The Challenge of Change - Managing Excipients Control
Colorcon
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Spending up to $400m (€330m), Indian drugmaker Ranbaxy has ended the week with three acquisitions of European generic companies under its belt, hoping a strong foothold in Europe will help it offset its declining fortunes in the US.
Illumina has introduced two new genotyping BeadChips that offers the highest data quality of any genotyping array currently available, with call rates that routinely exceed 99 per cent, reproducibility and accuracy approaching 100 per cent.
Level and flow measurement product providers, Krohne, were out in force at Interphex 2006, showcasing a raft of products for the manufacturing industry. Its presence within the pharma and chemical industry has been boosted recently with the global supply contract agreement with Degussa.
Modular optimal subsystems developer Polychromix has released what it claims is the first data analysing all-in-one spectroscopic unit, allowing anyone to perform chemical analysis in the field at an unprecedented low cost.
Contract manufacturer of sterile injectable products HollisterStier has outlined plans to double its production capacity and laboratory facilities, as it responds to increasing demand.
Nilfisk used Interphex, New York, to showcase its new vacuum designed to collect sub-micron particles and bring the cleanliness and hygiene standards required in cleanrooms into a compact machine.
Scientists have discovered the existence of a HIV accessory protein that disables host immunity via receptor-protein intermediary in a discovery that points to possible novel ways to fight AIDS, immune disorders and sepsis.
New legislation on the good manufacturing practice (GMP) of pharmaceutical excipients in Europe, which could complicate the quality control of imports of excipients to the EU and make it unattractive for some vendors to remain in the market, is in the works at the European Commission (EC). In-PharmaTechnologist.com spoke to Sabine Atzor, who is charged with coordinating the drafting of the directive at the EC, about what it is likely to look like.
Elsevier have launched a drug tracking and analysis tool that is set to greatly benefit laboratory researchers working in the pharmaceutical and biotech professionals by bringing together drug characteristics and status within a database.
Dutch biotechnology firm Crucell has announced it will sell vaccine manufacturer Rhein Biotech to US company Dynavax for around $12m (€10m) as it chooses to focus on specialised vaccines such as those for Ebola and malaria.
Inspection technology specialist PTI has launched a new non-invasive inspection system at INTERPHEX for multi-cavity blister packaging made with any material, flat or glossy finish, printed or nonprinted surface, allowing fast changeover from one blister format to another.
The Optima Group's presence at this year's Interphex show in New York was significant as it gave In-PharmaTechnologist.com the first look at the Group's recently implemented shift in focus, resulting in a product range expansion and a raft of acquisitions to complement its major areas of operation.
Eriez used the recent Interphex show to launch its new magnetically-driven vibratory feeder for large quantities of bulk drug materials, designed to save manufacturers both time and money.
Researchers have discovered a series of enzyme inhibitors that appear to block the replication of the SARS virus - a finding that could help speed up the research and development of drugs used to treat the killer virus.
Rapid growth in the biopharmaceutical sector in China, India and Southeast Asia has prompted US filtration specialist Pall to devote more resources and industry experts to these regions, as the 14 per cent growth seen in its BioPharm business over the last year is largely attributed to the well-established presence the company has there.
Millipore took the opportunity to announce the availability of the new Milli-Q Advantage system, which has been designed to meet the ultrapure water quality needs of the pharmaceutical, biotechnology and clinical sectors.
Systech and Domino Printing Sciences has announced an agreement that will combine Systech's TIPS Serialised Product Tracking methods with Domino's marking and coding technology as a solution to combat counterfeit product and increase patient safety.
Looking to establish itself in Eastern Europe, French drug maker Sanofi-Aventis has bought a 24.9 per cent stake in Czech generic drug firm Zentiva for $514.7m (€430m).
A simple laboratory method to treat Parkinson's disease, which involves electric currents, has been developed by researchers, who believe the use of this method will reduce or eliminate the need to treat this disorder with drug therapies.
