The Challenge of Change - Managing Excipients Control
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SAFC's Mike Harris sets out the firm's role in the expanding high-potency active pharmaceutical ingredient (HPAPI) industry.
Wyeth is cutting back on its early stage R&D efforts to focus on oncology, inflammation, vaccines, metabolic diseases, musculoskeletal problems and neuroscience.
Next year, drug revenues will grow 5 per cent to $820bn according to IMS Health, as the global downturn, patent expiry and flat-lining growth rates in mature markets all make their presence felt.
The Indian state of Orissa and a biotech company have entered into a public-private partnership (PPP) to construct a $20m technology park.
The US Food and Drug Administration (FDA) has issued a warning letter to Pharmalucence for alleged deviations from current good manufacturing practices (cGMP).
India’s Shasun Pharma Solutions is to close its manufacturing facility in Annan, Scotland explaining that the site is being “underused,” according to media reports.
Contracting giant Catalent says its pre-filled syringe facility in Brussels, Belgium has received Food and Drug Administration approval for the manufacture of products for the US market.
The development of insulin-producing cells from human stem cells is to be advanced by a collaborative research agreement involving Novo Nordisk.
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
Bayer HealthCare’s new sterile filling facility (SFF) has been granted license approval by the European Medicines Agency (EMEA).
AngioChem has posted findings that its lead candidate using its propriety technology for crossing the blood-brain barrier (BBB) is safe and well tolerated.
Nuvo Research has presented positive Phase III results for Pennsaid (diclofenac sodium solution), which uses the company’s transdermal drug delivery technology.
The NAFDAC has banned 22 firms that it says are involved in the manufacture of fake drugs from ever again selling pharmaceuticals in Nigeria, as part of a countrywide clampdown.
Agilent and BioTrove have forged a non-exclusive mass spectrometry partnership designed to enhance the screening of candidate drug compounds in early stage development.
Isochem will have manufactured ten tonnes of the multi-purpose drug excipient vitamin E TPGS by the end of the year, marking the end of what it says has been a successful first 12 months of commercial scale production.
Irish drugmaker Elan has shelved plans to sell its contracting arm EDT in favour of improving the division’s profitability, despite receiving what it describes as “considerable interest” in the unit.
in-PharmaTechnologist.com presents its latest round up of personnel moves in pharmaceutical manufacturing, including major restructuring at Novartis.
Sun Pharmaceutical has posted a strong set of results for the second quarter of fiscal 2009, driven by improved performance by both its Indian branded drug and US generics businesses.
David Hipkiss explains the benefits for pharmaceutical manufacturers of using Prosonix’ sonocrystallisation technology.
The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.
Merck & Co plans to cut 7,200 jobs, joining the growing list of big pharma firms enacting restructuring measures in the face of falling earnings and an uncertain market future.
French drug giant Sanofi-Aventis has set its sights on developing China as its Asian R&D hub, unveiling plans for a significant expansion of its clinical research unit in Shanghai.
Researchers have developed a self-assembling hydrogel, which they claim is biocompatible, easy to tailor and efficient at releasing drugs.
A report has been published detailing the US Food and Drug Administration’s (FDA) failings in its inspection of overseas manufacturing facilities.
Ethex has withdrawn three lots of its generic drug dextroamphetamine sulphate, which is used to treat ADHD and narcolepsy, after analysis revealed that some oversized tablets had been produced.
India’s reputation as a base for quality, low-cost drug manufacture has proved irresistible for yet another big pharma company with Japan’s Eisai unveiling plans for a new production and R&D facility.
3M’s drug delivery division and US biotechnology firm VaxInnate have teamed up to develop transdermal influenza vaccine delivery patch in preparation for the anticipated pandemic.
NovaDel Pharma has secured $2.5m in financing, some of which will be used to further use of its proprietary drug delivery technology.
Pfizer and Schering-Plough have both exceeded their earnings estimates, although this was largely underpinned by favourable exchange rates and low expectations.
Welcome to in-pharma technologist’s podcast. In the next three minutes Gareth Macdonald will take you through the top industry headlines this week. Product authenticity dominated the news, with US regulators announcing increased penalties for those convicted of selling dangerous counterfeits. In Europe IPEC sets out its new third party assessment scheme.
Bend Research is offering companies some of the drug delivery formulation expertise and technologies it developed during its 23 year collaboration with Pfizer.
