August 11, 2016
Sponsored by Cellonic
Celonic’s CHOvolution™ kit comes with a wide range of exceptional services and solutions, on top of high-performance cells. In addition to robust and highly efficient technology, we offer excellent technical support, including comprehensive protocols, audits, tailored workshops, and a 24-7 information access Internet-based platform with a hotline.
For any drug developer or service provider, cell line development is one of the most challenging phases, especially when subsequent GMP compliance is required. To boost and support successful commercial introduction of biological drugs to the market, Celonic has developed CHOvolution™, a cell line kit that can be used for a broad range of applications ranging from non-GMP R&D testing to GMP development and commercial market supply, with a support system to help throughout every step of development.
Celonic: Beyond Manufacturing
Celonic AG is privately owned CDMO based in Basel, Switzerland providing comprehensive GMP development and manufacturing services for new biological entities (NBEs) and biosimilars worldwide. Applying empathy, efficiency, and excellence, Celonic goes one step beyond expectations in all business aspects to help its clients attain their goals better, more efficiently, and reliably.
Unparalleled expertise and deep insights — honed over almost two decades of extensive experience in the development of expression vectors, cell lines, and media — have enabled Celonic to establish advanced techno-commercial tools and from these, its own proprietary SEFEX (SErum Free EXpression) technology. Celonic now offers its own CHO-K1 host cell line, vectors, and development protocols in the path-breaking CHOvolution™ kit, developed using this innovative technology.
Unlike other GMP CHO cell line kits, CHOvolution™ enables convenient, reliable, easy, and safe regulatory compliant development with high titers (up to 7 g/L). The stable and robust cell line is adapted for suspension culture and growth in chemically defined and commercially available media.
Moreover, CHOvolution™ is royalty-free for partners and customers wishing to use their production cell lines for clinical purposes or market supply. Pragmatic and simplified commercial models enable business partners to use, sublicense, sell, or transfer their developed production cell line later down the development road.
CHOvolution™ Takes You Further
CHOvolution™’s advantages lie in its unique business model and its superior support in helping to integrate a new cell line. The support Celonic offers includes
Quality management system audits available; based on that, guaranteed upgrade of a generated production cell line to a GMP-compliant master cell bank
Risk-mitigation methodologies, shaped on pillars of greater transparency and communication
Comprehensive protocols describing Celonic’s optimized screening and selection processes to establish production cell lines for monoclonal antibody products
Tailored workshops and hands-on training to develop the product
Extended support alongside GMP development and GMP manufacturing
Help with filling for investigational new drug (IND) applications
Technical and scientific support from the CHOvolution™ internet platform; customers can connect with the worldwide CHOvolution™ user community in a dedicated forum moderated by Celonics’ cell line specialists
A telephone hotline for expedited additional support.
Celonic’s business model features
Partnership allows “co-marketing” via Celonic’s homepage
Attractive new business offer to extend service portfolio and attract new customers and increase revenue, especially for non-GMP-service providers
Competitor advantage by expedited Time-to-market
Substantial cost saving due to detailed user guide/protocols for the handling, selection, and screening process of drugs and training/workshop offering
A compliance guarantee based on a quality management system audit to turn the established RCB into an MCB at Celonic
Derisking technology implementation and usage due to training/workshops offering excellent support (partnerships).
Like many of our global successful clients please take advantage of this unique opportunity.
Stavros Theocharidis is sales manager at Celonic, Eulerstrasse 55, 4051 Basel, Switzerland; 00-41-61-56-49-150, [email protected]; www.celonic.com.
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