The Challenge of Change - Managing Excipients Control
Colorcon
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GSK and Pfizer’s HIV joint venture (JV) may be subject to an investigation by UK competition watchdog the Office of Fair Trading (OFT), according to various media reports.
Spire has received a patent for its nanophotovoltaic devices, which it believes could be injected into a tumour, be activated by light and generate electric fields to disrupt the cancerous cells.
Schlafender Hase has launched a new version of its text verification tool (TVT) that supports all major languages, allowing pharma packagers in all regions to check labels prior to shipping.
NanoGuardian has partnered with SDI to deliver Closed-Loop Protection, which combines on-dose authentication and tracing with a pharmacy monitoring programme to stop counterfeit pharmaceuticals entering the supply chain.
Sanofi Pasteur, the vaccines unit of French drug major Sanofi Aventis, has received a reference strain of the H1N1 swine flu virus from the US CDC and expects to complete work on an industrial “seed stock” in the next two weeks.
Stiffer penalties for counterfeiters could be counterproductive in less developed countries (LDC) and “entrench the corrupt symbiotic relationship between counterfeiters, lawmakers and officials”, according to a report
Ranbaxy CEO Malvinder Singh has left the troubled drugmaker just seven months into a five year contract awarded by Japanese owner DaiiChi Sankyo.
Wacker has brought its expanded cyclodextrin facility online following its $21m (€15m) expansion, which has significantly increased capacity in response to growing demand for the excipient.
Nguyen Tan Dung, Prime Minister of Vietnam, has approved plans to develop the country’s pharma raw material capacity by building six chemical plants and two laboratories, according to media reports.
FIT Biotech has entered into a partnership that will see its GTU MultiHIV DNA plasmid developed using ImmunoVaccine Technologies’ DepoVax delivery tool, which uses liposomes to encapsulate a target antigen and adjuvant.
Sanofi Pasteur has landed what it believes will be the first of a series of orders from the US Department of Health and Human Services (HHS) to produce H1N1 vaccines.
At BIO 2009 Cobra Biomanufacturing explained to Outsourcing-Pharma its maxXpress service, its thoughts on expanding to commercial scale and the recent deal with KAHR Medical.
CMO Richter-Helm BioLogics has achieved a 60 per cent increase in yield using technology from Upfront Chromatography, which demonstrated its system at BIO 2009.
Peru’s National Center for Quality Control (CNCC) has attained ISO/IEC 17025:2005 accreditation, furthering its safety efforts and becoming one of the few Latin American countries to achieve this.
Singapore’s prudent spending means it can view the economic crisis as an opportunity, according to an executive director of its EDB, using saved funds to progress beyond its struggling rivals.
in-Pharmatechnologist's Nick Taylor looks back on BIO 2009, an event at which uncertainty about the development of the biotechnology industry’s future shape dominated proceedings.
Portuguese contract manufacturing organisation (CMO) Hovione plans to invest €2m ($3m) in a new R&D unit in the capital Lisbon, as expansion space at its active pharmaceutical ingredient (API) plant in Loures is limited.
Teva and Lonza have had their biosimilars joint venture approved by the European Commission, clearing the way for the companies to collaborate on development and manufacture.
in-PharmaTechnologist presents an exclusive interactive map of all the FDA registered facilities of 30 of the pharmaceutical industry’s major players, giving a unique geographical oversight.
Karl Rove and Senator Tom Daschle were among the political figures at BIO 2009 discussing how the US healthcare system should be reformed, which some believe could have grave consequences for medical innovation in the country.
HEM Pierre Vimont, Ambassador of France to the US, was at BIO 2009 talking about the measures his nation have taken to attract biotechs, including the introduction of the "most favourable R&D tax in Europe".
HEM Pierre Vimont, Ambassador of France to the US, was at BIO 2009 discussing the measures his nation have taken to attract biotechs, including the introduction of the "most favourable R&D tax in Europe".
Fine chemicals firm Minakem believes that manufacturing capacity added by its newly acquired API plant in Dunkirk, France will reduce costs and help it compete on a global scale.
Piramal Healthcare’s new clinical trial manufacturing, packaging and distribution centre in Northumberland, UK will help pharma industry customers to “build cost saving at an early stage,” according to European strategic manager Martin Hunt.
In a session chaired by at BIO 2009 John Lechleiter, CEO at Eli Lilly, speakers discussed patent reform, biosimilar bills and why certain options on the table could be a "stake in the heart" of the biotech industry.
Archimedes Pharma has presented positive Phase III results of its treatment for breakthrough cancer pain, NasalFent, which uses the company’s PecSys delivery technology.
Freeman Technologies, which showcased its FT4 Rheometer at Achema in Frankfurt, Germany, last week, says pharmaceutical powders are complex systems that require analysis of multiple parameters.
Telstar unveiled a range of products at Achema 2009 in Frankfurt, Germany last week, including its compact unloading system that forms part of its automatic vial loading system and aims to minimise installation space.
in-PharmaTechnologist assesses the scale of the challenge facing the FDA in effectively monitoring overseas facilities, using interactive graphics and textual analysis.
in-PharmaTechnologist presents its latest round up of movements in the pharmaceutical sector, including job changes at Novartis and Mylan.
A US FDA investigation of two deaths and a case of intercranial bleeding at the Beebe Medical Center in Lewes, Delaware has found no link to a batch of the blood thinner heparin made by Baxter International.
