The Challenge of Change - Managing Excipients Control
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Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.
Changes to manufacturing practices at Genzyme’s plant have led to further shortages of Fabrazyme (agalsidase beta), with production expected to remain below 30 per cent of demand until after June 30.
SAFC Pharma is preparing for the shift towards cell culture-based vaccines, while still supplying and growing in the traditional sector, to ensure it can grow in coming years, according to a company director.
After a period of de-stocking in the first half of 2009, DSM’s nutrition business has weathered the economic slump well; pharma, too, picked up speed towards the end of the year.
In the economic downturn biotechs have cut back on outsourcing to Asia and opted to use the US instead because they lack the resources to manage overseas relationships, according to a SOCMA representative.
The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
NanoGuardian has licensed its NanoEncryption technology to Capsugel, a division of Pfizer, for use as an anti-counterfeiting system on the company’s capsule-based medications.
The aging population is driving manufacturers to develop packaging that is easier to open, while still remaining child-resistant, but this can increase costs and affect sustainability, according to a director.
Helvoet Pharma is to build a €14m ($19m) rubber parenteral packaging component facility in India to meet rising demand for products made to international quality standards.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Noven, Inspire, AP Pharma and Tarsa Therapeutics.
The IPEC Federation has been formed to provide a single voice for the regional councils, Americas, Europe, Japan and China, and promote quality in pharma excipients.
Aesica is looking to acquire manufacturing assets in the US to expand its client base in the country and continue the growth it has maintained throughout the economic downturn.
Genentech has entered into a partnership with the University of California, San Francisco (UCSF), US to further the discovery and development of treatments for neurodegenerative diseases.
There are signs that 2010 will be a better year for the fine and custom chemistry industry but companies at Informex remained cautious and are planning accordingly.
West Pharmaceutical Services reported strong fourth quarter results, underpinned by demand for H1N1 components, but still posted a dip in operating income for its 2009 financial year.
The Chinese API sector shrank last year after a number of high profile quality problems hit demand from Western markets, according to new analysis by outsourcing consultant JZ Med.
US group Aptuit has bolstered its chemistry offering with a new solid state chemistry screen that it says will enable better decisions during drug formulation development and process scale-up.
US group Waters and Japan’s Daiso team up to market bulk process chromatography media and say deal provides the supply stability drug industry demands.
The impact of the economic downturn is still being felt but SAFC remains "cautiously optimistic" about 2010, believing its close relationships with clients and investment in key emerging markets will generate business.
Asian companies have come of age as ingredient suppliers and manufacturers but the region still suffers from promises of unrealistic timelines and a poor supply chain, according to a panel at Informex 2010.
Revenues fell 3 per cent in 2009 at SAFC but pharmaceutical sector demand for vaccine manufacturing products helped firm finish year with six months of growth.
Merck & Co says manufacturing and R&D jobs will go as part of the post acquisition workforce reduction programme it announced yesterday.
Hospira’s acquisition of Orchid Chemicals and Pharmaceuticals generic injectables business is on track to complete next month now the Hart-Scott-Rodino period required by the US Federal Trade Commission has elapsed.
Communication is a vital aspect of the relationship between CMOs, CROs and their clients, with a single point of contact who quickly informs sponsors of problems a necessity, according to a panel at Informex 2010.
Indian drugmaker Elder Pharmaceuticals says its new manufacturing plant in Dehradun, Uttarakhand State will boost sales 15 per cent and provide capacity for expansion in overseas market.
in-PharmaTechnologist presents an exclusive widget that aggregates all the breaking news from Informex 2010 in San Francisco, California, US, including podcasts, articles and tweets from our team at the show.
Counterfeit drugs worth €10.5bn ($14.3bn) are sold in Europe each year with Germans and Italians being the biggest consumers of such products, according to new Pfizer sponsored research.
Rusnano, the group set up to promote Russia’s nanotechnology infrastructure, says nanodrug development partnership will improve patient access and cut cancer death rates across the country.
GEA Niro says new spray drying deal with BASF is an important step in the development of its recently established contract API manufacturing unit.
Capsugel says latest addition to its Xcelodose range, Xcelolab, provides a rapid and reproducible solution for dispensing small amounts of pharmaceutical powders during laboratory stage drug development.
The Sri Lankan State Drug Manufacturing Corporation (SPMC) says it is on track to produce 1.3 billion tablets in 2010 thanks to investment in new production technologies.
Companies are failing to protect their products with tamper evidence but the EU falsified medicine directive, plus the ease of implementation, will drive adoption, according to a director at Schreiner ProSecure.
