Cell Line Development
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For a better microbial cell line development service, Mycenax has signed a cooperation agreement with Vectron Biosolutions, a Norwegian company with leading microbial expression system optimization technology. Under the terms of the agreement, Vectron and Mycenax will join forces to offer the industry a superior and complete solution for the industrial microbial production of therapeutic proteins. Vectron will use its proprietary VB Expression technology platform to develop robust and cost-efficient microbial strains for production of therapeutic proteins. The microbial strains will be transferred to Mycenax’s state-of-the-art biopharmaceutical manufacturing facility to produce pre-clinical and clinical materials. The combined services of Mycenax and Vectron fulfill the needs of CDMO customers who require protein production with large scale, low cost, and high quality. |
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Guidance for Cell Line Development Sercives: |
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I. ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin |
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II. ICH Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
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III. ICH Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products |
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Case Study: Developing the Next-Gen Cell Line Development Platform with [Bruker Cellular Analysis] |
Mycenax develops and establishes high-quality cell lines for various host cell and product types. We are the experts for all cell line development activities, from vector construction to generating cell banks for GMP manufacturing following ICH and global regulatory requirements. We also support early-stage material generation for proof-of-concept studies or preclinical development programs. |
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Mycenax carries out cell line development as a stand-alone service or an integrated end-to-end development solution, including process development and GMP manufacturing. This service along with Mycenax’s proprietary cell line development platforms can shorten the development time. |
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Mycenax develops high-quality mammalian cell lines from vector construction to cell bank generation. For different projects with different purposes, we can provide antibody humanization and transient transfection before establishing a stable production cell line. To ensure a high productivity of your cell line right from the beginning, we support the design of your gene of interest by codon optimization and our in-house signal peptide library. |
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Guidance for Cell Line Development Sercives: |
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Case Study: Developing the Next-Gen Cell Line Development Platform with [Bruker Cellular Analysis] |