The Challenge of Change - Managing Excipients Control
Colorcon
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The recovery that has taken packaging and processing machinery company IMA to profitability in 2006 has continued, helped by new opportunities in the biotech sector and a strong growth in generics.
Seattle drug firm ZymoGenetics has taken Bristol-Myers Squibb (BMS) to court for infringement of its fusion protein technology patents by several products, including arthritis medication Orencia (abatacept).
Bruised by Novartis's snub over a $600m (€466m) vaccine plant, Maryland has commissioned a study on what more the state can do to attract a major cell culture vaccine manufacturing facility there.
Germany's Merck has announced its biggest investment in pharmaceuticals in its 338-year-old history, as its top-selling oncology drug Erbitux (cetuximab) has driven the company to allocate €190m for the construction of its first biopharmaceutical production plant at its headquarters in Darmstadt.
US generic drugmaker Mylan has agreed to spend around $736m (€573.4m) to acquire a controlling stake in Matrix, an Indian manufacturer of active pharmaceutical ingredients (APIs) and solid oral dosage forms, as relentless competition continues to fuel consolidation in the generic industry.
Scientists believe they have discovered a novel way in treating people suffering from anthrax poisoning, which could overcome the problem of antibiotic resistance that is becoming increasingly common in southern and Eastern Europe and Africa.
In the first drug master file (DMF) approval of its kind, the US Food and Drug Administration (FDA) has approved the sale of metformin hydrochloride tablets which are produced by an Indian company using a pharmaceutical formulation intermediate (PFI), an alternative to sourcing active pharmaceutical ingredients (APIs) which could revolutionalise the conventional pharmaceutical manufacturing model.
Canadian contract manufacturer Patheon has teamed up with specialty pharmaceutical firm Depomed to offer its clients a controlled release formulation which can grant their drugs increased bioavailability and less frequent dosing.
Industrial enzyme maker Novozymes is seeking to strengthen its presence in the biopharmaceutical market by offering to acquire Australian biotechnology firm Gropep for AUD83.6m (€49.6m), eager to become a supplier of recombinant ingredients for the biopharmaceutical industry.
Biopharmaceutical firm Altus has asked contract manufacturer Althea to produce Phase III quantities of a crystallised formulation of human growth hormone (hGH) which can be administered subcutaneously weekly instead of daily.
Researchers have identified a protein that is thought to defend the intestinal against microbial invaders offering new insights into how the intestine fends off pathogens and potentially leading to new inflammatory bowel disease medications.
Thermo Electron has reported an operating profit growth of 26 per cent to $143.2m (€111.2m) and boosted its profit margin by three percentage points to 20 per cent in its second quarter results.
Fisher Scientific has reported a second-quarter pre-tax profit jump of 31 per cent to $146.1m (€113.4m), reflecting the success of recent acquisitions and operating initiatives.
Difficulties in identifying tablets have emerged as a major issue in a recent US survey of 150 pharmacists who are warning drugmakers that the lack of distinct appearance in pills leads in dispensing errors that cost more than 7,000 lives each year just in US hospitals.
Looking for $45m (€35m) in savings, Teva has decided to abandon its drug manufacturing plant in Cidra, Puerto Rico, as it scrambles to adjust capacity seven months after its acquisition of Ivax.
Strong demand for anti-cancer cytotoxic active pharmaceutical ingredients (APIs) has led Nicholas Piramal (NPIL) Pharma to upgrade infrastructure and hire more staff at its high potency substances (HPS) facility in Grangemouth.
Despite its consolidation, the competitive consumable sector still offers potential for rapid growth and better profits in the biopharmaceutical industry, while contract bioprocessing services will be increasingly in demand, according to a new market report by D&MD Publications titled "The Bioprocessing Industry - Increasing Capacity, Production, and Efficiency."
Rexam, the world's largest beverage can maker, has bought Indian pharmaceutical packaging firm Truepack for £5m (€7.3m), hungry for a slice of the country's growing pharma market.
Researchers have demonstrated the effectiveness of a new drug for treating infections caused by Staphylococcus aureus bacteria representing the first drug of its kind to be FDA approved in two decades.
For the first time Merck has opened the doors of its under-construction manufacturing plant in North Carolina to public officials, boasting it will eventually contribute about two-thirds of its annual live-virus vaccine production.
A survey of eleven production plants of major drugmakers has revealed considerable variation in capacity utilisation, with the top performers being those who embrace automation and spend little on non-core activities.
Instrumentation provider ABgene has launched the first automated device for the opening and closing of screw caps on sample tubes that it claims is three times faster than the manual method.
Buoyed by lucrative biodefense contracts, Emergent BioSolutions has showcased a new large-scale vaccine production facility in Michigan which it will use to make Biothrax, the only vaccine approved in the US for the prevention of anthrax infection.
Generex has registered a new patent in the US that covers broad claims for the delivery of macromolecules via the buccal cavity of the mouth, further safeguarding its RapidMist drug delivery technology which it uses to spray insulin into the mouth.
Optoelectronic specialist Opto Technology has launched a new low profile heater plate to be used for thermal reactions.
