The Challenge of Change - Managing Excipients Control
Colorcon
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Researchers have taken a special interest in mechanisms they have identified as an explanation for the causes of Parkinson's disease, which they say, may facilitate research aimed at finding novel medical treatments and other therapies.
The insulin market is set to explode over the next five years as uptake of insulin therapy is likely to increase with sufferers benefiting from heightened awareness and knowledge as well as the influx of affordable, innovative product solutions.
Partnerships in drug delivery need to fairly reflect the risk all parties take but there must also be a champion to drive the project forward, according to Pfizer's director of drug delivery.
GlaxoSmithKline (GSK) said it has developed a vaccine against the H5N1 bird flu strain that can trigger an immune response at a much lower dose than other vaccines in development.
Purdue Pharma is the first drug manufacturer to implement a new software program that allows firms to order all Schedule I & II controlled substance purchases on a single electronic form - potentially saving up to 90 per cent on ordering costs.
The US Food and Drug Administration (FDA) has announced a series of new policy and regulatory developments to modernise the way it monitors clinical trials and bioresearch.
US researchers have created a nanoscale probe that can capture the topography of biological objects in their normal environment, which paves the way for the discovery of new biomarkers leading to better drug design on the cellular level.
Aegis Therapeutics has unveiled a new formulation technology employing non-toxic excipients that maintain the physical stability and physiological activity of protein and peptide therapeutics while reducing immunogenicity.
Mass spectroscopy as an analytical laboratory technique proved it's worth again recently after Cerno Bioscience and Wyeth Pharmaceuticals jointly produced a paper that demonstrates the high mass accuracy that can be achieved using triple quadrupole mass spectrometers.
In a controversial move, the US Food and Drug Administration (FDA) has given the final nod of approval to pharma companies who want to add colourful pearlescent pigments to their drugs to give them that "special something."
Anderson Packaging has bought 12 acres of land next to its existing US headquarters and now plans to build another new facility to expand its contract pharma packaging capacity by 20 per cent.
BASF has unveiled new pharmaceutical auxiliaries which release active ingredients more quickly, particularly when it comes to small tablets.
UK and Chinese R&D firms are this week being urged to band together to develop alternatives to the practice of using endangered animal parts to feed the vast traditional Chinese medicine industry.
Omnia Biologics has sealed a deal to help the Aeras Global TB Vaccine Foundation in its quest to make quantities of a new TB Vaccine that will "fulfil all the needs of the developing world."
Chugai Pharmaceutical has decided to manufacture a modified version of Roche's Tamiflu (oseltamivir) in a dry syrup formulation which can be stored at room temperature after the bottle is opened, allowing for more storage capacity as fears of a possible bird flu pandemic spread.
A new white paper has been made available to laboratories worldwide, which aims to minimise the risk of infection through focused biosafety reviews and further reinforce the required level of infection control.
A new specialty chemicals company, Vertellus Specialties, has been created in the US to make high-growth and high-value pharmaceuticals.
Israeli biopharma firm Kamada will manufacture transferrin for an undisclosed European pharma firm embarking on the first ever clinical trials of a drug that includes the substance.
Rentschler Biotechnologie has heralded the start of a €50m expansion to increase its capacity to produce antibodies and mammalian cell culture-derived proteins on a commercial scale.
Pfizer has issued another recall for packs of its blockbuster cholesterol drug Lipitor after UK regulators found evidence of more counterfeit product in the legitimate supply chain from a batch whose withdrawal was supposed to have been completed a year ago.
The discovery of a genetic code for DNA organisation within a cell's nucleus has significant implications in future drug discovery processes as cracking the genetic code that determines nucleosome location on the DNA strand will aid identification of drug targets.
Dor BioPharma has reached the first stage in manufacturing what could be the world's first vaccine for the deadly ricin toxin.
Irish pharmaceutical specialist Guy & Co has been strengthened by the recent acquisition of leading US-based pharmaceutical packaging specialist Pharmagraphics according to its parent company and will now be known as Pharmagraphics Guy.
Specialty chemicals firm Cognis has received good manufacturing practice (GMP) certification for its production of pharmaceutical excipients in Germany, the first chemical company in the world to do so but certainly not the last.
