The Challenge of Change - Managing Excipients Control
Colorcon
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A multinational, multidisciplinary initiative involving scientists, public health workers, police and government officials could provide a cogent model for rooting out and stamping out counterfeiting of essential and lifesaving drugs.
UK specialty pharmaceutical company Glide Pharma has signed a deal with a "leading" pharmaceutical company, under which the as yet unidentified firm will evaluate Glide's Solid Dose Injection system for the administration of one of it range of branded peptide therapeutics.
AMRI edged back into the red during the fourth quarter of 2007 after stagnant sales growth and higher costs, a scenario that is expected to continue.
French scientists have found a suitable genetic variation of mice that can be used to study the way the Chikungunya virus develops and spreads in the human body.
The state of Massachusetts should invest become the 'new medicine capital' of the US, with a focus on translational medicine research, or risk losing out to rivals around the world.
The spiraling cost of developing a new drug, which organisations such as the USA-based Tufts Centre for the Study of Drug Development estimate to be between $800m and $1.2bn, means that companies wishing to create innovative medications face ever growing financial risk.
Bayer Healthcare is to deploy a new technique, developed by Millipore, for genetically engineering cells to produce pharmaceutically useful proteins that could both increase the yield and accelerate drug production.
Bosch Packaging Technology will be rolling out a range of new and recently launched processing and packaging solutions at the Interpack 2008 exhibition in Düsseldorf, Germany this April, including a new line for high-potency compounds.
Novartis has lent impetus to the growing trend towards philanthropic R&D in the pharmaceutical industry by opening a new research institute in Siena, Italy "with a non-profit mission to exclusively focus on the development of vaccines for diseases of the developing world".
Sigma-Aldrich has struck a deal with Atlas Antibodies that grants it distribution rights to Atlas' library of 1,800 antibodies that is expected to grow by several thousand per year.
The prospect of Europe's very own institute of technology - dubbed the European equivalent of MIT - is looking increasingly likely.
A new consortium in Scotland is to develop a new 3D cell assay for use in drug discovery and for safety evaluation prior to clinical trials, in the hope of cutting costs and reducing the use of animals for testing.
West Pharmaceutical Services has reported sales of over $1bn in 2007 and is optimistic about 2008, despite a small drop in the consolidated gross profit margin large in Q4.
Packaging giant Gerresheimer crowned its first year as a public company with a leap in profits for the fourth quarter of 2007, helped by its acquisition of plastic specialist Wilden Group.
LabTechnologist presents its periodic round-up of new product introductions in the life sciences arena, with releases from Invitrogen, Genetix, Vapourtec and GE Healthcare.
Oil price fluctuations had the expected impact of dampening profits in H&R Wasag's key chemical-pharmaceutical raw materials business during 2007.
Biotage has announced plans to shift its business focus to the environmental analysis sector - an industry on the rise as soaring world population demands more efficient and safe laboratory technologies to deal with waste, hazardous materials and cleaning.
An investigation in the aftermath of a fire and explosion at one of Cambrex' US plants last year has found the firm in breach of several safety regulations and the company will be fined accordingly.
Jubilant Organosys, India's largest custom research and manufacturing services (CRAMS) provider, has scored new contracts to the tune of $92m for the year thus far as its business continues to gather momentum.
A tool that more quickly identifies proteins present in cancer cells and identifies targets for immunological therapies and diagnostics has been reported by Austrian researchers.
Earnings growth from its pharma solutions business helped push BASF's operating income (EBITDA) from fine chemicals up by 56.5 per cent to €288m in 2007.
Genmab, the Danish antibody specialist with three product candidates in Phase III clinical trials, is taking control of its manufacturing requirements with the agreed acquisition of an antibody facility in Minnesota, US for $240m in cash.
Accu-Break Pharmaceuticals (ABP), the US company with a suite of tableting technologies for creating divisible dosage forms, has signed a co-operation agreement with Germany's Midas Pharma that should open new avenues for technology licensing and ABP products in Europe.
Dextra Laboratories, Akorn, Metrics and Xcelience have all recently announced new contract manufacturing news.
A protein discovery that could open up a whole new pathway for drug development has been reported by scientists from the University of North Carolina at Chapel Hill in the US.
Germany's rap.ID Particle Systems has launched a new lab-ready particle identification device capable of identifying around 400 particles an hour from 5µm and up. The company says the device is suited for development and quality assurance in the pharmaceutical industry.
Scientists can now transform adult cells to a stem cell-like state without using a cancer inducing gene. Researchers at Harvard University said they can now map the stages of the reprogramming which had thus far been a mystery.
