The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.
US CMO Affinity Life Sciences has completed the expansion of its manufacturing plant, adding capacity for cGMP lyophilisation and biomarker development.
Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles of 2010.
ProJect Pharmaceutics has opened its Munich headquarters and laboratory facilities in Martinsreid, Germany, beginning business operations to transform proteins, peptides and small molecules into novel drugs.
The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
US CDMO DPT Laboratories has received FDA approval to make commercial supplies of a wound ointment at its sterile and specialty products plant in Lakewood, New Jersey.
West Pharmaceutical Services will close a plant in Pennsylvania, US and sell part of a factory Cornwall in the UK to reorganise production operations ahead of impending contract expiries.
The McCrone Group says pharmaceutical industry need for “quick and dirty” QA/QC solutions in the laboratory and on the factory floor is driving growth of the market for bench-top microscopy.
Lanxess has opened an ion exchange resin production facility in India to cater for growing pharmaceutical manufacturing sector demand for ultrapure water.
Drafting ICH M7 guidance on genotoxic impurities will require a lot of work from industry and regulators but has the potential to resolve a number of issues.
US Contract research laboratory Metrics reveals that benzophenone, a component used in varnish on labels, is able to migrate through HDPE bottles to reach the pills inside.
bioMérieux will discontinue manufacturing media products for clinical applications and transfer production of other products made at its Portland, US, site elsewhere as part of a restructuring program.
Counterfeit ACT could support the spread of drug resistant malaria strains from South-East Asia, where chloroquine first became ineffective, to sub-Saharan Africa.
India-headquartered pharmaceutical packaging manufacturer Bilcare has rolled out a new unit, Bilcare Research, which merges its existing films and foil businesses with those of recent acquisition Ineous Films.
Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.
Performing environmental testing early in a molecule’s development and including data in tech transfers to CMOs helps ensure there is little mass loading from pilot and commercial plants.
UK drugmaker, GlaxoSmithKline and Moscow-based JSC Binnopharm have formed a deal that will see the latter produce GSK’s cervical cancer, rotavirus and pneumococcal vaccines in Russia.
Narrowly defined pharma self-interest and lack of coordinated political effort means, despite the best effort of some, the problem of counterfeiting may be worsening.
Aluminium lakes and in-liner packaging can, in some cases, be used to control reactive components in excipients and therefore overcome drug product instability.
Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.
The knowledge and means are in place to implement real-time release (RTR), a PAT pioneer said at AAPS, but questions remain about whether pharma has the will and desire.
Johnson & Johnson’s McNeil unit has initiated another recall, this time involving 4m packs of Children’s Benadryl allergy tablets and around 800,000 bottles of junior-strength Motrin caplets.
SCM Pharma says demand for specialised contract manufacturing services is growing as the pharma industry focuses on niche indications, biologics and the development of potent medicines.
Johnson & Johnson and Millennium Pharmaceuticals have recalled several thousand vials of the anti-cancer drug, Velcade following reports of white particles floating in the medicine.
Newly-formed Gateway Analytical is confident its service offering, employees’ experience and ties to its parent company will allow it to grow despite a challenging operating environment.
German pharmaceutical giant Merck's life science division, EMD Millipore, has launched its 'single-use' Mobius 3L CellReady Bioreactor, for use in the development and optimisation of cell culture processes.
Agilent Technologies has launched its 708-DS Dissolution Apparatus, a quality control instrument that can be set up for manual or automated applications to measure the release rate of an API over time.
Combatting counterfeit drugs through forging stronger partnerships is beyond profit, it is about saving lives, AstraZeneca principal scientist Dr Michael Claybourn told a workshop on global drug quality at the AAPS annual meeting in New Orleans.
The USP is building a database of counterfeit essential medicines to support international drug procurement organisations, such as WHO, and the timely sharing of information between national regulators.
Crucell and Eden Biodesign have entered into an agreement that sees Eden become a provider of services of contract manufacturing services for Crucell's PER.C6 cell-line technology.
The European Medicines Agency (EMA) says 12-month API plant joint inspection programme has fostered greater collaboration between international drug industry regulators and cut the number of duplicate visits.
API maker AMRI cited arbitration costs, efforts to address a US FDA warning letter and acquisitions as key factors in Q3 loss, but predicted that large-scale contract manufacturing business will drive final quarter gains.
In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
Volunteer organisation, the Blue Bird Circle will provide grants of $1m to Texas Children’s Hospital in the US for the establishment of a new clinical research centre.