As it consolidates its manufacturing operations in the US, Watson Pharmaceuticals has received a warning letter from the US Food and Drug Administration (FDA) accusing it of using the wrong ingredients in the production of capsules, failing to prevent contamination and botching testing procedures.
After a ruthless battle between US states, Novartis has selected Holly Springs in North Carolina for its vaccine manufacturing plant which will use novel cell culture technology to dramatically speed up production - the first facility in the US to do so.
Momentum is growing at the UK's new National Biomanufacturing Centre (NBC) as its operator Eden Biodesign inked a second contract at the centre - set up to establish England's Northwest as one of the top biomanufacturing hubs in Europe.
European researchers have not only devised a new diagnostic lab tool for prostate cancer but have also identified a new molecular marker that makes the identification of the disease much quicker.
A new non-invasive optical method of monitoring oxygen concentration and pH levels in disposable bioreactors is now available from UK firm Cellexus Biosystems.
With its manufacturing practices in Puerto Rico censured and marketing approval of its new oral contraceptive delayed because of its packaging, Wyeth has announced a plan to address its manufacturing issues but cautions there is no quick fix to its woes.
Labelling and packaging equipment company Advanced Dynamics has unveiled a new machine to label the outer packaging of pharmaceutical products in Braille, allowing companies to comply with EU regulations.
Indian custom chemical synthesis firm Denisco has opened up shop in the US to capitalise on the growing demand in North America for high-quality, low-cost complex organic molecules.
The US Food and Drug Administration (FDA) has turned down Nastech's generic version of the nasal spray Miacalcin for the treatment of osteoporosis because of the possibility of an interaction with a preservative used in the formulation, sparking heated debate in the US about whether calcitonin should be treated as a generic or a biosimilar drug.
Bio-Rad Labs and Integrated DNA Technologies (IDT), have announced a collaboration to develop RNA interference (RNAi) tools sets for life science researchers.
In an incident Roxane Laboratories warns could have life-threatening consequences, a manufacturing lot of azathioprine tablets has been recalled in the US and Puerto Rico following the discovery of methotrexate tablets in one of its bottles.
Biotechnology firm Alexion has acquired a Dow biomanufacturing facility in Rhode Island as it gears up for the commercialisation of its blood disorder drug Soliris, yet the move does not signal the end of the company's contract manufacturing relationship with Lonza.
Newly formed UK biopharma firm Synexin has bagged a £1.2m (€0.9m) bioprocessing grant as part of a nationwide push to excel in the emerging field of biopharmaceuticals.
Sales, sales, sales has been the focus of drug manufacturers so far this year, while interest continues to remain high on the topics of India and generics.
Looking to expand its laboratory testing and consulting services, PharmEng has acquired Rootlink Tecknic, a laboratory instrumentation automated solution sales and service company based in Toronto.
AstraZeneca will be using Werum's PAS-X system at its two German production sites to collect operating data from its packaging lines and define and evaluate key performance indicators (KPI), improving equipment performance.
Archemix has announced the formation of a strategic alliance with Elan to discover and develop first-in-class aptamer therapeutics to treat autoimmune disease.
Biopharmaceutical firm Nektar has agreed to fork out $25m (€20m) to settle a patent lawsuit by the University of Alabama in Huntsville (UAH) concerning the company's PEGylation delivery technology currently used in eight approved biologic drugs in the US and Europe.
US scientists have discovered that sugar and olive oil do not just belong in the kitchen - but could potentially be used to develop naturally-derived nanomaterials for drug delivery systems and biological scaffolds.
Although India's star continues to rise, it pales in comparison to China as a destination of choice for low-cost drug manufacturing - for now.
GlaxoSmithKline (GSK) has asked vaccine developing firm Antigenics to supply it with more of its QS-21 adjuvant as its vaccines progress in the pipeline, while at the same the British drug giant is pushing ahead with its own adjuvant, MPL, seeking not just clinical but also manufacturing benefits.
Malvern Instruments has acquired Spectral Dimensions, a provider of near infrared (NIR) chemical imaging instrumentation and software, seeking products that can enhance pharmaceutical formulation and manufacturing processes.
