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MDRNA’s formulation stable after 12 months

09-Feb-2010 - 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.

ISCO stem cell production site passes building inspection

08-Feb-2010 - 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.

Deals dominate developments in drug delivery space

02-Feb-2010 - 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.

News in brief

Suzhou Eyre cleared for penicillin production by SFDA

02-Feb-2010 - Suzhou Erye Pharmaceutical has received SFDA approval to make penicillin at its new manufacturing facility in Eastern China.

Lonza hit by lower demand last year; cuts capex in 2010

28-Jan-2010 - Full-year income at the Lonza was hit by falling demand for life science ingredients and custom manufacturing services and only modest gains for its bioscience unit.

Crospon spins out transdermal patch

28-Jan-2010 - Crospon has spun out its transdermal controlled release patch into a distinct company, two years after it licensed the system from HP, using funding from a pharma firm to further its development.

Environmental sustainability should be built into GMP; MPA

27-Jan-2010 - Environmental certification of production facilities should be introduced to GMP legislation and sustainability risk assessments linked to marketing authorisations, according to a MPA report.

News in brief

Copley launches world’s first dissolution tester for inhaled drugs

27-Jan-2010 - Copley Scientific claims new dissolution testing apparatus is first commercially available device specifically designed for inhaled drug formulations.

Merck KGaA to expand inorganic salts capacity 50%

27-Jan-2010 - Merck KGaA has begun work on a new inorganic salts plant in Darmstadt, Germany, citing growing demand as the main motivation for the €30m ($42m) investment.

New network aims to enhance formulation collaboration

26-Jan-2010 - The Formulation Innovation Network has been set up in the North of England as a means of enhancing innovation for all formulation-orientated businesses.

LTS teams up with IntelGenx on VersaFilm

26-Jan-2010 - LTS Lohmann Therapie-Systeme (LTS) signs up as manufacturer of drugs that use IntelGenx’s VersaFilm delivery technology.

SurModics opens 90,000 sq ft site

25-Jan-2010 - SurModics has opened a 90,000 sq ft cGMP manufacturing and development facility in Birmingham, Alabama, US to support its partnerships and shorten time to market.

News in brief

Dr Reddy’s licenses Aegis’ drug delivery tech

25-Jan-2010 - Dr Reddy’s Laboratories is combining some of its products with Aegis Therapeutics’ Intravail drug delivery technology after the companies entered into a partnership.

AMRI plant gains SafeBridge HPAPI certification

21-Jan-2010 - AMRI’s plant in Rensselaer, New York gained SafeBridge potent compound certification this week after an effort that spokesperson Andrea Schulz said istestament to the firm's "willingness to go the extra mile”.

Lupin's Mandideep plant OKed by US FDA

21-Jan-2010 - Indian drugmaker Lupin can start seeking US approval for new drugs made at its API plant in Mandideep, Bhopal after resolving the cGMP deficiencies that earned the facility a US FDA warning last year.

News in brief

Ocelus gets funding for needle-free tech

20-Jan-2010 - Ocelus’ has received £500,000 from Finance Wales and the Welsh Assembly Government to fund the development of its Microplant Delivery System.

Access’ oral insulin shows preclinical promise

20-Jan-2010 - Access Pharmaceuticals’ insulin diabetes treatment has shown promise in preclinical trials, achieving over 80 per cent oral bioavailability, leading the company to target proof-of-concept studies in humans.

Ranbaxy buys Biovel to strengthen in biologics and vaccines

20-Jan-2010 - Ranbaxy Laboratories has strengthened its vaccine and biologics manufacturing capabilities by acquiring India-based Biovel Lifesciences.

News in brief

SVF divests stake in Shilpa

18-Jan-2010 - Strategic Ventures Fund (SVF) has divested its stake in API producer Shilpa Medicare after four years invested in the company, during which time it has doubled its manufacturing capacity.

Lonza to close Riverside API plant

14-Jan-2010 - Lonza will shut down its API plant in Riverside, Pennsylvania, US by the end of the year as part of a plan to cut costs and shift small-molecule production to Asia.

News in brief

Cel-Sci validates manufacturing facility

13-Jan-2010 - Cel-Sci has completed validation of critical utilities and production equipment at its GMP facility which uses cold 4ºC aseptic filling to improve the shelf-life and potency and biologics.

Novavax scales up RSV-F vaccine

13-Jan-2010 - Novavax has completed cGMP scale up of its RSV-F vaccine candidate, with the material being used in preclinical studies, and amended the terms of the H1N1 collaboration with Xcellerex.

Florida Biologix expands bioreactor and fill capacity

11-Jan-2010 - A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.

News in brief

API production starts at Evonik's new plant

11-Jan-2010 - Production has begun at the US API plant German chemicals firm Evonik Industries recently bought from drugmaker Eli Lilly.

Insect cells could cut vaccine production to 10 weeks

11-Jan-2010 - Vaccines could be produced in less than 10 weeks from first isolation of the RNA sequence by using insect cell derived influenza VLPs, according to research which has implications for H1N1 and H5N1.

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