CDMO SERVICES
Cell Line Development

Cell Line Development

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.
 

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.
 

Mycenax’s Cell Line Development Services:

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.

 

  
 

             
 
 

Product Types:

◆ Monoclonal antibodies

  

◆ Peptides

  

◆ Enzymes

◆ Bi-specific antibodies

   ◆ Protein conjugates (non-toxin)  

◆ Antigen-binding fragments (Fab)

◆ Fc-fusion proteins

   ◆ Transgenic proteins  

◆ Single-chain variable fragments (ScFv)

◆ Recombinant proteins

   ◆ Antibody-cell conjugates    
 
 
 
 

Mycenax develops high-performance microbial cell lines for the expression of recombinant proteins. We use a rapid cell line development system to facilitate process development and scale-up by applying techniques as follow:

◆

Use of IPTG inducible gene promoters

◆

Use of removable leader sequences for localizing proteins, increasing expression and solubility

◆

Availability of in-house GMP-grade enzyme to remove leader sequences 

◆

Optimization of characteristics of the specific host cells to increase the correctness of protein folding and disulfide bond formation

 
 

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.
 

Product Types:

◆   Recombinant protein

  

◆   Antigen-binding fragment (Fab)

◆   Peptide

  

◆   Single-chain variable fragment (ScFv)

◆   Plasmid

  

◆   Enzyme

◆   DNA vaccine

    
 

Guidance for Cell Line Development Sercives:

I.   ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

II.  ICH Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

III. ICH Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

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.

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.
 

Mycenax’s Cell Line 
Development Services:
 

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.
 
 
 

 

 

 
 
 
 

Product Types:

◆ Monoclonal antibodies

◆ Bi-specific antibodies

◆ Fc-fusion proteins

◆ Recombinant proteins

◆ Peptides

◆ Protein conjugates (non-toxin)

◆ Transgenic proteins

◆ Antibody-cell conjugates

◆ Enzymes

◆ Antigen-binding fragments (Fab)

◆ Single-chain variable fragments (ScFv)
 
 
 

Mycenax develops high-performance microbial cell lines for the expression of recombinant proteins. We use a rapid cell line development system to facilitate process development and scale-up by applying techniques as follow:

◆

Use of IPTG inducible gene promoters

◆

Use of removable leader sequences for localizing proteins, increasing expression and solubility

◆

Availability of in-house GMP-grade enzyme to remove leader sequences

◆

Optimization of characteristics of the specific host cells to increase the correctness of protein folding and disulfide bond formation

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.
 

Product Types:

◆ Recombinant protein

◆ Peptide

◆ Plasmid

◆ DNA vaccine

◆ Antigen-binding fragment (Fab)

◆ Single-chain variable fragment (ScFv)

◆ Enzyme
 

Guidance for Cell Line Development Sercives:

I.   ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

II.  ICH Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

III. ICH Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

Case Study: Developing the Next-Gen Cell Line Development Platform with [Bruker Cellular Analysis]
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