The Brazilian Government is to fund a new facility to produce the Protalix-Pfizer Gaucher's disease drug Uplyso as part of a supply and tech transfer deal worth $280m (€212m).
Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.
Ambrx and Zhejiang Medicine have selected Wuxi to accelerate the development of a potential ADC (antibody drug conjugate) targeting Her2-positive breast cancer.
Lonza has launched a service to help biopharmas decide if promising protein drug candidates are worth developing, from an immunogenicity and manufacturing standpoint.
Catalent says customers are applying controlled release technology to transform drugs into better treatments across all stages of development as it expands its Kentucky manufacturing site.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
The Japanese joint venture between Dr. Reddy’s and Fujifilm has been called-off though both say future collaboration remains likely, especially in API production.
BD says its new quality by design glass prefillable syringe offers added safety in delivering biologics as the industry continues to shift toward biotechnology.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
Early clinical research organisation Celerion has added a containment room to its UK facility in response to client demand for live biologics and vaccine studies.
Hepregen has agreed to provide US CRO QPS Holdings with long-term liver cell models to aid its offerings in drug metabolism and pharmacokinetic (DMPK) services.
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from the MHRA, Achillion and Halozyme.
Over the last decade single-use technologies have moved into manufacturing scales and are increasingly being deployed worldwide, according to Thermo Fisher Scientific.
As Cobra wins a cell line development contract with Recopharma, the firm says its cost-effective gene expression technology has been its biggest growth area.
Scientists at the UK University have developed what they refer to as 'a simple lab-based skin test' which eliminates the risk of adverse reactions to new drugs, cosmetics, and household chemicals.
Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Although preclinical work for CROs has fallen flat in recent quarters, Covance is looking to take advantage of the industry’s shift to early biologic developments and lead optimization.
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
Proposed UK “animal research” labelling laws may backfire if improvements in culture-based toxicology testing continue, according to in vitro CRO Cyprotex.
Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry, including news from Theorem and Symbiosis.
Extra filling capacity is to be made available in preparation for West’s Crystal Zenith (CZ) system, though approval and increased sales are still at least 18 months away.
PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.
Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
Evotec says it is confident underlying growth, expansion of its clinical stage pipeline and upcoming milestone payments will counter Q1’s downcast results.
Melding metals to APIs could make drugs easier to deliver according to Sweden's Recipharm which partnered to add a new chemistry to its offering last week.
In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
New auto-injector technology that is user-friendly and capable of delivering high viscosity drugs may be the next big thing for pharma and biotech companies pushing further into niche biologics and biosimilars.
ASI has teamed up with Chromatan in order to deliver single-use and column-free capture purification services which could save clients 65% in chromatography costs in clinical manufacturing.
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Novartis, Teva and the EMA.
Purification bottlenecks, integrating single-use technologies and low cost companies are just some of the issues affecting the biotech industry today, according to experts at this year’s Interphex.
With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.
A new bipartisan draft bill released by four US senators late last week seeks to establish a lot-level electronic system to track pharmaceutical products and further secure the US supply chain.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