Ranbaxy has announced the purchase of Senetek's Autoinjector rights and assets for its proprietary disposable autoinjector for self-administration of parenteral drugs, adding to Ranbaxy's growing presence in the growing self-medication market.
Despite hurdles such as manufacturing overcapacity, limited drug approvals and intense competition from Asian companies, a new report from market research analysts Frost & Sullivan predicts revenues in the North American fine chemicals sector will grow from $21.29bn (€17.78bn) in 2005 to reach $28.62bn in 2011, driven by the production restructuring announced by pharmaceutical majors.
Organon, Akzo Nobel's healthcare division, has conceded it will have to close its Diosynth manufacturing plant in Scotland by the end of the year since it cannot divest it, as the unit's lack of competitiveness in the production of fine chemicals and pharmaceutical starting materials appears insurmountable.
LGC Promochem has launched its 2006 edition of its free pharmaceutical reference substances and impurities catalogue, providing researchers and analysts in the pharmaceutical R&D and manufacturing generic industry with a central source to access every relevant reference and impurity standard available, along with a range of associated analytical laboratory products.
The new Automated Emitted Dose (AED) system from Astech allows for in-line emitted dose testing of inhalers, saving time and money by generating results from the production line which determine whether full batch production should continue.
Responding to surging demand for its flu drug Tamiflu, Roche has announced it is expanding its external contractors to fifteen in nine different countries, as its needs for intermediates and finished product increase.
A new discovery paves the way for new laboratory cancer research after scientists have been able to explain just how a gene variant carried in 15 per cent of the population may increase the risk of developing cancer.
Analytical instrumentation supplier Malvern has introduced a new inhalation cell for its Spraytec system for particle size analysis of aerosols and sprays, allowing the rapid characterisation of systems such as dry powder inhalers (DPIs), metered dose inhalers (MDIs) and nebulisers.
Unlike with active pharmaceutical ingredients (APIs), there are no clear governmental good manufacturing practice (GMP) guidelines for excipients in the US, Europe or China. Now the International Pharmaceutical Excipients Council (IPEC) is launching a new guide for the GMP manufacturing of excipients and is warning the industry: agree on what the exact standards should be or the regulators will do it for you.
British gene therapy firm Oxford Biomedica has licensed its VSV-G viral envelope technology for gene delivery to American biotech company VIRxSYS which hopes it can use it to successfully produce its promising anti-HIV/AIDS product currently in Phase II trials.
The European Association of Pharmaceutical Full-line Wholesalers (GIRP) has outlined measures it is taking to keep counterfeit medicines out of the legitimate supply chain while urging pharmaceutical manufacturers and pharmacists to do more together to address the issue.
The US Congress has asked the country's National Institute of Environmental Health Sciences (NIEHS) to conduct research on the connection between vaccines containing mercury and neurological disorders, further battering public confidence not just in the US Centers for Disease Control and Prevention (CDC), but in vaccine manufacturers as well.
Sigpack Systems have announced a range of pharmaceutical applications that include integrated solutions for secondary blister packaging and a system for packaging pharmaceutical powders that make their debut at Achema 2006.
Millipore are to showcase a range of filtration, chromatography, process monitoring and water purification solutions that are a part of Millipore's response to an increase in lab investments from pharma companies, and the emergence of new biotechnology companies.
As a fever of consolidation continues to sweep the generics market, Iceland's Actavis Group has offered to buy out Croatian rival Pliva in a proposal which values it at $1.6bn (€1.31bn) and aims to create the world's third largest generic pharmaceuticals company.
A consortium of British private companies and a university facility has been awarded $2.6m (€2.13m) by the UK's Department of Trade and Industry (DTI) to produce a slow release vaccine which will eliminate the need for booster doses, improving compliance and slashing the cost of vaccination.