As it continues to expand, Decision News Media is currently seeking two new journalists to join its Pharmaceutical & Science News Group in Central London.
Patients suffering from Alzheimer's disease are one step closer to receiving Novartis's Exelon as a transdermal patch instead of a capsule following an international clinical study which showed that the new delivery method reduces side effects without compromising on efficacy.
A cartridge shortage that forced Amylin and Eli Lilly to ask 40,000 physicians in the US to stop prescribing their injectable diabetes drug Byetta to new patients has come to an end thanks to a boost in production by contract manufacturer Baxter.
Newly-approved pearlescent pigments that can produce sparkly metallic, satiny and shimmery finishes on drug coatings could be used as one additional step in the fight against counterfeiting, say its developers, EMD Chemicals - part of part of German drug giant Merck.
Ciphergen Biosystems has agreed to sell its proteomics instrument business to life science research firm Bio-Rad Laboratories for $20m (€15.6m).
Dendreon has finished the construction of its New Jersey manufacturing facility which it will use to produce its investigational active cellular immunotherapy for advanced prostate cancer, hoping to be the first to bring it to patients.
Albany Molecular Research (AMRI) has announced a multi-year drug substance manufacturing agreement with New River Pharmaceuticals, as its attention deficit hyperactivity disorder (ADHD) medicine looks set to hit the market.
Newly-approved pearlescent pigments that can produce sparkly metallic, satiny and shimmery finishes on drug coatings could be used as one additional step in the fight against counterfeiting, say its developers, EMD Chemicals - part of part of German drug giant Merck.
Spurred on by the frustration of drug manufacturers, governors from four US states have petitioned the US Food and Drug Administration (FDA) for clarity in their requirements for the production of generic versions of insulin and human growth hormone (hGH), the first step to opening the market up to generic biopharmaceuticals.
Nexcelom Bioscience, a provider of instruments for cell-based assays, has just launched a new cell counter to make the cell counting process quicker and easier.
US manufacturers must stop shipping prescription drugs in bulk containers, leaving pharmacies to repackage them, as this practice makes the supply chain more vulnerable and leads to medication errors, the Healthcare Compliance Packaging Council (HCPC) has warned.
Pennsylvania environmental regulators have accused Merck of hampering their investigation of a chemical discharge from its West Point facility that resulted in a major fish kill on the local creek and threatened the water supplies for the city of Philadelphia.
The convenience of non-invasive insulin delivery methods is set to overcome their high cost and concerns about safety and efficacy, with the greatest beneficiary being the European inhaled insulin market which is predicted to swell from $49.3m (€38.5m) in 2006 to $611.7m in 2012, according to two new market reports from Frost & Sullivan.
Biogen has revealed details of a potential new pathway in rheumatoid arthritis (RA) that could provide unique insights into the disease process and eventually a new approach to developing RA therapies.
Agricultural firm Embrex has installed its in ovo delivery system and egg remover at the production facility of Shenzhen Neptunus Interlong, believed to be the largest and most advanced human influenza vaccine manufacturing plant in China.
Researchers have developed a new light microscope that is so powerful ituses a nanometre-scale resolution to spot individual proteins in a cell byusing a fluorescent labelling method.
India's potential to further boost its already dominant role in global generics production, as well as an offshore location of choice for contract manufacturing, presents an opportunity worth an estimated $48bn (€38bn) in 2007, though regulatory reforms and improved intellectual property rights are needed if its domestic market is to be tapped, a new report from KPMG suggests.
More problems at Patheon's Puerto Rican production facilities in the third quarter of 2006 are expected to reduce the contract manufacturer's earnings before interest, tax, depreciation and amortisation (EBITDA) by more than $9m (€7m) compared to last year, forcing it to negotiate its credit agreement with its lenders.
The US Food and Drug Administration (FDA) has censured three American national pharmacies for using the traditional practice of compounding as a ruse in order to operate as drug manufacturers, producing thousands of unapproved copies of commercially available nebuliser medications that do not meet good manufacturing practice (GMP) standards.
US biotech firm Genzyme has been given a green light by the US Food and Drug Administration (FDA) to begin manufacturing its kidney drug at its Waterford facility in Ireland.
IBM has unveiled a radio frequency identification (RFID) system for the tracking and tracing of pharmaceuticals, confident it will accelerate the adoption of the technology by the drug industry.
Researchers have theorised that a peptide found in primates could halt the HIV-1 virus from infecting blood cells. The discovery could form the crux of an effective drug therapy, which may overcome resistance exhibited by current treatment use.
Gentronix has been granted a research award, which is to fund a potentially viable alternative to animal testing, reducing the need for their use during drug development.
While Lonza's biopharmaceutical business has taken off, tough competition from cheap Asian competitors is eating away at its exclusive synthesis business - meanwhile, the whole business is being hit by rising raw material and energy costs.
An Infra-Red analyser has been named one of the Top 100 most technologically significant products introduced into the marketplace over the past year.
Drug manufacturers are increasingly turning to specialised providers of analytical services for the solid state characterisation of their formulations, seeking answers to processing issues, drug delivery challenges and even protecting drug patents.
