Breaking News on Pharmaceutical Technology

Phone-based anti-counterfeiting proposed for developing world

27-Aug-2009 - Researchers have presented a low cost track and trace and authentication system, which they believe could be implemented immediately, to combat counterfeiting in the developing world.

News in brief

GEA shipping systems to Chinese business

24-Aug-2009 - GEA Lyophil has won a contract to supply €15m ($21.5m) worth of pharmaceutical freeze dryers with automatic load and unload systems (ALUS) to a Chinese manufacturer.

GEA wins €15m order from China’s Hisun Pharmaceutical

20-Aug-2009 - GEA Lyophil, part of GEA Pharma Systems, has won a contract to supply Chinjese drugmaker Zheijang Hisun Pharmaceutical with freeze drying systems and automatic loading units.

News in brief

Barr recalls batch of oversized ADHD drug

18-Aug-2009 - Barr Laboratories has recalled a single batch of the drug detroamphetamine/ amphetamine, used to treat attention-deficit hyperactivity disorder (ADHD) after tests revealed that some tablets exceeded weight requirements.

Sani-Tech tubing could be boost for bio

12-Aug-2009 - Biotech processes will be improved by using Sani-Tech Ultra tubing, according to its manufacturer that claims the product has a longer lifespan and lower concentration of extractables than its competitors.

Downstream demand helps Millipore’s Q2

10-Aug-2009 - Demand for downstream processing products from biotechs drove the continued recovery of Millipore’s bioprocessing division in Q2 but operating income remained flat.

Lilly to train Russian FDA

04-Aug-2009 - Eli Lilly is among the organisations partnering to provide training for the Rozdravnadzor, Russia’s equivalent of the FDA, which is seeking to improve its knowledge of manufacturing standards.

Genzyme hit with $8bn lawsuit

30-Jul-2009 - Shareholders have filed an $8bn (€5.7bn) lawsuit against Genzyme alleging that the company’s CEO “issued a series of materially false and misleading statements” about its manufacturing problems.

Mylan & FDA appear to disagree on QC inquiry

29-Jul-2009 - Mylan and the FDA appear to be in disagreement about whether investigations into quality controls at a US facility are ongoing, with both releasing seemingly contradictory statements.

Mallinckrodt pulls “subpotent” Cr-51 batch

13-Jul-2009 - Mallinckrodt Pharmaceuticals has recalled one batch of its sodium chromate Cr-51 diagnostic agent after FDA post-marketing tests revealed that some of the products were “subpotent.”

News in brief

Esco launches new Pharmacon Downflow sampling booths

08-Jul-2009 - Singapore-based Industrial cleanroom and containment specialist Esco Micro has rolled out the latest generation of its Pharmacon Downflow booths for pharmaceutical sampling, grinding, dispensing and filling operations.

ISO 9001 accreditation a “huge step” for Prosonix

07-Jul-2009 - Ultrasonic particle engineering specialist Prosonix has been accredited under the ISO 9001:2008 quality scheme, after an inspection by the UK unit of independent auditing group SGS.

USP revises monographs to tackle contamination

06-Jul-2009 - The USP is revising monographs of four pharmaceutical excipients in light of hazards associated with diethylene glycol contamination and is seeking comments from interested parties.

TFS and Siemens hope to have process analysis down PAT

01-Jul-2009 - US group Thermo Fisher Scientific and industrial engineering giant Siemens have teamed up to offer the pharmaceutical industry a new way of assessing processes used during early drug development, manufacturing scale up and commercial production.

PSI collaborates with Microfluidics

01-Jul-2009 - Particle Sciences (PSI) is aiming to advance its contract processing offering by collaborating with Microfluidics and sharing formulation and nanotechnology expertise.

Caraco products seized by FDA

29-Jun-2009 - US Marshals have seized products from Caraco’s facilities in Michigan because of concerns over cGMP compliance, which has led to Sun Pharma withdrawing its financial guidance.

KV completes investigation; admits deficiencies

25-Jun-2009 - KV Pharmaceutical found deficiencies and instances of noncompliance during its internal investigation, which was launched in response to issues with the FDA and allegations of management misconduct.

Sanyo claims H202 steralised incubator is industry first

25-Jun-2009 - Sanyo Biomedical and Environmental Solutions claims the H202 steralisation approach used by its Steisonic CxP MCO-19AIC(UVH) cell incubator system is an industry first and effective replacement for ethylene oxide (EtO).

Millipore’s Massachusetts Mobius plant open for business

22-Jun-2009 - Millipore has ramped up capacity for its Mobius range of single use bio-processing and manufacturing technologies with a new purpose built production facility in Danvers, Massachusetts.

Sanofi uses SCM for radiolabelled production

15-Jun-2009 - Sanofi-Aventis is using SCM Pharma’s aseptic fill/finish service for radiolabelled compounds to manufacture an oncology product that is in clinical trials.

Alfa hopes to make industrial chemistry an ART

11-Jun-2009 - Sweden’s Alfa Laval says ART PR49, its combined chemical reactor and heat transfer plate, improves the efficiency of chemical production and helps reduce energy costs.

FDA revises ICH Q8 guidance

10-Jun-2009 - The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

Mocon launches Pac Check 650 EC for small headspace analysis

04-Jun-2009 - US Instrument specialist Mocon has launched Pac Check 650 EC, a packaging headspace analyser that, it says, can help pharma manufacturers find the right oxygen/carbon dioxide balance to support shelf life and drug efficacy goals.

Genomatica forwards sustainable BDO

03-Jun-2009 - Genomatica claims it can process 1,4-butanediol (BDO), a precursor in pharmaceutical production, with 99 per cent purity from renewable feedstocks, removing the need to rely on crude oil.