US drug firms’ qualification of overseas API vendors will be subject to increased FDA scrutiny in the coming years according to a new industry report by analysts Hogan & Hartson (H&H).
A new 9,500 unit per hour sterilised syringe filler was a highlight of Bosch Packaging Technology’s busy programme of machine launches at Achema 2009 in Frankfurt, Germany this week.
ExcellGene’s OrbShake 250L mammalian cell culture bioreactor has equalled biomass productivity and oxygenation levels previously only achieved by traditional stirred tank systems.
Sanofi-aventis is has made its largest ever investment in its vaccine capacity, using €350m ($479m) to construct a dengue fever vaccine manufacturing plant in France.
Pharmaceuticals with a street value of €2m ($2.7m), including 83,000 tablets of the “date rape” drug flunitrazepam, have been stolen from a North Dublin-based drug warehouse, according to reports in the Irish media.
A new $60m (€43m) manufacturing suite is operational at the South Carolina, US plant where Roche makes APIs for some of its leading products, including for its anti-flu drug Tamiflu (oseltamivir).
Baxter International says Pfizer supplied the bulk API used in a batch of Heparin linked to two patient deaths in Delaware, US last week, amid concerns of a repeat of last year’s contamination scandal.
GlaxoSmithKline (GSK) is to take a 16 per cent stake in Aspen in exchange for a manufacturing facility and eight medicines, building on the companies’ relationship and the big pharma’s profile in Africa.
Cambridge Consultants has developed its ‘connected patient’ technology, which creates a communication network between drug delivery devices and healthcare professionals to increase compliance.
The FDA plans to increase field tests in imported drugs by over 100 per cent and has requested a 19 per cent rise in its budget for 2010 to enable it to achieve this and other targets.
Biotechnology group Genzyme will boost biomanufacturing capacity at its plant in Geel, Belgium in a move that is “fundamentally important to future growth” according to site VP Sandra Poole.
Italian machining specialist Marchesini’s claims its new 150 carton per minute Unica monobloc packaging system offers syringe makers greater packaging flexibility, improved cleaning access and quicker change over.
A new ready-to-use WFI prefilled syringe for the reconstitution of lyophilised drugs is likely to win fans among producers of high-value biopharma drugs according to West Pharmaceutical Services’s VP of European marketing, Mike Schaefers.
Agilent has completed the second expansion of its nucleic acid active pharmaceutical ingredient (API) manufacturing facility, which is intended to meet rising demand for oligonucleotide-based drugs.
US chemistry firm PharmaTek Laboratories has a green light to start making high potency APIs and cytotoxics at its facility in California after meeting strict safety and control rules that govern their production.
Medica Packaging is upgrading its label inspection capabilities through the installation of three Surfscan Technologies systems, which should eliminate customer returns by detecting defects.
Millipore has launched its single-use ChromaSorb membrane adsorber, which binds negative impurities from host cell protein (HCP), DNA, endotoxins, and viruses at high salt concentrations.
SurModics has completed the three year Phase I trial of I-vation TA (triamcinolone acetonide), which uses a novel drug delivery system capable of sustained ocular release of a therapeutic.
Drug delivery specialist Hospira has set up a “biologics clock” that counts the amount spent on cell culture-derived medications in the US in a bid to highlight the potential savings greater use of generics could provide.
Copley Scientific is expanding its range of nebuliser testing equipment by launching its NGI Cooler, which has been developed in light of suggested revisions to aerosol monographs on both sides of the Atlantic.
Creative thinking is required by biotechs if they are to stay afloat despite the lack of funding, according to a report by Ernst & Young, and this could reshape the landscape of the industry.
Venezuela has inaugurated a state funded pharmaceutical manufacturing facility and allocated resources for a new complex as part of the nation’s attempts to provide subsidized drugs to citizens.
French drug major Sanofi Aventis has unveiled plans for a €200m ($268m) biotechnology investment at its manufacturing facility in Vitry-sur-Seine near Paris, under its collaborative Biolaunch project.
Pharmafreight and Kryotrans have teamed up to offer a one-way, temperature-controlled shipping service that they claim will help pharmaceutical exporters cut costs and boost efficiency.
in-PharmaTechnologist presents its latest round up of movements in the pharmaceutical sector, including appointments at Pfizer and Novo Nordisk.
Contract pharmaceutical services provider Catalent is to install a 10 colour press at its printed components facility in the Irish capital Dublin as part of a company wide effort to expand European operations.
Axentis Pharma has received orphan drug designation (ODD) in the US for its cystic fibrosis treatment, which uses liposomes to deliver prolonged high-concentrations of a therapeutic to the infected area.
Two recombinant human albumins made by Novozymes' biopharma division have become the first to comply with the USP-NF's recently revised excipient monograph.
German industrial phosphate maker Budenheim has been certified to produce calcium phosphates as pharmaceutical excipients under ICH Q7A GMP guidelines.
Greek authorities have banned the export of the anti-virals Relenza and Tamiflu to prevent the country’s stockpile being sold off through parallel trade as global demand for the drugs increases on concerns about a H1N1 influenza pandemic.
Suspicious spikes in the trading of Schering-Plough shares prior to its merger with Merck & Co are being investigating by the SEC, according to media reports.
Althea Technologies’ biologics and injectables contract development, manufacturing and testing facility in San Diego, US is open for business, bringing to an end the firm’s two year campaign to expand capacity.
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