The Challenge of Change - Managing Excipients Control
Colorcon
| « Previous month | Next month » |
The future of Eli Lilly's API manufacturing facility in Lafayette, Indiana has been thrown into doubt by the news the company is considering selling it.
Affymetrix slumped to an operating loss in the second quarter of 2008, reporting flat revenues and blaming a 30 per cent reduction in sales to the pharmaceutical sector.
Robert Friel’s tenure as CEO of PerkinElmer continued its strong start with the firm reporting a 21 per cent increase in second quarter revenues compared to the same period last year.
US R&D organisation Draper Laboratory has unveiled plans to set up a new centre to develop and produce of its bioMEMS technology for therapeutic and healthcare applications.
In response to high customer demand, leading automated chemistry systems manufacturer Syrris is now offering to build custom-made laboratory reactor systems designed to meet individual customer needs.
Bio-Rad has published several application notes describing the use of its Profinity eXact protein expression system to obtain tag-free native proteins from a cell lysate in less than an hour.
FDA officials have impounded nearly $24m (€15.4m) worth of guaifenesin-containing timed-release (TR) cough and cold medicines made by US specialty drugmaker KV Pharmaceuticals.
in-PharmaTechnologist’s periodic round up of developments in the field of drug delivery includes BioDelivery initiating Phase I studies, success for Titan and a novel use for Viagra.
Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.
Lotus Pharmaceuticals' plans for a RNM 160m ($23.4m) manufacturing facility in Inner Mongolia mark another milestone in the Chinese firm's expansion on the global drugmaking stage.
Patients who took Roche’s antiviral Viracept (nelfinavir) from batches contaminated with ethyl mesilate do not have an increased risk of developing cancer, according to the EMEA.
Lotus Pharmaceuticals' plans for a RNM 160m ($23.4m) manufacturing facility in Inner Mongolia mark another milestone in the Chinese firm's expansion on the global drugmaking stage.
Vyteris has successfully completed a Phase I dose ranging study for its Smart Patch transdermal system for delivery of a peptide hormone.
Roche’s proposed $44bn acquisition of Genentech is facing some opposition with Wall Street saying the offer undervalues the company, disquiet among the biotech’s employees and shareholders suing the Swiss giant.
R&D integration specialist Symyx Technologies says its Powdernium Workstation is integral to the new automated dry powder dispensing system developed by a "major" but as yet unidentified pharmaceutical company.
in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of a fire at MY Healthcare, Helsinn's FDA approval and a safety award for Wyeth.
UK researchers have used the ReNcell VM stem cell line, licensed by Millipore from UK stem cell therapy experts ReNeuron, to model neural degeneration observed in Parkinson's disease.
Thermo Fisher Scientific has followed up its acquisition of Open Biosystems with the purchase of antibody experts Affinity BioReagents to further bolster its protein research offering.
US physicists have built the world's most sensitive 'nanomechanical mass spectrometer' that can accurately determine the mass of objects lighter than a single gold atom.
UK-headquartered ESA Biosciences has unveiled a new system for the identification of low levels organic impurities during the production of active pharmaceutical ingredients (API).
With fears of a global recession riding on the back of the credit crisis, many laboratory suppliers have managed to weather the storm and still achieve double digit sales growth in the second quarter of 2008.
Lonza of Switzerland is reaping the benefit of a shift away from bulk chemicals and towards custom manufacturing of high-value pharmaceuticals with a 13 per cent hike in sales in the first half of the year.
West African states are meeting to devise a plan for cleaning up their tarnished reputations with regards to the flow of counterfeit pharmaceuticals in the region.
Researchers from India and Japan claim to have developed a compact medical device capable of painlessly monitoring a patients insulin levels and administering the required dose.
The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.
The pace of change at GlaxoSmithKline (GSK) is showing no sign of slowing, with new CEO Andrew Witty unveiling the company’s new strategic direction with the release of second quarter results.
UK-headquartered ESA Biosciences has unveiled a new technique for the identification of low levels organic impurities during the production of active pharmaceutical ingredients (API).
US drug giant Merck & Co hopes that an additional $300m (€190m) investment in its vaccine manufacturing plant in Durham, North Carolina will cement its position at the forefront of the global vaccines market
In an ironic twist, researchers have shown that the tobacco plant, the cause of millions of cases of cancer, can be harnessed to produce personalised cancer vaccines.
Millipore, Purfresh and ESS Technologies have all recently launched products used in the pharmaceutical manufacturing industry.
Midas Pharma and Capsulution NanoScience have entered into a long-term cooperation agreement, with contract manufacturing capacity and other services being provided in exchange for access to drug delivery technology.
Contract packaging company International Labs has been taken over in a joint acquisition between India's Bilcare and MeadWestvaco of the US.
CMC ICOS, PharmEng, HollisterStier and RxElite are among the contract manufacturing organisations (CMOs) with news updates over the last few days.
Novartis’ extension of its collaboration with Alnylam Therapeutics and Roche’s acquisition of gene silencing specialist Mirus Bio Corp for $125m (€78.5m) suggest that big pharma is beginning to recognize the commercial potential of RNAi-based therapeutics.