Analytical technology specialists Waters Corporation and Bruker BioSciences have entered into a collaboration agreement to provide greater integration and connectivity between their products, looking to increase efficiency in pharmaceutical manufacturing.
Analytical instrument maker Thermo is promising to make separation more efficient with its new Sorvall RC-6 Plus centrifuge, which offers 4-L capacity and operating at speeds of up to 22,000 rpm, enabling extremely fast processing of samples and making it a high productivity solution in the lab.
Chemical companies Solvay and Akzo Nobel have coughed up $72.8m (€59.7m) to settle a lawsuit from the US Justice Department while having to plead guilty of fixing prices for sodium perborate, an oxidising agent used mainly in detergents, and hydrogen peroxide, which is widely used in the chemical and pharmaceutical industries as a reagent for chemical syntheses.
At the Achema exhibition in Frankfurt this May, UK powder instrumentation company Freeman Technology will unveil software upgrades for its FT4 Powder Rheometer that allow 'real time' bulk density measurement, improving QC even more by detecting subtle changes in bulk density that occur during repeat testing.
Canadian drug outsourcing company Patheon has reported its first quarterly loss since its inception in 1974, swinging from a net profit of $6m (€4.9m) in Q1 of 2005 to a net loss of $11.5m in Q1 of 2006, as problems with production at its Puerto Rican facility, a disappointing product launch at its Whitby site and a weaker than expected demand for its contract manufacturing services have dented the firm's performance.
Robin Engineering Services has made its first foray into selling machinery exclusively for the pharma industry in a deal with Indian manufacturer Chamunda. The partnership will slash the cost of tableting machinery and fluidised bed driers and processors in the UK.
Princeton Instruments/Acton has unveiled its new sensor technology that it claims will revolutionise the world of spectroscopy and triple the speed of current devices.
Researchers in the UK think that knowledge of 'movement routes' is the key to predicting patterns of spread of infectious diseases in humans, which would enable scientists to administer effective drug therapies that are able to halt the disease in the early stages.
Bayer Healthcare has selected Genedata's Bioinformatic platform for its target research and biomarker activities in which the deal will involve the mechanistic analysis of cardiovascular and cancer biomarker genes.
Filtration systems specialist Pall's net profit barely moved in Q2 compared to the similar period last year, up only $400,000 (€331,328) to $32.4m, still its Biopharmaceuticals business, driven by a steady demand in consumables, posted a 4 per cent rise in sales to $80.5m.
Looking for an advantage in the high-value generics market and a boost to its contract development services for research-driven pharmaceutical companies, Swiss chemicals and pharmaceuticals group Schweizerhall has bought German drug delivery firm Novosis in a deal worth up to €82.6m.
In its first venture outside the subcontinent, though certainly not the last of its kind for India pharma companies, contract pharmaceuticals manufacturer Kemwell has bought for an undisclosed sum Pfizer's production plant in Uppsala, looking to expand its services in Europe.
A new laboratory method, which looks for a spinal fluid protein, may identify people with the earliest stages of multiple sclerosis (MS), greatly increasing the effectiveness of drug therapies to treat the 10,000 Americans, who are diagnosed with MS each year.
In what is shaping up to be a new promising area in the verification of drugs, Analytical Spectral Devices (ASD) has received another patent for its RxSpec technology which uses near infrared spectroscopy (IR), as rival company CDEX is also targeting the market.
A $30.1m drop in licence and research revenue and the expensive removal by rebel shareholders of its former CEO Gerard Soula last June have taken drug delivery company Flamel from a net profit of $12.5m (€10.3m) in 2004 to a net loss of $27.4m in 2005, as it tries to find new partners for its polymer-based drug delivery technologies.
Anticipating a US Food and Drug Administration (FDA) approval this year, Dendreon has awarded Diosynth Biotechnology with a long-term contract to supply the recombinant protein antigen component of its novel vaccine for prostate cancer - the third most common cancer in the world.
