringes per minute for pierced needle shields.

Pall launches PallSep Biotech for bioprocessing

03-Feb-2010 - 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.

Therapure rolls-out commercial scale lyophilisation service

01-Feb-2010 - Therapure Biopharma has added commercial-scale lyophilisation capacity at its facility Mississauga, Ontario in response to growing demand.

Millipore launches Mycoplasma early-detection system

26-Jan-2010 - 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.

J&J expands US OTC recall on more TBA contamination fears

19-Jan-2010 - 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).

VCI partners for cGMP e-learning

14-Jan-2010 - SyberWorks is collaborating with the Validation and Compliance Institute (VCI) to provide FDA compliance training, including a programme covering cGMP production.

Pall buys MRT for mini MTPD technology

13-Jan-2010 - Pall says its acquisition of MicroReactor Technologies (MRT) broadens its offering in the $1bn (€689m) a year global biopharmaceutical process development market.

Genzyme’s preliminary revenues dip

13-Jan-2010 - 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.

Millipore expands virus filtration range with Viresolve Pro

12-Jan-2010 - Millipore wants to help biopharmas address “virus safety challenges” and believes its new Viresolve Pro+ filtration system may provide the solution.

FDA advises on manufacturing MNPs during a pandemic

12-Jan-2010 - 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.

HK drug sector should raise GMP standards, report

07-Jan-2010 - 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.

News in brief

NIR can predict matrix pill dissolution; research

05-Jan-2010 - Cost savings and more consistency in the quality of pills could be realised if near-infrared spectroscopy (NIR) is used to predict dissolution rates of matrix tablets in the body, according to researchers.

Genzyme outsources to Hospira following in-house problems

05-Jan-2010 - 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.

News in brief

Teva extends Codexis biocatalyst deal

09-Dec-2009 - 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.

Mandatory overseas API inspections needed; ITRE

08-Dec-2009 - 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.

Dow forms independent protein production business

08-Dec-2009 - 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.

Genzyme ships Cerezyme again; Pfizer licenses Protalix’ rival

03-Dec-2009 - 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.

MEP questions figure used to justify not having mandatory inspections of API plants

02-Dec-2009 - 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”.

Sartorius launches single-use biomanufacturing range

02-Dec-2009 - 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.

Leeds Uni opens £4m process development lab

01-Dec-2009 - 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.”

Ranbaxy recalls Sotret in the US for second time

26-Nov-2009 - 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.