Denmark's Novozymes has renewed and extended its collaboration with UK-based biotech Upperton Limited on a drug delivery system that exploits the natural binding properties of recombinant protein nanoparticles to improve compound targeting and bioavailability.
A new laboratory technology that uses a genome sequencer system has discovered a new virus that is thought to be responsible for the deaths of three transplant recipients.
Australian bio-nanotech company pSivida has received the first R&D payment of $500,000 from pharmaceutical giants Pfizer for pSivida's controlled drug delivery technologies in ophthalmic applications.
More details have emerged over the US Food and Drug Administration's (FDA's) failure to vet the Chinese manufacturing plant implicated in the Baxter heparin scare - the agency mistook it for an already-inspected plant, it turns out.
Cambrex' cost cutting resolve is starting to pay off for the firm, who achieved an improved profitability in the fourth quarter of 2007, although sales are still stagnant.
A nanoparticle-based delivery system is being developed in the UK as a potential means of bypassing the blood brain barrier and improve the treatment of central nervous system diseases such as brain cancer.
Generic drug manufacturer Vintage Pharmaceuticals has fallen foul of the regulatory authorities in the US once again for failing to meet quality standards.
Concerns have been building across North America about the safety of transdermal patches for delivering the highly potent narcotic analgesic fentanyl.
A new recombinant pig liver esterase (PLE) biocatalyst that sidesteps concerns about the safety of animal-derived versions has been launched by DSM Pharma Chemicals.
With 40-60 per cent of a global drug manufacturing industry worth more than $380bn captured by the North American marketplace, the region offers sustained opportunities for suppliers of pharmaceutical water and wastewater treatment solutions to increase their revenues while improving market share and brand recognition.
Aceto, the US-based distributor and marketer of fine and industrial chemicals, is making a determined pitch for the pharmaceutical intermediates sector in Japan.
A new 'map' that depicts the interactions between proteins from pathogens and humans could help explain how viruses and bacteria manage to trick victim cells into carrying out their dirty work.
West Pharmaceutical Services has formally announced the end of its Exubera relationship with the product's developers Nektar Therapeutics.
A lab on a chip method has been developed to mimic brain chemistry and so give a greater understanding of how neurons in the brain interact in the formation of a nervous system.
The UK's Applied Cytometry is gearing up to launch a new ultra high-speed software system for data analysis/processing in applications generating large data sets such as laser flow cytometry.
A novel delivery system that converts the structure of cartilage "from a barrier into a reservoir" could provide an answer to the challenge of administering and maintaining drugs in avascular tissue.
Agilent Technologies report a 20 per cent drop in its first quarter profit as a healthy revenue growth is offset by restructuring, higher stock-based compensation costs and other expenses.
Fourth quarter operating profit at Italian packaging automation firm IMA SpA fell some 8.5 per cent to €27m, while its revenue for the period declined 4.2 per cent to €147m, although pharma sales, buoyed by acquisitions, kept its full-year figures in positive territory.
A cross-agency agreement that should ease reliance on laboratory animals in testing for environmental toxins and generate data more relevant to humans has been signed by the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA) in the US.
The first European approval application for a vaccine delivered via a new intradermal (ID) microinjection system developed by BD (Becton, Dickinson & Company) has been filed by Sanofi-Pasteur, the vaccines division of the Sanofi-Aventis group.
Qiagen announced strong Q4 results and good overall growth for 2007, despite going through significant integration and acquisition efforts. The firm also gave guidance for a 40 per cent growth rate in 2008.
An end may be in sight to the long-running problems with the Florida manufacturing facility acquired by US brand and generic company Watson Pharmaceuticals with Andrx Corporation in November 2006.
A leading medical research council has called for increased funding within the European medical research community to maintain high standards and attract and retain the brightest young researchers.
Novo Nordisk and Merck & Co have both indicated they have their eye on expanding their drug discovery and manufacturing presence in India and forging new research partnerships among companies in the country.
Researchers at the Broad Institute of MIT and Harvard, USA, have successfully employed a new technique developed by Agilent that could potentially eliminate one of the biggest bottlenecks in the genetic sequencing process.
Questions are hanging over the role of a Chinese manufacturing facility in the Baxter heparin scare after it has emerged that the US Food and Drug Administration (FDA) has never inspected the facility.
Sigma-Aldrich has reported record annual revenues of $2.04bn in 2007, fuelled by strong growth in life science products and fine chemicals, favourable exchange rates and a $60m acquisition.
