Breaking News on Pharmaceutical Technology

ICH publishes Q&A on Q8, Q9 and Q10

03-Jun-2009 - The ICH has published a question and answer (Q&A) document to clarify some of the common issues encountered by pharma companies implementing Q8, Q9 and Q10 guidelines.

Sparta brings pharma quality management to Asia

02-Jun-2009 - Sparta Systems is establishing operations in Hong Kong as part of efforts to expand in Asia-Pacific (APAC), where it believes there is a growing market for quality and compliance management.

Upfront boasts 60% yield boost in processing step

25-May-2009 - CMO Richter-Helm BioLogics has achieved a 60 per cent increase in yield using technology from Upfront Chromatography, which demonstrated its system at BIO 2009.

Peru lab gains drug quality accreditation

25-May-2009 - Peru’s National Center for Quality Control (CNCC) has attained ISO/IEC 17025:2005 accreditation, furthering its safety efforts and becoming one of the few Latin American countries to achieve this.

Mutiple parameters are key to powder analysis, says Freeman

18-May-2009 - Freeman Technologies, which showcased its FT4 Rheometer at Achema in Frankfurt, Germany, last week, says pharmaceutical powders are complex systems that require analysis of multiple parameters.

Orbital bioreactors set to shake up mammalian cell culture sector

13-May-2009 - ExcellGene’s OrbShake 250L mammalian cell culture bioreactor has equalled biomass productivity and oxygenation levels previously only achieved by traditional stirred tank systems.

News in brief

Millipore launches single-use ChromaSorb

07-May-2009 - Millipore has launched its single-use ChromaSorb membrane adsorber, which binds negative impurities from host cell protein (HCP), DNA, endotoxins, and viruses at high salt concentrations.

Cooler aims to boost nebuliser testing accuracy

06-May-2009 - Copley Scientific is expanding its range of nebuliser testing equipment by launching its NGI Cooler, which has been developed in light of suggested revisions to aerosol monographs on both sides of the Atlantic.

GEA probe helps companies follow PAT initiatives

29-Apr-2009 - GEA Pharma Systems’ process equipment is now available with its Lighthouse Probe technology, which uses fibre optics and mirrors to give a clear view of the product when it is in the machine.

SAFC and Vivalis launch high yield EB66 media

28-Apr-2009 - SAFC and Vivalis have launched a new media designed to allow the latter’s commonly used virus producing EB66 cell line to grow at higher cell densities and produce higher yields.

Millipore’s deal to improve influenza vaccine purification

27-Apr-2009 - Millipore is collaborating with Microbix Biosystems to improve influenza vaccine manufacturing by developing a purification process using novel chromatographic technology.

China ramps up stem cell efforts just weeks after US research U-turn

23-Apr-2009 - Construction of a new stem cell research and processing plant began yesterday in China’s Eastern Jiangsu province as part of a joint project between the Chinese government and Shenzen Beike Biotechnology.

News in brief

EQDM suspends 4 APIs made in China

23-Apr-2009 - Last week the EDQM suspended the certificates of suitability of four APIs manufactured in China, adding to the one in March that sparked the recall of 14 products in Spain.

Aoxing’s pain drug plant gets GMP OK

21-Apr-2009 - China Aoxing Pharmaceutical, a specialist developer of pain management drugs, has received GMP accreditation for the new tablet production and packaging plant it has set up in Shijiazhuang.

Polestar launches sensor for disposable reactors

20-Apr-2009 - Polestar Technologies has launched its iDOT single-use pH and dissolved oxygen sensor, which can be welded into the walls of disposable reactors to provide in situ process monitoring.

bioMerieux launches “groundbreaking” MFT medias

17-Apr-2009 - French diagnostics and microbiology firm bioMerieux claims its new range of indicator medias will help drugmakers cut testing times and reduce errors during GMP mandated sterility analysis.

ASEAN GMP audit sharing a step to EU-like single market

15-Apr-2009 - The Association of Southeast Asia Nations’ (ASEAN) member states will recognise each others GMP certificates as part of a programme intended to raise standards and eliminate trade barriers.

FDA issues final guidance on ICH Q10

08-Apr-2009 - The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle.

Compliance initiatives increase despite economy; survey

08-Apr-2009 - Companies are maintaining their spending on quality control measures despite the challenging operating environment, according to Matthew Kopecky, product manager at Sparta Systems.

Asia-Pacific manufacturing growth attracts Werum

07-Apr-2009 - Werum Software & Systems has set up offices in Japan and Singapore, which will strengthen its position in Asia-Pacific and help it meet the region’s growing demand for tools to improve manufacturing quality.

Alliance launches animal-free culture supplement

06-Apr-2009 - Novozymes and Millipore have launched an animal-free culture supplement, which has been designed to reduce risk and regulatory pressures in upstream biopharmaceutical processes.

ProMetic sees improvement despite economic climate

01-Apr-2009 - Protein technology and therapeutic specialist ProMetic managed to increase revenues in 2008, despite the challenging economic climate, but still posted a net loss of CN$20.2m (€12.1m).

Bayer’s engineering affiliate opens up in India

01-Apr-2009 - Bayer Technology Services GmbH, an affiliate of Germany's Bayer, has opened its first regional office in India, enlarging its presence in the fast-growing Asian markets.

ESS’ Taskmate adds robotics to tube filling and closing

01-Apr-2009 - ESS Technologies’ says its unique robotic loading system improves the speed, efficiency and accuracy of pharmaceutical manufacturers’ tube filling and closing operations.