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News in brief

Avacta lands top 10 US pharma buyer for Optim platform

07-Jun-2011 - Analytical technology firm Avacta says it has won its first top ten US pharma customer in collaboration with marketing partner Pall Life Sciences.

Xcellerex wins new customers for manufacturing techs

06-Jun-2011 - Biomanufacturing technology firm Xcellerex has had a good start to June with R-Pharm and Fujifilm Diosynth signing up as customers.

News in brief

China arrests 263 in counterfeiting crackdown

31-May-2011 - Chinese authorities have arrested hundreds of people accused of manufacturing and selling fake pharmaceuticals in the country’s Zhejiang province.

EU falsified meds act formally adopted

31-May-2011 - The European Union (EU) formally adopted the falsified medicines directive at the weekend, giving member states 18 months to makes the document's anti-counterfeiting track and trace measures into national law.

News in brief

US FDA launches facility inspection database

30-May-2011 - The US Food and Drug Administration (FDA) has published a list of all the drug manufacturing facilities it has inspected between October 2008 and September 2010 as part of Government transparency efforts.

cGMP warning letter round up

24-May-2011 - in-PharmaTechnologist presents a round up of current good manufacturing practice (cGMP) related warning letters sent by the FDA in recent months.

FDA oversight of J&J in Puerto Rico is “deeply troubling”

24-May-2011 - Fears the US FDA is mismanaging oversight of J&J in Puerto Rico are “deeply troubling”, said a US Congressman.

JV offers modular plant design to cut construction times

23-May-2011 - A global joint venture has been formed to cut biopharm facility construction times by using modular plant designs.

EU revises API certification doc to clarify appeal policy

19-May-2011 - The EDQM has revised its policy on withdrawal of API or excipient certification to clarify the appeal process.

update

GEA Pharma Systems unveils ConsiGma-1 lab-scale continuous granulator

17-May-2011 - Processing technology specialist, GEA Pharma Systems, has introduced the ConsiGma-1, a lab-scale continuous granulator.

Unilife’s Q3 revenues slide as Sanofi milestones end

17-May-2011 - Syringe maker Unilife saw its revenue fall in the third quarter on a lack of milestone payments and its exit from the contract manufacturing sector.

News in brief

Codexis completes biocatalyst tech transfer to Teva

17-May-2011 - Codexis has completed technology transfer of custom biocatalysts to Teva, leading to their use in pilot plants and commercial scale production.

PBS Biotech launches PBS 3 single-use Bioreactor system

16-May-2011 - Californian Bioreactor manufacturer, PBS Biotech, has launched its new PBS 3 single-use bioreactor system for the development of biological therapeutics, vaccines and biosimilars.

EMD opens Shanghai biopharma training plant

12-May-2011 - EMD Millipore has opened a training facility in China as an education resource for the country’s rapidly expanding biopharmaceutical manufacturing and development sector.

Codexis’ drug intermediate sales up in Q1; net loss deepens on R&D

12-May-2011 - Pharmaceutical intermediate sales helped Codexis in Q1 but the US biocatalysis specialist still posted a net loss for the quarter on higher R&D spending

Production quality control issues drag on Teva Q1 sales

12-May-2011 - Quality issues slowed first quarter revenue growth at Teva but, with one plant resuming shipping and another awaiting re-inspection, sales are expected to pick up.

News in brief

SSB launches small-scale disposable reactor

12-May-2011 - Sartorius Stedim Biotech (SSB) has launched a new small-scale bioreactor citing growing biopharmaceutical company demand for scale-up technologies as the key driver for its development.

FDA & USP extend relationship to modernise drug quality

10-May-2011 - The FDA and USP have expanded their collaboration to ensure the quality of medicines by modernising tests and standards.

Indian Carbogen plant meets HPAPI handling standards

09-May-2011 - Carbogen Amcis’s Indian plant has met industrial standards for the containment and handling of highly potent active pharmaceutical ingredients (HPAPI).

News in brief

American Reagent to resume production at NY plant

09-May-2011 - American Reagent is to resume production at its New York, US plant after investigating cases of glass delamination.

Aptuit producing fast-dissolve nanoparticles in Ph III deal

05-May-2011 - Aptuit is manufacturing Phase III materials for Iroko using a nanoformulation technology that produces fast-dissolving particles.

Prosonix and Sterling complete API commercialisation

04-May-2011 - Prosonix and Italian partner Sterling have completed the commercialisation of a respiratory active pharmaceutical ingredient (API) using the UK firm’s unique particle engineering technology.

News in brief

Grifols to sell assets to clear way for Talecris takeover

02-May-2011 - Grifols is to sell a facility as part of a US FTC consent agreement that, if approved, will allow it to buy Talecris Biotherapeutics.

Spinning disc reactors – a revolution for chemical production say researchers

02-May-2011 - Scientists at Eindhoven’s University of Technology (TU/e) say their new ‘spinning disc reactor’ increases the safety and efficiency of chemical production processes.

Teva resumes production at Irvine, CA facility

27-Apr-2011 - Teva has resumed production at its Irvine, California plant a year after quality control issues put production on hold.

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