Plastic packaging specialist China Bottles (CB) says that nearly two thirds of the $3.3m worth of contracts it signed in June were with pharmaceutical companies based outside its home territory.
Contract packaging company International Labs has been taken over in a joint acquisition between India’s Bilcare and MeadWestvaco of the US.
The heat is being turned up on Actavis Totowa as Federal lawsuits begin to pile up following the Digitek (digoxin) recall.
Brookwood Pharmaceuticals, a subsidiary of SurModics, has acquired the exclusive rights to all pharmaceutical applications of PharmaSol’s nanostructured lipid carrier (NLC) technology.
The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)
US software company Conformia hopes that its new web-based drug development suite will help pharmaceutical firms meet with new quality by design (QbD) and risk management guidelines.
There looks set to be further consolidation in the generics sector with Teva offering to acquire Barr Pharmaceuticals in a deal worth $7.5bn
A man has been sentenced in the US to four years imprisonment for trafficking 38,000 counterfeit Viagra (sildenafil citrate) tablets with a wholesale value of $400,000.
Bio-Rad has launched a new web-based search tool to give researchers easier access to its validated siLentMer gene silencing product line, which offers up to twice the silencing longevity.
Nanopoint has launched the 'world's most advanced' on-microscope cell containment device that offers complete environmental control for time-lapse cell imaging applications.
Thermo Fisher Scientific has integrated Genedata's Expressionist software with its high resolution mass spectrometry (MS) offering to enable high-throughput metabolomics data processing.
Scientists have completed the most comprehensive mammalian transcriptome analysis to date and believe the results should further our understanding of disease pathways.
Caliper Life Sciences has launched two new microfluidic-based electrophoresis instruments designed to address the separation needs of proteomic and genomic researchers.
Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company's share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.
A new excipient could help drugmakers improve the delivery profiles of active pharmaceutical ingredients (API), according to US developer Eastman Chemical.
With last month's launch of the Rhobust antibody capture system for MAb production applications, Upfront hopes to bring about a seismic shift in the MAb development paradigm.
3M Drug Delivery Systems believes it has made an advance in the administration of high potency therapeutics through the skin using its solid microstructured transdermal system (sMTS).
United Drug of Ireland said yesterday that it had signed a deal to acquire Sharp Corp, a contract pharmaceutical packager based in the US, for $99m.
German packaging giant Gerresheimer says that higher sales in both its plastics and tubular glass divisions helped boost its performance in the second quarter of 2008.
The new AccuSpray spray gun can reduce the amount of magnesium stearate that pharmaceutical firms require during drug manufacture, according to developer Oystar Manesty.
Modigene says that data from a trial of a Schering-Plough's (SP) fertility stimulation hormone (FSH-CTP) confirms that carboxyl terminal peptide (CTP) modification can extend the therapeutic duration of protein drugs.
The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives.
Lonza is to co-develop and manufacture Novartis' biological pipeline as part of a long term strategic partnership that has been struck between the companies.
The US Food and Drug Administration (FDA) is launching a quality-by-design (QbD) pilot programme for biotechnology submissions.
in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of Interlink's new Irish lab, Rentschler's biotechnology investment and GSK's plan to wind up operations at its Crawley plant.
Researchers from Germany's Fraunhofer Institute are using Affymetrix' assay technology to develop tests that detect drug induced liver injury (DILI).
Agilent has continued its summer spending spree with the acquisition of US-based Particle Sizing Systems that will further bolster the firm's Materials Science Services Unit (MSSU).
Avir Green Hills Biotechnology's intranasal vaccine deltaFLU for the treatment of pandemic influenza is commencing Phase I clinical trials.
PerkinElmer has created the ViaCord Research Institute (VRI) to investigate new uses of stem cells derived from umbilical cord blood.
Electron microscopy expert FEI has launched a new range of scanning electron microscopes (SEM) that enables sub-nanometre 3D surface imaging.
Sangamo Biosciences and Sigma-Aldrich have licensed their zinc finger nuclease (ZFN) technology to Roche to enable the pharma giant to develop cell lines and transgenic animals.
Bristol-Myers Squibb (BMS) has agreed to carry out a $3.7m upgrade of production facilities that are in breach of US Clean Air legislation (CAL), according to an Environmental Protection Agency (EPA) statement.
Vitro Diagnostics has opened a new facility for the development and manufacture of stem cell products for commercial application in the pharmaceutical industry.
in-PharmaTechnologist.com's periodic round-up of developments in the world of contact manufacturing includes a plant approval for PharmEng and new contracts for Akorn.
Electroporation specialist Inovio Biomedical Corp and vaccine developer VGX Pharmaceuticals believe that their recently announced merger will create a firm capable of rapidly moving DNA vaccine candidates from the laboratory to the clinic.
Japanese researchers have created a magnetic and mesoporous bioactive glass (MMBG), which combines a flexible drug loading mechanism with user targeted delivery.
