Upstream Process Development

Mycenax provides flexible upstream process development solutions from early-stage development to commercial production for mAbs, bsAbs, and recombinant proteins. Our high-performance platforms and quality modulation strategies enhance productivity and optimize product qualities. With proven technology transfer and scale-up expertise, Mycenax enables a smooth transition to GMP manufacturing while maintaining robust processes.

 

 

       
  Proven Track Record   Experienced Team   High Yield  
  Experience in developing over 100 protein therapeutics with robust upstream capabilities.  

With 10+ years of bioprocess expertise, we deliver high-yield, scalable solutions from concept to commercial success.

  Advanced optimization strategies achieving yields up to 9 g/L.  

 

 

Key Highlights

 

 
 
 
 
 

Productivity Improvement Strategies

 

Quality Modulation Toolboxes

 

Process Scale-up Technique

 
 

Tailored process optimization strategies to enhance productivity, adapting to the unique characteristics of different products and cell lines.

 

A comprehensive toolbox for modulating protein glycosylation and charge variants, successfully optimizing these attributes for over 10 biosimilar products.

 

Mycenax offers expert scale-up solutions, minimizing risks and ensuring a seamless technology transfer to a GMP facility while maintaining consistent productivity and product quality.

 

 

 


 

 

Productivity improvement Strategies

 

With 20 years of upstream experience, Mycenax has developed optimized media and feed libraries for mAbs, bsAbs, and recombinant proteins to boost productivity.

For complex proteins, its intensified fed-batch platform and perfusion strategy enhance process VCD by ~6X, enabling faster development and reliable delivery.

 
 

 

 

 

Quality Modulation Toolboxes

 

Mycenax has established modulation toolboxes to refine various glycosylation profiles—such as galactosylation, sialylation, fucosylation, and mannosylation. Leveraging this toolbox, our expertise has successfully developed more than 10 biosimilar products, delivering tailored solutions for our clients.

 
   

(Using our Quality Modulation Toolbox, we precisely adjust the glycan profile to achieve a close match with the RMP)

 

 

Process Scale-up Technique

 

With our extensive expertise in scaling, we can seamlessly transfer technology to GMP facilities, achieving highly comparable yields and product qualities.

 
     

 

 

Utilizing state-of-the-art upstream equipment
 
  • Sartorius Biostat® B
  • Getinge (Applikon) ez-Control system
  • Cytiva ReadyToProcess WAVE system
  • Sartorius Ambr® 15 and Ambr® 250 High Throughput
  • Cytiva Xcellerex XDR-50 system
  • Roche Cedex Bio and NEXCELOM Cellometer AutoT4
   

 

 

 

Mycenax provides flexible upstream process development solutions from early-stage development to commercial production for mAbs, bsAbs, and recombinant proteins. Our high-performance platforms and quality modulation strategies enhance productivity and optimize product qualities. With proven technology transfer and scale-up expertise, Mycenax enables a smooth transition to GMP manufacturing while maintaining robust processes.

 

 

Proven Track Record
Experience in developing over 100 protein therapeutics with robust upstream capabilities.
 
 
Experienced Team
With 10+ years of bioprocess expertise, we deliver high-yield, scalable solutions from concept to commercial success.
     
     
High Yield
Advanced optimization strategies achieving yields up to 9 g/L.

 

 

Key Highlights

 

 

Productivity Improvement Strategies

Tailored process optimization strategies to enhance productivity, adapting to the unique characteristics of different products and cell lines.

 
 
Quality Modulation Toolboxes
A comprehensive toolbox for modulating protein glycosylation and charge variants, successfully optimizing these attributes for over 10 biosimilar products.
 
 
Process Scale-up Technique
Mycenax offers expert scale-up solutions, minimizing risks and ensuring a seamless technology transfer to a GMP facility while maintaining consistent productivity and product quality.

 


 

Productivity improvement Strategies

 

With 20 years of upstream experience, Mycenax has developed optimized media and feed libraries for mAbs, bsAbs, and recombinant proteins to boost productivity.

For complex proteins, its intensified fed-batch platform and perfusion strategy enhance process VCD by ~6X, enabling faster development and reliable delivery.

 
 

 

 

 

Quality Modulation Toolboxes

 

Mycenax has established modulation toolboxes to refine various glycosylation profiles—such as galactosylation, sialylation, fucosylation, and mannosylation. Leveraging this toolbox, our expertise has successfully developed more than 10 biosimilar products, delivering tailored solutions for our clients.

 

(Using our Quality Modulation Toolbox, we precisely adjust the glycan profile to achieve a close match with the RMP)

 

 

 

Process Scale-up Technique

 

With our extensive expertise in scaling, we can seamlessly transfer technology to GMP facilities, achieving highly comparable yields and product qualities.

 

 

 

 

Utilizing state-of-the-art upstream equipment
 
  • Sartorius Biostat® B
  • Getinge (Applikon) ez-Control system
  • Cytiva ReadyToProcess WAVE system
  • Sartorius Ambr® 15 and Ambr® 250 High Throughput
  • Cytiva Xcellerex XDR-50 system
  • Roche Cedex Bio and NEXCELOM Cellometer AutoT4
   

 

 

 

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