Despite a 3 per cent drop in sales to SFr8.181bn (€5.212bn), specialty chemicals maker Clariant has posted a 29 per cent rise in net profit for 2005 to SFr192m, thanks to lower interest charges, currency gains and lower taxes, but its Life Science Chemicals division, where intermediates and active pharmaceutical ingredients (APIs) are made for the pharmaceutical industry, is the only one within the company not showing growth.
Analytical technology company Ometric has demonstrated real-time, in-line compliance testing of powders and instantaneous monitoring of blending of pharmaceuticals with its SpectrInline Processware system at the Pittcon exposition currently taking place in Orlando, showing it can minimise recalls, reduce waste caused by time lag, and save resources involved in current sample testing.
Glemser Technologies has released a new version of its labelling software, designed to reduce the costs, complexity and regulatory risk involved with producing pharma product inserts.
The US Food and Drug Administration (FDA) has linked its Counterfeit Alert Network (CAN) to SafeMeds Alert System, an electronic mailing list backed by pharmaceutical manufacturers that sends warnings about fake drugs to anyone who signs up, significantly increasing public awareness and cracking down on fraud.
Swiss QC specialist SGS has opened a laboratory in Singapore for the contract testing of pharmaceuticals, biopharmaceuticals and medical devices, eying a budding market which seems hungry for outsourcing.
Tevopharm, a Bosch Packaging Technology Company, introduces a new control platform for its Pack-2000 (BM) flow-wrapping machine. The controller is designed to enable users to comply with GAMP and 21 CFR Part 11 regulations when feeding or wrapping products such as syringes, vials, blisters and inhalers.
The first clinical laboratory based test for saliva-based oral cancer detection has been developed by scientists, who believe that the clinical value this test demonstrates, could reduce the 350,000 - 400,000 new cases recorded each year worldwide.
Reforms do not come cheap, certainly not for Croatian pharmaceutical company Pliva, whose strategy of abandoning its proprietary drugs in favour of generics may pay off in the long term, but, along with manufacturing consolidation and the patent expiry in the US of its blockbuster antibiotic azithromycin, has taken the firm from $20.2m (€16.9m) net profit in Q4 of 2004 to $41m loss in Q4 of 2005.
The ReNeuron Group has announced it has completed the scale-up and cell banking of its lead stem cell product for stroke, which gives the Company the potential to progress this therapy without the need to re-derive the cells from source material in the future.
TimeMed Labeling Systems has acquired Automatic Business Products (ABP), a provider of business forms and labeling solutions, expanding both its product portfolio and its customer base.
Researchers in the US think they have identified a compound that interferes with the pathogenic effects of Huntington's disease that could lead to the development of a new treatment for the disease as well as making an impact on similar disorders such as Parkinson's disease.
Its upcoming inhalable insulin drug may prove a blockbuster but Nektar's 2005 results brought the biopharmaceutical company further in the red, with a net loss of $108.2m (€91m) in Q4 more than five times higher than the $19.3m loss it posted in Q4 of 2004, as it struggles not just with one-time charges but also with higher expenditure.
Swiss custom manufacturing firm Lonza has entered into a joint venture with investment management company Bio*One Capital to built a $250m (€210m) large-scale mammalian cell culture plant in Singapore, underlying Lonza's confidence that demand for the contract manufacturing of commercial biopharmaceuticals will continue to grow.
Chemical manufacturing giant BASF is building an alkylethanolamine (AEOA) plant at its US site in Louisiana, as increasing American demand pushes the company to increase worldwide production capacities for these important intermediates by 40 per cent.
Warwick Analytical Services has made available a service that allows the investigation and measurement of the optical activity of samples with an accuracy of +/- 0.002 degrees for optical rotations of less than 1 degree.
Finnish packaging company Stora Enso and pharmaceutical group Orion are carrying out a trial of pharmaceuticals packages equipped with RFID (Radio Frequency Identification) tags for every stage of the supply chain using a system that defies the conventional approach of centralisation.
