Providing a Comprehensive Range of Biopharmaceutical Process Development and cGMP Manufacturing Services - - BioPharm International

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Providing a Comprehensive Range of Biopharmaceutical Process Development and cGMP Manufacturing Services


BioPharm International

Cytovance Biologics is a contract biopharmaceutical process development and cGMP manufacturing organization specializing in products derived from mammalian cell culture. Our highly experienced team of experts is committed to providing best-in-class services that help our customers move recombinant protein and antibody products rapidly and cost-effectively into and through clinical development. We employ a collaborative and flexible approach and business practices that meet the long-term needs of our customers and deliver long-term value and support.

Services



Cytovance Biologics offers a comprehensive range of process development services that deliver robust, scaleable, and compliant processes to be transferred into the cGMP production environments. These include process troubleshooting, cell line selection, cell culture development and optimization, purification development, and analytical development and qualification. The process development group is also expert in technology transfer both into and out of our operations. Our cGMP cell banking practice delivers master and working cell banks prepared in accordance with ICH guidelines.

Facilities

Cytovance Biologics operates from state-of-the-art facilities located at the Presbyterian Health Foundation Research Park in Oklahoma City, OK. Our 44,000 sq. ft. custom-designed multi-product cGMP production facility features bioreactor suites at 100 L and 500 L scale with associated purification and support infrastructure. Batch, fed batch, and perfusion processes can be accommodated and significant expansion space is available to accommodate project growth. This new world-class facility meets the latest international regulatory standards and was designed to support commercial production.



A second adjacent cGMP facility houses our cell banking practice and an additional four large cGMP processing cleanrooms that are available for custom projects or dedicated production. Well-equipped process development laboratories and Cytovance's administrative offices are located in a third building at the same location.

People and Philosophy

At Cytovance Biologics we measure our success by the success of our customers. It is our objective to develop open, collaborative long-term relationships with every customer and to be viewed as a trusted and reliable partner. Our team has been involved in the development and production of numerous products that are now marketed throughout the world and intimately understands both the technical and business challenges that are faced when developing biopharmaceuticals. We bring this strong client-side experience to bear in the design and execution of customer projects that deliver on-time and on-budget performance and create long-term value. All operations are supported by carefully designed quality laboratories, systems and procedures, and highly experienced quality assurance and quality control staff. We are happy to assist with the development of appropriate regulatory submissions and to attend meetings with international regulatory authorities. To learn more about "the Cytovance Difference" please contact



Company info
Cytovance Biologics LLC
840 Research Parkway, Suite 400
Oklahoma City, OK 73104
Tel: 405.319.8310
Fax: 405.319.8369
Email:

Website: http://www.cytovance.com/

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