UK drug delivery specialist SkyePharma has signed an agreement with India's Dr Reddy's Laboratories for a feasibility study of an unnamed product using two of SkyePharma's proprietary drug delivery systems.
A Phase II clinical trial using French company Polyplus-transfection's innovative gene delivery tool, in vivo-jetPEI, is set to go ahead this month in Europe and the US.
Copapharm Europe, the pan-European alliance of pharmaceutical packagers, has significantly raised its game in the Spanish market with a new member, Artes Graficas Nekar.
The US Food and Drug Administration (FDA) has once again been accused of failing in its duty to protect the American public.
The European Commission is unlikely to support an outright ban on the use of non-human primates in research, but has just published a new document which indicates that significant changes to current legislation are envisioned.
Baxter International has suspended the production of its blood-thinning drug heparin in multi-dose vials, following the deaths of four patients in the USA who were given the drug in high doses.
Continued strong global demand for oral tablet formulations helped drive a robust performance by FMC BioPolymer in the fourth quarter of 2007.
In the fight against tuberculosis in Africa a group from Massachusetts Institute of Technology has invented a smart electromechanical pill box designed to help patients comply with their treatment.
Researchers have created a transparent adult zebrafish that will allow scientists to observe disease processes in a laboratory environment and may explain the cancer life cycle and why its cells migrate to other parts of the body.
For the first time, US scientists have found a way of simultaneously performing optical and electrical measurements on the same single molecule, known as multimodal sensing.
Pfizer's announcement of plans to create a new €130m inhaled medicines unit at its facility in Amboise, France suggests that the firm is still intent on investing in inhalation technology, despite its disappointment with Exubera.
DSM, Althea, Laureate Pharma, Albemarle and Patheon have all recently announced new contract manufacturing news.
The threat of intimidation, harrassment and violence by animal extremist goups has prompted new recommendations detailing measures scientific institutions can take to protect laboratory researchers.
Scientists have made use of a new method for analysing gene expression to interrogate the whole genome for the causes of familial combined hyperlipidemia - an inherited disease that can contribute to high cholesterol and early heart attacks.
After several years, Invitrogen and Agilent have at last settled patent infringement court cases concerning tools used in complementary DNA synthesis, polymerase chain reaction (PCR) and other molecular biology applications.
The green tea polyphenol (-)-epicatechin-3-gallate (ECG) may slash the risk of gastric cancer among women by 75 per cent, suggests a new study from Japan.
Germany's Geneart, a specialist in synthetic biology, is expecting strong growth in 2008 on the back of strong demand for gene synthesis.
Beckman Coulter saw its fourth quarter earnings held back by the cost of acquiring NexGen Diagnostics, but the underlying business was strong with a near-11 per cent hike in revenues.
Mole Genetics has launched its low cost, benchtop personal DNA extraction/purification system to the European market.
A new study has demonstrated for the first that microneedle technology is able to overcome some of the barriers preventing the transdermal administration of drugs with low bioavailability.
Four of India's biggest vaccine manufacturers have had their licenses suspended by the Indian government after failing to meet good manufacturing practise (GMP) requirements, according to local media reports.
Several contract manufacturers have recently made announcements regarding updates to their facilities.
A proposed rule on labelling changes published by the Food and Drug Administration (FDA) has re-ignited the reliably inflammable debate over the role of pre-emption in US product liability cases.
A tattoo you may not end up regretting could be one that provides a more efficient means of delivering DNA vaccines through the skin.
A new process for synthesising anti-inflammatory drugs such as ibuprofen could offer an environmentally friendly means of avoiding the 50 per cent waste seen with current methods of synthesis.
New York-based AMRI has added to its Indian operations, following the acquisition of another manufacturing plant in the country.
Cook Pharmica has announced an $80m expansion to its biopharmaceutical facility in Bloomington, Indiana.
Germany put in a strong showing as category winners were announced for the fourth annual Facility of the Year Awards (FOYA) recognising innovation in pharmaceutical manufacturing projects.
Russian scientists have created a device that determines micro- and nano-particle size using a laser technology that claims to be more accurate than methods currently used in the laboratory and could find a role in pharmaceutical quality control.
Artel has introduced a new feature for its Multichannel Verification System (MVS), which includes an automation function that allows for time savings and reducing human error.
Alpharma has signed a definitive agreement with private equity group 3i for the sale of its active pharmaceutical ingredient (API) business, pocketing $395m in the deal to reinvest in its pharmaceutical and animal health divisions.
