Mycenax offers end-to-end support for microbial-expressed products, guiding clients from early-stage process development to successful commercialization. Our expertise addresses critical challenges in solubility, yield, quality, and stability while enhancing manufacturability and process efficiency at every stage. Whether your project necessitates full process development, optimization of the current process, or outsourced manufacturing services, we tailor our approach to meet your specific requirements.

Product Types We Work With: 

Plasmid

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Enzyme

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Cytokine

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Antibody fragment

Enhance Microbial Process Performance

We provide comprehensive support encompassing cell line development through upstream and downstream process development for various product types, including recombinant proteins and plasmid DNA. With our deep expertise in:

High-yield cell line development for enhanced productivity with robust, high-expression cell lines.

High-cell-density process development accelerates timelines, reduces costs, and enhances scalability.

High-throughput resin screening supports fast-track process development, resulting in shorter timelines to clinic and market.

End-to-end microbial process development from preclinical trials through commercial production

Leveraging extensive experience in microbial production of recombinant proteins and plasmids, Mycenax offers a one-stop CDMO solution. 

We specialize in process development, tech transfer, and optimization, supporting products from preclinical stages through to commercial launch.

Cell Line Development and Cell Banking

Reliable preparation of the production strain is crucial for product integrity and consistency in commercial production. Establishing a stable, well-characterized, and high-yield microbial cell line is a key element for the manufacturing of microbial-based biopharmaceuticals.

Our team of experienced scientists leverages a rigorous, data-driven approach to identify and select the optimal cell line for production.

Our microbial cell line development and cell banking capabilities include:

Strain screening for high productivity

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Expression condition screening for enhancing protein solubility and expression level

Cytoplasmic (soluble/insoluble) and periplasmic expression

RCB establishment

cGMP cell banking and storage

 Upstream Process Development 

Mycenax has experiences in developing upstream processes using E. coli, successfully producing plasmid DNA and recombinant proteins including therapeutic proteins, enzymes, cytokines, and antibody fragments through various expression strategies.

We specialize in designing approaches to optimize or develop high-cell-density, high-yielding, robust, and scalable fermentation processes. We ensure efficient process development, improving productivity and cost-effectiveness.

Our upstream process development capabilities include:

High-cell-density process development

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Feeding Strategy development

Process scale-up

Scalable clarification process development

Downstream Process Development

Leveraging years of experience, we define a modular workflow for DSP unit operations. By combining your knowledge of the target molecule with our biopharmaceutical manufacturing expertise and high-throughput approach, we ensure efficient development without compromising on product quality. With integrated fermentation, purification, and analytical teams, MBI delivers flexible, high-quality solutions for every project.

Our downstream purification capabilities include:

High-throughput resin screening with parallel chromatography

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Column and membrane chromatography development and optimization

Impurity removal studies

Scalable refolding process development

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Tangential flow filtration development

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Process scale-up