Ark Therapeutics has bucked the trend towards outsourcing that currently dominates the drug industry with the establishment of its new €12.2m ($19.1m) commercial-scale production facility.
Praxair China has won the contract to supply the liquid nitrogen and cooling system for Jiangsu Defeng Pharmaceutical & Chemical's manufacturing plant.
The credit crunch is putting the squeeze on start-ups and established companies alike, with numerous firms struggling to obtain the financing that is their lifeblood.
US firm Althea Technologies and Protein'eXpert have teamed up to provide a broad array of biomanufacturing services, from protein engineering right through to commercial-scale production.
Poland urgently needs to take some of the red tape out of clinical trial applications if it is to fulfil its potential as a hub for clinical research, according to new market research.
The new guidelines for how monographs will be revised and elaborated to tackle potentially genotoxic impurities (PGIs) have been published by the European Pharmacopeia Commission.
A new Master Cell Bank (MCB) capable of producing pure cell culture for the manufacture of the anti-biofilm enzyme DispersinB represents a significant breakthrough, according to developer Kane Biotech.
GlaxoSmithKline (GSK) has sold four of its off-patent drug products to a South African drugmaker for £170m ($336m), describing the move as part of an ongoing effort to simplify its manufacturing operations.
New Mexico-headquartered drugmaker CytoDyn has begun the good manufacturing practice (GMP) standard production of the developmental candidate anti-HIV monoclonal antibody Cytolin (lymphocyte function-associated antigen-1).
Pharmaceutical manufacturers in Vietnam have gained a reprieve after the Ministry of Health (MoH) informed them that those without good manufacturing practice (GMP) certificates can continue production for now.
A deal to sell Pfizer's active pharmaceutical ingredient manufacturing (API) plant in County Cork, Ireland, has fallen through according to a statement by the US drug giant, placing over 180 production jobs under threat.
Senesco Technologies has signed a contract manufacturing deal for plasmids and a licensing agreement for a drug delivery technology as it seeks to get its Factor 5A treatment into clinical trials.
in-PharmaTechnologist's round-up of developments in the field of drug delivery, this week includes a report into protein delivery devices, a new insulin pump and a joint venture to improve block copolymers.
MDS Analytical Technologies has followed its acquisition of Molecular Devices last year by snapping up high content screening (HCS) experts Blueshift for $15m (€9.45m).
Agilent Technologies has continued its push into the materials science market with the acquisition of nanoindentation instrument manufacturer Nano Instruments.
Laboratory industry heavyweight, Thermo Fisher Scientific has acquired shRNA expert Open Biosystems to expand its gene silencing offering.
in-PharmaTechnologist.com's periodic round-up of developments in the field of pharmaceutical facilities includes news of two environmental fines, MHRA plant approval and a strike at Teva.
Biotechnology firm ProGen Pharmaceuticals has spun-out its manufacturing operations as the new wholly-owned subsidiary PharmaSynth.
The delivery of siRNA into cells has taken a step forward according to research published in the Journal of the American Chemical Society.
UK-based Sinclair Pharmaceuticals has entered into a manufacturing and distribution agreement with Wockhardt, an Indian pharmaceutical and biotech company.
Contract research and production specialist Patheon is to promote BSP Pharmaceuticals' cytotoxic development and manufacturing services as part of a marketing agreement that the two firms have signed.
Dutch sample and assay expert, Qiagen has bought Australia-based Corbett Life Science Pty in a deal that could be worth up to $135m (€86m).
High throughput (HT) screening expert Cisbio Bioassays and the Institute of Functional Genomics (IGF), Montpellier, have developed a method of analysing the receptor complexes that govern cell-cell communications.
Jade Pharmaceutical, a subsidiary of Californian drug firm AMDL, is to acquire privately-held China-based distribution specialist Sichuan ZhiTong Pharmaceutical (SZP).
in-PharmaTechnologist.com's periodic round-up of developments in pharmaceutical manufacturing equipment includes Mesa's real time monitoring, cleaning products and Beijer's new operating panel.
Vivalis has filed the biologics master file (BMF) with the US Food and Drug Administration for its EB66 vaccine and therapeutic protein production technology.
Californian pharmaceutical firm Aradigm has unveiled positive safety and efficacy data from an open-label study of its once daily inhaled liposomal antibiotic ciprofloxacin in patients with cystic fibrosis (CF).
in-PharmaTechnologist.com presents its periodic round-up of personnel changes in the pharmaceutical manufacturing sector.
Lonza has scored a contract manufacturing agreement from Osiris Therapeutics for its investigational adult stem cell therapy is building a new facility to support future business activities in this area.
Cobra Biomanufacturing has had a disappointing first six months of 2008, reporting an operating loss of $4.8m.
European technical services and industrial engineering specialist Imtech says it has received orders worth around €40m ($64m) from the Belgian operations of firms such as Janssen Pharmaceutica, GlaxoSmithKline (GSK) and Schering Plough.
Industrial spray and aerosol manufacturer Valois says that strong performance in its pharmaceutical division helped it off-set a hike in raw materials costs and have a successful 2007.
| « Previous month | Next month » |