Active pharmaceutical ingredient (API) manufacturers in Europe are struggling to differentiate their capabilities and compete in an outsourcing market suffering from overcapacity, diminishing profitability and threats from Asia.
Analytical X-ray specialists, PANalytical has launched its solution to enables X-ray fluorescence (XRF) analysis of fuel, oil and oil derivatives. The package attempts to overcome the traditional challenges associated with XRF analysis of oils while keeping costs low.
Northfield Laboratories, a company specialising in the development of human hemoglobin-based oxygen carriers, has splashed out $6.7m (€5.2m) to buy a plant it previously leased in Illinois, as it edges closer to commercialising its only product.
In a landmark decision that will speed up the manufacturing of influenza vaccines, the US Food and Drug Administration (FDA) has approved the use of reverse genetics technology in the production of MedImmune's seasonal intranasal vaccine Flumist and its refrigerator-safe version, CAIV-T, allowing them to be the first on the market using this technique.
French-owned software firms Axway and Cyclone Commerce have joined forces with US drug distribution firm McKesson to develop new and cost-effective IT to support the pharma industry in its venture to introduce item-level tracking to fight fake drugs.
Isopak is flaunting a new automatic check weigher for capsules and tablets, promising more accuracy than ever before.
Maryland is no longer in the running for a $500m (€392m) vaccine manufacturing plant Novartis is seeking to build in the US, as speculation about which state will host America's first cell culture-derived influenza vaccine plant is reaching fever pitch.
Discovery Laboratories is claiming progress in its struggle to correct manufacturing problems related to Surfaxin, its experimental respiratory treatment for infants, yet the goal of overcoming the process validation issues that prevent it from having the drug approved in the US seems as distant as ever.
Cardinal Health is the latest firm to benefit from Roche's global recruitment drive for manufacturers to help boost its supplies of the bird flu drug coveted by governments across the world - Tamiflu.
Takeda Pharmaceutical has jumped at the chance to use a new technology that its developer, Spherics, claims can improve the efficacy of a drug while reducing side effects, providing more consistent drug levels and enhancing compliance.
The Videojet 1310 ink jet printer from Videojet Technologies is now available in North America with a simpler user interface, similar to its popular Videojet Excel ink jet printer.
Despite the uncertainty about its direction, German pharmaceutical company Altana has opened a new tablet production facility in Cork as it tries to cope with demand for Pantoprazole, its blockbuster stomach ulcer drug.
A recent paper has emerged, which details results of a clinical laboratory test and its ability to accurately predict drug response in lung cancer. The test gives way to the possibility of less invasive testing.
The Immune Response Corporation (IRC) claims it has developed a cell culture medium that can double viral antigen yields in HIV vaccine development.
Abbott's Kaletra, the biggest-selling drug of a class of HIV medications known as protease inhibitors, has won the thumbs up from the European Commission with a melt extrusion formulation which enhances solubility, requires fewer processing steps, and, crucially, does not need to be refrigerated.
UK firm PowderMed has contracted US firm Althea Technologies to manufacture clinical supplies of its flu vaccine that can significantly speed up production.
An enzyme-based process operated by Lonza for the production of the major chiral building block for Pfizer's Lipitor, the world's best selling drug, has won its designer Codexis a top green chemistry award for its high yield, speed, efficiency and reduction of waste and purification equipment.
Although patent expirations are set to increase the size of the generic drug market, the impact of greater scrutiny from healthcare policymakers means that generic manufacturers may make more drugs but not necessarily more money.
In the face of generic competition, Abbott has asked Irish biotechnology firm Elan to use its NanoCrystal technology to develop an "all in one" oral dose formulation combining two cholesterol drugs, AstraZeneca's Crestor and Abbott's Tricor, as demand for combination therapy, now 15 per cent of the cholesterol market, continues to grow.
SR Pharma has recruited Genzyme, BioSpring and OctoPlus to formulate and manufacture its lead RNAi therapeutic product Atu027 to good manufacturing practice (GMP) standards, as its liposomal drug delivry system moves forward.
Technology firm Symyx has acquired Autodose, a maker of precision powder-dispensing equipment, as it seeks to develop the next generation of high-throughput benchtop automation systems.
