CUSTOM SERVICES


Partnership to accelerate biopharma R&D and manufacture


US company Theorem Clinical Research and Gallus BioPharmaceuticals have entered into an exclusive partnership in which Gallus will provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to Theorem’s customers. In return, Theorem will offer contract research services to Gallus’ customers to increase both companies’ global reach and accelerate their customers’ products through the clinic to market. The two companies said that by combining contract research organisation (CRO) and contract development and manufacturing organisation (CMO) activities, product development becomes more easily managed and more efficient and that their


collaboration is aimed at addressing this issue and


suppor the needs of their customers in the research, development and


25 years of experience in process development and more than ten years’ experience in commercial manufacturing. Its facilities are designed to support the development of early-phase processes through to scale-up and full clinical and commercial production.


DavosPharma in novel therapeutics agreement


DavosPharma has formed an agreement with The Wistar Institute of Philadelphia to provide DMPK and preclinical IND-enabling studies and logistical


“Theorem says that many of its customers, especially those in Asia, need


manufacturing assistance in the US market and that its partnership with Gallus will ensure they receive the


service required for them to advance their trials and prepare for submission success”


commercial production of new biopharmaceuticals.


Theorem provides core CRO services for Phases 1 to 4, and also has niche business units in the areas of clinical analytics, medical devices and pharmaceutics. The company said that many of its customers, especially those in Asia, need manufacturing assistance in the US market and that the company’s partnership with Gallus would ensure that these


customers receive the service required for them to advance their trials and prepare for


submission success. Gallus is a CMO operating a commercially licensed


manufacturing site in


St. Louis, Missouri, USA and was established in 2010. It acquired its commercial biopharmaceutical manufacturing facility and workforce from Johnson & Johnson/Centocor division in 2011. The company has more than


support to advance the development of novel therapeutics for cancers associated with Epstein-Barr virus (EBV) and other diseases. Funding will be supported by a Drug Discovery Award from the Wellcome Trust Institute.


DavosPharma has been a provider of services to the pharmaceutical industry ranging from preclinical development to


“AMRI scientists will


collaborate with Knopp scientists and project


leaders on selected novel drug discovery programmes and the collaboration is extendable by mutual agreement”


commercialisation since its foundation in 1972. The company’s ‘Global Discovery Platform’ and its portfolio of partners supports the provision of fully integrated drug discovery, IND-enabling toxicology, formulation, development, and manufacturing specifically tailored to the needs of customers’ programmes. The company is headquartered in Upper Saddle River, New Jersey, USA and has US offices in Research Triangle Park, North Carolina; Pennsylvania Biotechnology Center, Doylestown, Pennsylvania; San Francisco,


California; and San Diego, California, USA. It also has an office in Milan, Italy. The Wistar Institute


is an international leader in biomedical research with expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the USA, the Institute


holds the Cancer Center designation from the US National Cancer Institute.


AMRI and Knopp Biosciences broaden strategic agreement


AMRI has entered into a new strategic agreement with Knopp Biosciences LLC, a drug discovery and development company focused on breakthrough treatments for unmet needs in neurological disorders. Under the two-year term of this FTE agreement, AMRI will provide various discovery-related services including medicinal chemistry, DMPK and computer-aided drug discovery (CADD). As part of the scope of work, AMRI scientists will collaborate with Knopp scientists and project leaders on selected novel drug discovery programmes. The collaboration is extendable after two years by mutual agreement. The agreement builds on the strategic business relationship that already exists between the two companies. Since 2006, AMRI has worked with Knopp to provide early process development work, route development, and small-scale and large-scale cGMP manufacturing, as well as analytical method development and validation support.


Knopp Biosciences is based in Pittsburgh,


Pennsylvania, USA and is focused on delivering breakthrough treatments for unmet needs in neurology. The company’s lead product candidate is dexpramipexole, an orally bioavailable small molecule in Phase 3 development for the treatment of ALS. Biogen Idec holds an exclusive worldwide licence from Knopp to develop and commercialise dexpramipexole, with Knopp providing development support and conducting certain US commercialisation activities. Knopp’s discovery platform is directed to identifying next generation mitochondrial bioenergetic modulators for the treatment of ALS, Parkinson’s disease, and other neurodegenerative disorders, as well as ion channel modulators for the treatment of epilepsy.


Further information For further information on the companies and organisations featured in this article visit the following websites:


www.cambrex.com www.onyxipca.com www.reachseparations.com www.cevec.com www.paragonbioservices.com www.theoremclinical.com www.gallusbiopharma.com www.davos.com www.wistar.org www.amriglobal.com ww.knoppneurosciences.com


September/October 2012 sp2 Inter-Active 27


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