A new laboratory method for distinguishing pathogens from harmless relatives has been developed by scientists in the US. The high-throughput technique will enable the quick identification of pathogens, which could be used for bioterror weapons.
A new study has revealed the existence of new drug targets for tuberculosis (TB) treatments, which could essentially dictate the design of TB drugs of the future. The bacterium that causes TB currently infects one person in three worldwide.
A newly discovered process that explains how the body's nervous system relays information, may depend on how "wet" the "kiss" is when one neuron fires a packet of neurotransmitter across a synapse to a receptive nerve cell.
Last week's approval of Erbitux in the US breaks a 30-year drought in treatments for head and neck cancer, a disease that kills 11,000 people in the US each year. Pharma giant Bristol-Myers Squibb (BMS) and biotech company ImClone Systems are poised to make millions.
British equipment supplier Isopak has launched a new pharmaceutical dosing filler system for powders and granules, quickly and accurately offering the doses required.
Life sciences firm Cambrex has reported a $140.3m (€116.7m) loss in Q4 as opposed to a profit of $4.9m in Q4 last year, hit by lower long-term profitability projections for its Biopharma unit, as biotech companies seem to lose their appetite for outsourcing.
Japan's fourth-largest pharmaceutical company, Eisai, has announced plans for a new pharmaceutical production and formulation research and development facility in North Carolina in anticipation of its parenteral and intravenous oncology treatments.
Stericycle, the largest provider of medical waste management services in the US, has stretched its reach across the Atlantic, completing the acquisition of Ireland's Sterile Technologies Group.
Rising prices globally have helped Dutch chemicals manufacturer DSM go back to profit in Q4, up to €112m (€134m) from €3m in the red a year ago, with operating profits in its Life Science division almost doubling to €39m, albeit thanks to savings not sales.
Complete data analysis in the time it takes many laboratories to take the first steps. This is what Ambion is offering with its new microRNA expression profiling service, claimed to surpass any similar offerings in the market.
Transdermal science specialist Sontra has introduced an upgrade to its ultrasonic skin permeation system, making the application of anaesthesia even more comfortable and less painful for the patient.
Dutch life science firm PharmaCell has hired quality control specialist Sensitech for the cold chain management of their cell culture products, allowing it to ensure compliance with GMP regulations.
India is suddenly a safer place to research and manufacture pharmaceuticals, thanks to legal reform, raised manufacturing standards and reduced bureaucracy. But risk still lurks in the loopholes and protectionism.
Looking to expand the outsourcing services it provides, AmerisourceBergen has snapped up Canadian drug distributor Asenda and British pharmaceutical contract-packaging manufacturer Brecon, indicating the aggressive strengthening of the firm's portfolio in the pharmaceutical supply chain.
Millipore, a maker of purification systems used in drug manufacturing, has expanded its range of hydrophilic Polytetrafluoroethylene (PTFE) membranes, enabling it to offer filters for virtually all solvents, acids, and alkaline solutions.
French firms PCAS and Proteus have decided to pool their expertise to create a new biotech company which will provide APIs and intermediates on a large scale, looking to offer new products and also capitalise on the growing demand for generics.
Britain's Department of Health has awarded healthcare company Baxter and biotech firm Chiron two contracts worth £33m (€48m) in total for the production of around 3.5m doses of H5N1 influenza vaccine, underlying how worldwide concerns about bird flu are offering new opportunities to vaccine manufacturers.
West Pharmaceutical Services reported a sales increase of 28 per cent to $700m (€590m) in 2005, boosted by $100m worth of new business.
The rejection by the European Medicines Agency (EMEA) of ATryn has given the biotech industry some unappetising food for thought.
California-based Electronic Sensor Technology, provider of fast vapor analyzers, is benefiting from recent restrictions in California Air Quality and Nuisance Odor laws that require bad-odor-causing industries to measure and control their emissions.
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