When selecting a pharmaceutical formulation, the conventional wisdom has been to manipulate a drug delivery platform to make it compatible with a drug's properties, yet the opposite approach may have several benefits if enough thought is put into it early in the development process, according to Brookwood's chief scientific officer.
Researchers have found that a simple and inexpensive test can help determine which patients with venous thromboembolism (VTE) are at low risk for recurrence and can therefore avoid unnecessary and potentially dangerous long-term anticoagulant treatment.
Australian-owned Campbell Brothers has entered the Scandinavian laboratory market by acquiring Swedish-based lab group Analytica.
The excipients used in a protein formulation and the method of production can impact not just the physical and chemical stability of biologics but also their in vitro and in vivo performance, cautions Durect's executive director of biopharmaceutical R&D.
The global demand for virgin activated carbon is tipped to rise five per cent per year to reach 1.2m metric tons by 2010, fuelled by increased use in the pharmaceutical sector.
In their hunt for DNA that is amplified in cancers, researchers have discovered a new cancer-promoting role for a gene that has been shown to transform mammary epithelial cells into cancerous ones.
Pharmaceutical manufacturers will be among a number of exporters and importers operating within the EU that face paying tens of millions of euros to comply with a new regulation aimed at reducing terrorism, fraud and counterfeit products.
West Pharmaceutical Services has reported a huge surge in both sales and profits for its second quarter, spurred on by the increasing demand for injectable drugs as well as the lucrative Exubera manufacturing contract, which helped double sales for the segment, although failed to stop a fall in profit margin.
Researchers have created a compact optical device that could make"lab-on-a-chip" possible by shrinking all the sensing power of biosensorsand developing a new design for photonic crystals in the process.
Niro Pharma Systems has launched a new spray-drying nozzle to produce commercial quantities of fine powder drugs for inhalation.
Pharmaceutical excipients can have a profound impact on the release profile of drugs, driving fine chemical companies to raise their game since they realise their clients see excipients as more than inactive ingredients.
Merck Sharp & Dohme (MSD) has invested $100m to expand its manufacturing plant in Singapore, bringing the drug giant's investment in this budding region to over S$1bn (€0.5bn).
Steritool has launched the world's first crowbar made entirely of stainless steel - designed to serve in zero-particulate environments and eliminate contamination.
Failure to get it right in designing and implementing a manufacturing process results in the loss of time and money, but the risk of this can be minimised if some basic organisational steps are followed, argues Brookwood's director of manufacturing.
Nanogen and Fisher Scientific have announced an expansion to their relationship to include a research and development collaboration in molecular diagnostics. The collaboration agreement complements Fisher's equity investment in Nanogen announced in March 2006.
More and more drugmakers are turning to health care companies not just for their drug delivery technologies but also for their regulatory and manufacturing expertise, asking them to take their product from early stages all the way to post-approval.
Researchers have developed a new method by which cells can be glued to an exact position on a carrier.
Cambrex's Q2 results show that the life sciences firm is slowly making a comeback after being crushed by a $140.3m (€116.7m) loss in Q4, however, it has failed to completely stem the bleed from its Biopharma unit, blamed for much of the company's woes.
Canada's National Centre for Foreign Animal Disease (NCFAD) has been designated as a reference lab for Bovine Spongiform Encephalopathy (BSE) by the World Organisation for Animal Health known as the OIE.
Are big pharma companies uninterested in supporting novel formulations, preferring to stick to low-risk drug delivery systems, or are they resourceful innovators that bring new technologies to the market? Two pharma grandees holding opposite views battled it out at the Controlled Release Society's annual meeting in Vienna.
CHDI and Edison Pharmaceuticals have entered into alliance that looks to develop effective therapeutics in targeting Huntingdon's disease - a disorder that currently has no way to stop or reverse the its progression.
The Food and Drug Administration (FDA) will beef up its process for disclosing the conflicts of interest of its advisory experts in a bid to restore its reputation after a survey suggests its scientists may be too closely tied with the drug industry and scientific evidence is being "suppressed and manipulated."
Nektar Therapeutics has closed its processing plant in Bradford, UK as it shifts its focus to developing its own drug products using its own drug delivery technology.
Even with the most advanced analytical equipment, elucidating the complete conformational characteristics of proteins still represents mission impossible, often making their formulation problematic, yet there are always ways to improve their pharmacokinetic properties, according to Octoplus's chief scientific officer.
Chinese company Dragon International has fought its way into its first packaging materials distribution deal in the burgeoning Indian pharmaceutical market.
The Food and Drug Administration (FDA) has been left red-faced after a survey recently released by the Union of Concerned Scientists (UCS), found a "disturbing level of interference in the agency's research".
PerkinElmer has announced the acquisition of Macri Technologies and NTL Laboratories in a deal that means the Health Sciences and Photonics company take charge of a novel screening test for first-trimester prenatal risk assessment.
Most pharmaceutical companies know little about how to make biopharmaceuticals on a large scale and so they need to develop in-house expertise as well as outsource several steps in their production chain, advises the head of chemistry and production at Genzyme Pharmaceuticals.
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