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| home > white papers > Delivering Fit For Purpose Biomanufacturing CHO Cell Lines - Fujifilm Diosynth Biotechnologies |
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 WHITE PAPERS |
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Fujifilm Diosynth Biotechnologies
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Delivering Fit For Purpose Biomanufacturing CHO Cell Lines
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The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
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News and Press Releases |
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Treadwell Therapeutics Engages Genezen to Advance its T Cell Receptor-Based Cell Therapy Pipeline
Treadwell Therapeutics, a clinical stage, multi-modality
biotechnology company developing novel therapeutics for highly
aggressive cancers, and Genezen, a cell and gene therapy Contract
Development and Manufacturing Organisation (CDMO) have confirmed a
partnership agreement to accelerate the production of T cell receptor
(TCR)-based candidates to address unmet needs in cancer patients.
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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