NMR (nuclear magnetic resonance)/MRI (magnetic resonance imaging) is a fairly mature technology but has limited sensitivity at the micro-scale, holding back its usefulness for analysing catalytic reactors and reactions in microfluidic devices.
A new £2m chemical engineering laboratory at the University of Strathclyde in the UK will spearhead an expansion of its activities in biomolecular engineering, with a particular focus on human health, nutrition and finding new ways to generate energy.
Biomatrica has launched the RNAstable - a piece of kit that preserves RNA samples at ambient and elevated temperatures with minimal degradation.
Spirax Sarco Engineering, the UK-based group focused on systems for the use and control of steam and industrial fluids, is boosting its activities in the biopharmaceuticals sector through the acquisition of Denmark's Flexicon A/S for DKK 141m (€18.9m).
With increasing pressures on pharma pipelines leading to greater interest in compound licensing, firms can be caught out by failing to give scalability issues due attention, according to Joseph D'Antuono speaking at last week's Informex trade show in New Orleans.
Integrated DNA Technologies (IDT) has launched LabLinker, a free online system for sharing genome sequence data and even share shipping costs of orders.
German pharmaceutical packaging group Gerresheimer has once again extended its reach in the plastic packaging space, this time acquiring Allplas Embalagens, the market leader for pharmaceutical plastic packaging in Brazil.
UK contract research specialist Molecular Profiles has introduced a suite of analytical techniques, collectively known as nanoPASS, that promises to help pharmaceutical scientists come up with the best formulations for their products.
Cellexus Biosystems, the UK company that designs, manufactures and sells disposable cell growth technology for the biopharmaceutical industry, is extending the rental plan offered on its CellMaker Lite2 single-use bioreactor in response to significant demand since the plan was introduced last September.
Q Chip, Solvay Pharmaceuticals, Richman Chemical, Nastech and Altus Pharmaceuticals have all had people on the move in the world of pharmaceutical manufacturing.
Despite adverse publicity in the past, the UK public is becoming increasingly supportive of using human tissues in medical research, according to a new study.
Delft Technology University (TU Delft) in the Netherlands, has decided to create a new bionanoscience department in a clear indication of what it feels is one of the key up and coming scientific fields.
GE Healthcare has agreed to purchase UK laboratory equipment maker Whatman for £363m ($718m) in a move aimed at advancing GE's life sciences business.
LabTechnologist takes a final pick of new and updated equipment that formed the LabAutomation exhibition's showcase. Much of the technology featured was shown to the public for the first time.
Chemicals firm SAFC plans to avoid the backlash that could be on its way as the pharma industry continues to struggle in an ever-challenging environment, reducing its reliance on sector in a bid to maintain its position in the market.
Researchers can now reduce the cost and time taken to breed goats that can produce therapeutic proteins using gene therapy. Experts say these transgenic animals could cut the cost of insulin and other cancer-fighting proteins.
A new technique that analyses the structural characteristics, and not the sequence, of DNA has revealed previously unknown areas of the human genetic code responsible for gene expression.
The Spanish subsidiary of UK-based biological nanoparticles specialist Midatech Group has signed a licence agreement giving it new leeway to exploit the therapeutic potential of noble metal nanoparticles.
Chinese outsourcing firm Radiant Pharma & Tech is blasting through the stereotypes being pinned on companies operating in low-cost economies, with the relatively young firm hoping to give companies in established markets a run for their money.
A delegation from the Scotland's chemicals industry descended on the recent Informex trade show in New Orleans, determined to convince the assembled industry representatives that the country should be at the top of the list for firms seeking out a competitive location for their business.
US biotech Neose Technologies has dropped its lead compound, NE-180, a PEGylated form of erythropoietin, from development, saying concerns over the safety of erythropoiesis-stimulating agents (ESAs) have blunted not only the drug's commercial potential but also the prospects of finding a partner to help steer it through Phase II and III clinical trials.
India's Shasun Chemicals and Drugs is setting up a process development plant in Piscataway, New Jersey, its first ever facility in the North American market.
Members of the Synthetic Organic Chemical Manufacturers Association (SOCMA) have slammed competitors from emerging markets, claiming poor quality goods and lack of technological competence in regions such as China, India and Eastern Europe.
Novartis has been given a warning by US regulators detailing significant failures in its investigation into tracking down the source of contamination in some of its vaccines.
Rapid identification of bird flu infection will be the key to controlling a pandemic should the virus learn how to transmit between humans. A new lab-on-a-chip could provide diagnosis in as little as 30 minutes.
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