Generics firm Sohm says deal with manufacturer in Himachal Pradesh doubles capacity, cuts costs 6 per cent and increases profitability.
Cambrex reported a dip in revenues in 2009, citing the timing of orders throughout the year, and warned that smaller clients’ funding difficulties and pricing pressures will continue in 2010.
Using intelligent compliance packaging in clinical trials can result in “huge cost savings” and this will ensure demand even during a period of cost-cutting, according to a sales manager at Stora Enso.
Gerresheimer expects pharmaceutical packaging sales to grow but says performance of “cyclical” cosmetics and life science businesses is more difficult to predict.
US biotechnology firm NexBio has received a patent for “pioneering” host cell-targeting influenza drugs that can cut the risk of viral mutation and the emergence of drug resistant strains.
The WHO has stopped sending free drugs to private hospitals and non-governmental organisations in Haiti after receiving reports that some institutions in the earthquake stricken country had begun to charge patients.
UK drug major GSK will start its programme of R&D cuts at the facility in Harlow, Essex at which it makes pain relief, anxiety and depression drugs.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at GlaxoSmithKline, Synthon, BioSante and Xencor.
Berlin Packaging has agreed to acquire All-Pak, creating a combined company with annual revenues of $500m (€365m) and an expanded geographic, including Puerto Rico.
MDRNA’s liposomal drug delivery formulation, DiLA2, lost no potency when stored for 12 months in conditions ranging from -80ºC to 4ºC, helping to validate it for administration of UsiRNA.
The US FDA says its new screening system will expedite the importation of genuine drugs and help inspectors focus their efforts on “high risk” products.
Almost half of antimalarials in Senegal are substandard, according to a USP study which will be used by local regulators to focus efforts on high-risk products, brands and geographies.
Greater production efficiency, flexibility and state-of-the art capabilities are benefits that lids and shrink sleeve manufacturer Nyco said it can offer after investing in a new hybrid printing press.
The EFCG has welcomed the addition of excipient GMP requirements to the draft amendments of the EU falsified medicines directive but warned that deeper analysis is needed to establish which products warrant further regulation.
Icelandic generics firm Actavis says expansion of its tablet plant will boost production capacity 50 per cent and create 50 new jobs.
ISCO’s stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products.
In a busy week of Big Phama results Pfizer reports sales boost from Wyeth, Roche says Genentech hit profits and GSK unveils surge in Relenza sales and plans to expand R&D restructuring.
Schott AG has launched its InJentle syringe to improve the stability of highly sensitive drugs, which is a “major topic” for the company’s clients, according to a company director.
The US FDA says regulating the safety of drugs will cost $100m more in fiscal 2011 than it will this year, and has asked for a 23 per cent increase in its budget to $4.03bn.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Genzyme strengthening its manufacturing team and Carl Icahn’s representative joining Adventrex’s board.
Pharmadule has teamed up with Morimatsu to capture a share of Chinese pharma and biotech manufacturing markets’ “huge potential.”
Demand for disposable bioprocessing tech helped Millipore to a comfortable Q4, cementing the recovery made by the unit throughout 2009.
Seidenader Maschinenbau has developed a system which can check up to 600 syringes per minute for pierced needle shields.
Pall Life Sciences plans to shake up bioprocessing with a vibration-based filtering tech that can cut costs and simplify process design by combining harvest and clarification in the same system.
Biofem Pharmaceuticals and NAFDAC have launched an anti-counterfeiting pilot project in Nigeria, using a mobile authentication service (MAS) to validate if a medicine is genuine.
Global packaging giant Amcor today announced that its acquisition of Alcan Packaging had been completed as it spelled out what the move would mean for suppliers and customers.
In-PharmaTechnologist presents a round up of recent developments in the field of drug delivery, with new deals for Starpharma and Penwest, and a regulatory filing for Hovione.
Suzhou Erye Pharmaceutical has received SFDA approval to make penicillin at its new manufacturing facility in Eastern China.
Keller-Crescent has acquired Puerto Rico-based Lehigh Press to expand its capacity for producing pharmaceutical labels, inserts and outserts.
US generics group Watson Pharmaceuticals has bought UK contract biomanufacturing specialist Eden Biodesign.
Peakdale Molecular and Pfizer unveil plan set up a synthetic chemistry services group just days after the US major trimmed its pipeline.
Therapure Biopharma has added commercial-scale lyophilisation capacity at its facility Mississauga, Ontario in response to growing demand.
Reports suggest that GlaxoSmithKline (GSK) will announce major job cuts later this week as part of a renewed cost reduction drive.
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