Business Wire

Quotient Sciences Significantly Expands Formulation and Manufacturing Operations in U.K.

Del

Quotient Sciences, a leading drug development services organization, has significantly expanded its formulation development and clinical trial manufacturing operations at its Reading, U.K., facility. The program’s investment has tripled the site’s GMP capacity, added new equipment for solid oral dose manufacturing and significantly increased staffing levels.

“Our investment in Reading is in direct response to increasing client demand,” said Mark Egerton, CEO of Quotient Sciences. “With drug development expertise on both sides of the Atlantic, we are optimally positioned to serve our global client base. The Reading site can support customers with stand-alone formulation and clinical trial manufacturing services that can also be integrated into Translational Pharmaceutics® programs.”

Activities at the 48,000-square-foot Reading facility are focused on small molecule drug products for oral and inhaled delivery spanning drug substance characterization, formulation development and clinical trial manufacturing. The site routinely handles poorly soluble compounds and is equipped with a broad range of technologies including spray drying, hot melt extrusion, lipidic systems and micronization.

Its capacity is bolstered by 13 GMP manufacturing suites to support traditional Phase I-III clinical trial manufacturing and Translational Pharmaceutics programs that integrate real-time adaptive manufacturing and clinical research. This flexible and nimble approach allows batch sizes to be tailored to the precise needs of a clinical trial. Drug products are rapidly supplied into global patient trials and clinical pharmacology units, delivering substantial benefits to customers including flexible dose adjustments, reductions in manufacturing costs and shorter manufacturing lead times.

Quotient has more than 800 employees across six operating sites in the U.K. and U.S., serving a global customer base of more than 150 biotech and pharma clients.

About Quotient Sciences

Quotient Sciences, a global pharmaceutical development, clinical pharmacology and clinical and commercial manufacturing organization, delivers innovative, customized solutions for pharmaceutical and biotech customers through both individual and integrated services. Its Translational Pharmaceutics® platform integrates formulation development, real-time adaptive GMP manufacturing and clinical research for the continuous improvement of drug development programs, and is proven to accelerate timelines and reduce cost. Visit quotientsciences.com.

Contact information

SCORR Marketing
Jane Byram, +1-512-626-2758
jane@scorrmarketing.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Game of Thrones Winter is Coming™ Launches Worldwide25.3.2019 23:00:00 CETPressemelding

Yoozoo Games, a leading game developer and publisher, today announced the global launch of Game of Thrones Winter is Coming™ , a real-time strategy PC browser game officially licensed by Warner Bros. Interactive Entertainment under license from HBO®. The game is now available in English, with additional languages to follow. HBO, Warner Bros. Interactive Entertainment and Yoozoo Games have collaborated to recreate Westeros on a massive scale, delivering an authentic and immersive multiplayer world laid out across the Seven Kingdoms – complete with major landmarks and castles from the epic TV series. The story begins immediately following the death of Eddard Stark, when the player emerges as a new Westeros lord or lady in his stead. Strategising starts in earnest in Game of Thrones Winter is Coming as players aim to build an impenetrable base, train a victorious army and recruit faithful followers from a pool of iconic characters. As players progress, they must continue to acquire the mi

Earth Networks Announces Completion of Severe Weather Early Warning System for PAGASA25.3.2019 23:00:00 CETPressemelding

Earth Networks announced today the completion of the Philippines’ first nationwide severe weather monitoring and alerting network with associated software services for the Philippine Atmospheric, Geophysical, and Astronomical Services Administration (PAGASA), the National Meteorological and Hydrological Services (NMHS) agency of the Republic of the Philippines. The announcement was made at the 6th annual InterMET Asia conference in Singapore. Initiated in 2017, and formally commissioned this week, the technology partnership between PAGASA and Earth Networks is the first of its kind in the Philippines and surrounding regions, powered by a network of total lightning sensors and real-time automatic weather stations for mesoscale monitoring. Installed and operated together with Philippines partner West Point Engineering, the 10-year program includes: Real-time lightning detection powered by the Earth Networks Total Lightning Network On-the-ground weather monitoring via the Earth Networks W

bluebird bio Statement on European Regulatory Status of LentiGlobin™25.3.2019 22:40:00 CETPressemelding

A third party press release was issued today stating that the EMA (European Medicines Agency) issued an approval for the conditional Marketing Authorization Application (MAA) for LentiGlobin™, bluebird bio’s investigational gene therapy for the treatment of transfusion dependent β-thalassemia (TDT). LentiGlobin for TDT is scheduled to be reviewed as part of the CHMP (Committee on Human Medicinal Products) meeting from March 25 – 28, however no opinion has been issued by the CHMP. If the CHMP’s opinion is issued it would then be reviewed by the European Commission (EC), which has the authority to grant approval for the use of LentiGlobin in the EU. About bluebird bio, Inc. bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, we’re developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, we’re working

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis25.3.2019 20:30:00 CETPressemelding

Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The pivotal efficacy and safety data provided in the application result from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials. “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in

AVLT and UKTS Announce the European Medicines Agency’s Approval of the Conditional Marketing Authorization Application for Zynteglo™ (Previously Known as Lentiglobin™) Gene Therapy for the Treatment of Transfusion Dependent Beta Thalassaemia25.3.2019 19:50:00 CETPressemelding

Associazione Veneta Lotta alla Talassemia (AVLT) and the UK Thalassaemia Society (UKTS) announced today that the European Medicines Agency (EMA) has approved bluebird bio’s application for Conditional Marketing Authorization (cMAA) of their product Zynteglo™, a gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassaemia (TDT) who do not have a β0/β0 genotype. As a result of this marketing authorisation, Zynteglo™ is now approved for use in all European countries covered by the European Medicines Agency. Zynteglo™ has been given ‘conditional authorisation’. This means that there is more evidence to be submitted, which the company is required to provide under specific obligations. Every year, the EMA will review any new information that becomes available. “People living with transfusion-dependent β-thalassaemia have a reduced life expectancy, requiring life-long frequent blood transfusions that are life-saving but may lead to complications, includin

Historic Partnership between the Weizmann Institute of Science and Institut Curie25.3.2019 16:54:00 CETPressemelding

On March 22, the Weizmann Institute of Science in Rehovot, Israel, and Institut Curie in Paris, France, two major world-class research institutes, signed an historic partnership that will allow their teams to work closely together to improve knowledge in the field of life sciences, particularly in the areas of physics and chemistry, and most specifically - in the field of cancer research. This is a milestone in the history of these two institutes that have been working together for 15 years, particularly in the field of biophysics. Collaborative research programs This partnership will extend to many disciplines, including physics, chemistry, cellular biology, epigenetics, genetics, immunology and single cell approaches, imagery and data collection. The complementarity of the research between the various groups at Institut Curie and at the Weizmann Institute has been recognized in particular at the occasion of joint scientific workshops held regularly alternatively in Paris and Rehovot.