US FDA approval for Teva’s transdermal fentanyl patch ushers the Israeli generics giant into the potentially lucrative but often problematic chronic pain therapy sector.
Sartorius Stedim Biotech (SSB) and Bayer Technology Services (BTS) have signed an exclusive cooperation agreement for the manufacture and marketing of UVivatec products.
Novartis has acquired Nektar Therapeutics’ pulmonary drug delivery business for $115m, with further takeovers possible in the foreseeable future.
A UK company has been launched with the aim of providing high level management expertise to pharmaceutical companies on an “on-demand” basis.
in-PharmaTechnologist.com presents its latest round up personnel changes in the pharmaceutical sector.
ONI BioPharma has produced an antibiotic using its DPOLT technology, a solid phase synthesis platform for manufacturing bioactive peptides.
Covidien hopes that a $100m (€74m) expansion of facilities at its production hub in St Louis, Missouri, US will boost efficiency and cut the time it takes to bring products to market.
The European Parliament has voted in favour of incorporating the United Nations’ (UN) Globally Harmonised System (GHS) for chemical packaging into EU law.
The FAMAC Division of Pöppelmann has launched a new range of plastic tubes for applications in the pharmaceuticals and food industries.
German contract services firm InfraServ Knapsack has added three new capabilities in its analytical division aimed at servicing Good Manufacturing Practice (GMP) production.
Hameln Pharma has been granted a manufacturing license for its brand new sterile manufacturing plant, the result of a €35m investment programme which has almost doubled the contract manufacturer’s capacity.
UK contract manufacturer Specials Clinical Manufacturing has added to its portfolio of capabilities with two new services – radiopharmaceuticals and biologics.
Hermes Pharma of Germany is planning to boost its manufacturing capacity for effervescent tablets by 50 per cent with a €35m investment at its facilities in Wolfratshausen and Wolfsberg.
Fine chemical company Univar has constructed a network of suppliers for paracetamol (also known as acetaminophen) to avoid shortages following the closure of the last plant making the ingredient in Europe.
The relentless commoditisation of glycerine ingredients prompted Dow Chemicals to all but exit the sector a few years back, but now the company says it is seeing a resurgence for its flagship synthetic glycerine brand.
Gerresheimer’s decision to concentrate on the pharmaceutical and life science sectors and sell-off non-core divisions appears to be paying dividends judging by a 14 per cent jump in third quarter operating profit.
Wyeth Medica, an Irish subsidiary of US drugmaker Wyeth, plans to cut 250 jobs at its manufacturing plant in Newbridge, County Kildare, according to media reports.
Merck & Co has completed start-up activities at its vaccine manufacturing plant in Durham, North Carolina, which is intended to further the company’s ambitions in the sector.
US drugmaker Par Pharmaceuticals is wielding the axe at its generics division, cutting 190 jobs and refocusing its R&D efforts on the completion of its current roster of product candidates
A new avenue of inquiry has been opened in the investigation into the US Food and Drug Administration’s (FDA) ability and commitment to protect the nation’s citizens from unsafe drugs.
US President George W Bush has signed a bill under which counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual.
in-PharmaTechnologist.com presents its latest round up of developments in drug delivery, including Philips first foray into drug delivery and a licensing deal for 3M.
The MicroSEQ detection platform, developed by Applied Biosystems, looks set to revolutionise the detection of bacterial Mycoplasma in industrial scale biopharmaceutical manufacturing.
US company Ferro has said it will sell off its fine chemicals division to private equity firm Arsenal Capital Partners, which will rename the business as Novolyte Technologies, for $66m.
With big pharma and biopharma looking to cut costs and increase efficiency, liquid handling experts Artel have found that their services are in greater need than ever before.
Draft guidance for testing the potency of cellular and gene therapy products (CGTs) has been issued by the US Food and Drug Administration (FDA).
International Specialty Products has extended its portfolio of polymer coatings with the launch of a new range – Advantia Preferred HS – intended as immediate-release films for oral solid dosage forms.
Moorfields Pharmaceuticals, a contract manufacturer based at the Moorfields Eye Hospital in London, UK, has boosted its ability to provide materials for Phase I clinical trials by installing a Rommelag 3012M for ampoule filling.