Inspection and certification group SGS has officially launched a laboratory in Shanghai dedicated to quality control testing of pharmaceuticals, biopharmaceuticals and medical devices, as China's appetite for contract analytical services increases.
UK biopharma firm Adjuvantix has developed a new technology that it claims can increase the effectiveness of vaccines as well as drugs for cancer, inflammatory diseases and infectious diseases such as tuberculosis and AIDS.
Genevac have developed a Fast Lyophilisation Process that aims to provide the ultimate solution to the problems encountered by lab technicians when handling HPLC solvents.
Tate and Lyle has announced the launch of Meritab - a new direct compressible dextrose - that allows pharma tablet manufacturers to stop using wet granulation processes, and so offers a cost effective and simplified production process.
In an incident that state and federal environmental regulators are treating as "serious," Merck released 25 gallons of a cyanide-containing chemical from its West Point facility in Pennsylvania to the sewer, killing hundreds of fish and triggering health advisories.
GS1, the global not-profit organisation, that designs and implements barcode standards, has announced a global adoption date of 1 January 2010 for a new bar code with Reduced Space Symbology (RSS), which can store more data in half the amount of space and offers a temporary alternative to radiofrequency identification (RFID) technology.
Cambrex Bio Science has successfully completed its first monoclonal antibody project in the company's new cell culture bioreactor, as well as its first small-large molecule conjugation project.
The sale of Clariant's Pharmaceutical Fine Chemicals (PFC) to equity firm Towerbrook for around SFr110m (€70m) has been completed and the unit, now called Archimica, is determined to dominate the pharma raw materials market.
As America desperately waited for its influenza vaccines, Chiron had to deal with major quality control issues between July and October 2005 at its troubled vaccine manufacturing plant in Liverpool according to a US Food and Drug Administration (FDA) inspection report.
Copapharm Europe, the alliance of specialist packaging companies, has announced "healthy" sales figures for 2005, as its one-stop pan-European approach to the supply of pharmaceutical packaging equipment is becoming more popular.
A dry powder nasal flu vacccine is being hailed by its developers at DelSite Biotechnologies as a unique storage solution, providing delivery advantages over traditional flu vaccines in the event of a bird flu pandemic.
New Brunswick Scientific (NBS) has introduced two new benchtop incubator shakers, the first in a range of eight new models replacing the original C-Line. The shakers have been designed to allow reproducible results all the way down the cell line.
A new generation of drugs that target specific areas of the body has created new challenges for dissolution testing, as many recent active pharmaceutical ingredients (APIs) are poorly soluble in traditional media and need novel testing procedures.
Sanofi pasteur's vaccine manufacturing plant in Pennsylvania, where half of America's influenza vaccines are made, has been served with a warning letter by the US Food and Drug Administration (FDA), asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.
New guidelines for the import and manufacture of medical devices in India have now come into effect, aimed at increasing world confidence in medical devices made in the region.
Best Practices Research and Consulting have put together a toolkit to help pharma companies improve manufacturing quality assurance and efficiency.
Frost & Sullivan has awarded biopharmaceutical firm Cytogenix with its 2006 award for innovation in biotechnology processing for its cell-free manufacturing method that enables generation of large quantities of high-purity DNA in small highly automated production modules at a fraction of the time and cost of traditional bioprocess methods.
Shield Medicare, a British supplier of alcohols, disinfectants and consumables to pharmaceutical cleanrooms, has been taken over by US cleaning products provider Ecolab, seeking to capture more of the European market.
A report on the US Food and Drug Administration's (FDA) enforcement record by US Democratic lawmakers has highlighted a plunge in the number of warning letters the agency has sent to drug manufacturers since 2000, citing several examples where violations spotted in site inspections were not followed through.
Specialty chemicals firm Degussa has launched a new hydrophobic silica excipient which is particularly suitable for very hygroscopic and cohesive powders as it can significantly improve powder flow.
BioPartners has failed to bring its second biosimilar product into Europe after the European Agency for the Evaluation of Medicinal Products (EMEA) issued a negative opinion on its hepatitis C drug, citing characterisation, manufacturing and quality control concerns.
Intec Pharma has enlisted two North American dosage form manufacturers to make "supergenerics" using its new method of oral drug delivery that can transform existing drugs into more powerful therapies.
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