Dutch sample and assay technology expert Qiagen has continued its march into the detection system market with the acquisition of Biotage’s Biosystems business.
The 2008 Nobel Prize for Chemistry has been awarded equally to three chemists "for the discovery and development of the green fluorescent protein (GFP),” one of the most important tools in bioscience.
A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.
API maker Cody Laboratories is targeting the lucrative analgesic and pain management markets with a new process that improves the efficiency of hydromorphone and hydrocodone manufacture.
The implementation of California’s ePedigree system has been knocked back yet again, with 1 January 2015 now the proposed date.
The scientists who discovered the viruses responsible for causing AIDS and cervical cancer have been honoured with the 2008 Nobel Prize in Physiology or Medicine.
GE Healthcare’s range of AxiChrom columns will simplify manufacturing operations, improve reproducibility and allow for faster change over according to company senior product manager, Per Karlberg.
Industrial polymer firm Arkema hopes that Kynar Rx, a new grade of its widely used Kynar resin technology, will help it corner the market for single-use sterile manufacturing applications in the bioprocessing sector.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
Dow Chemical is hoping to push production of its Carbowax Sentry brand of polyethylene glycol ingredients up by a third over 2006/2007 levels by the end of the year, and put the production problems of recent months behind it.
Packaging firm Chesapeake has become a visible casualty of the current economic climate, with the New York Stock Exchange (NYSE) suspending trading of its shares.
The UK launch of Eli Lilly’s pre-filled insulin device Humalog KwikPen offers the country’s 800,000 insulin-dependant diabetics a simplified treatment option, according to company development director Stuart Breslin.
BioVigilant says that two type V DMFs for its IMD-A rapid microbial detection system, which it has filed with the US FDA, can now be referenced by clients hoping to use it in drug manufacture, potentially reducing review times.
BASF introduced new catalysts designed to replace environmentally-unfriendly alternatives based on lead at the CPhI show in Frankfurt last week.
Ahead of the “open house” at its facility in Monteriggioni, Siena, Italian machining specialist Marchesini spoke with in-PharmaTechnologist.com about the new plant and its role in the firm's offering to the drug industry.
Alcan says that its new Indian facility further strengthens its position “in pharmaceutical flexibles through growth in emerging markets,” which contributed about 20 per cent of its revenue last year.
Khandelwal Laboratories use of silver nanotechnology as an antimicrobial was nominated for this years innovation awards at CPhI.
in-PharmaTechnologist.com’s latest round up of developments in drug delivery includes Critical Pharmaceuticals’ sustained release hGH, Phase III results for AP Pharma and nanodiamonds.
Eli Lilly has agreed to acquire ImClone for $6.5bn and in doing so appears to have snatched the biotech away from Bristol-Myers Squibb (BMS), which first tabled a bid back in July.
PharmAthene has stated its desire to compete for a government anthrax vaccine manufacturing contract, which could be worth up to $600m.
Two chemical company directors have been sentenced for not notifying authorities that their company produced a substance controlled under the Chemical Weapons Convention (CWC).
in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Malvern, Caen, Finesse and Bausch.
AkzoNobel has been awarded a good manufacturing practice (GMP) certificate for Sanal (sodium chloride) salt manufactured at its plant in Mariager, Denmark.
Bio-Rad has published new results showing how its ProteOn XPR36 protein interaction array system can dramatically speed up monoclonal antibody (mAb) screening.
GE Healthcare has bought label-free molecular interaction analysis expert MicroCal to bolster its label-free analysis offering to life science and pharmaceutical customers.
Novozymes Biopolymer’s novel hyaluronic acid (HA) HyaCare has been named winner of this year’s gold innovation award at the CPhI worldwide conference in Frankfurt, Germany.
in-PharmaTechnologist.com presents its latest round-up of personnel changes in the pharmaceutical manufacturing sector.
Pfizer is shifting its research focus to those diseases where its sees the potential for the biggest treatment improvements and profits, while dropping eight disease areas including cholesterol.
French firm Novasep has significantly boosted its ability to provide customers with enantiomerically pure compounds with the addition of a new chiral chromatography unit.
India’s Sun Pharmaceutical has installed a 3D imaging system from FEI Company to speed up the development of new therapeutics and aid its quality control processes.
Good Products and Adlib Software have teamed up to create a streamlined and compliant regulatory document management system for the pharmaceutical industry.
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