What We Do

Microbial Systems. Immune Innovation. Beyond the Cell.

Mika Biologics is a contract development and manufacturing organization (CDMO) with a singular focus: microbial platforms. We exist for innovators who need a partner that not only understands E. coli, yeast, and fungi, but elevates them into cutting-edge biologics manufacturing systems.

Unlike mainstream CDMOs that dilute attention across mammalian and microbial platforms, Mika Biologics builds its identity around precision microbial engineering. We believe that microbial hosts are not merely low-cost alternatives, but are foundational engines of the biologics future.

Our services span the full development lifecycle—from early research expression systems to GMP-grade supply. We position ourselves as both specialists and scalers: specialists in nine carefully chosen niches, and scalers who can take projects from concept to global supply with reproducibility and quality.

Our Portfolio of Services

Cell-Free Biologics (TX–TL Systems)

Overview

Cell-free transcription–translation (TX–TL) systems are revolutionizing protein production. By leveraging ribosomes, polymerases, and cofactors extracted from microbial cells, biologics can be synthesized in open, cell-free environments without the constraints of living organisms. This enables rapid prototyping, high-throughput screening, and scalable on-demand production.

What We Offer

• Custom E. coli Extracts: Tailored TX–TL systems optimized for client-specific proteins, with variable energy regeneration systems and tunable cofactors.
• Vaccine Prototyping: Rapid antigen synthesis within days, supporting outbreak response or early immunogen discovery.
• Enzyme Discovery Platforms: Parallel synthesis of enzyme variants for industrial or therapeutic applications.
• Scale-Up to GMP: Transitioning lab-scale TX–TL into controlled manufacturing with rigorous QC.

Why Mika

Most CDMOs lack dedicated cell-free expertise. At Mika, we treat TX–TL as a core business line, not a side project. Our microbial fermentation expertise underpins our ability to create consistent, high-yield ribosome extracts, making us one of the few CDMOs that can deliver cell-free systems as a service.

Immune Biologics (Cytokines & Immunomodulators)

Overview

Cytokines and immune modulators are the backbone of modern immunotherapy, enabling cell therapy expansion, tumor microenvironment modulation, and systemic immune regulation. Many cytokines—including IL-2, IL-7, and GM-CSF—are well-suited to microbial expression, though they require careful folding and activity validation.

What We Offer

• Cytokine Expression Libraries: IL-2, IL-7, IL-15, GM-CSF, interferons, and checkpoint ligands.
• Folding & Solubility Expertise: Proprietary refolding workflows that recover active cytokines from inclusion bodies.
• Bioactivity Validation: Cell-based assays to confirm receptor binding and downstream pathway activation.
• Scale-Ready Manufacturing: From R&D batches to GMP supply for clinical trials.

Why Mika

Mainstream CDMOs often avoid cytokines due to solubility and refolding challenges. At Mika, these are not obstacles—they are our specialty workflows. By combining fermentation, refolding, and bioassay expertise, we help clients de-risk cytokine programs and move toward clinical impact.

Fungal & Yeast Expression Systems

Overview

Yeasts (Pichia pastoris, Saccharomyces cerevisiae) and filamentous fungi (Aspergillus, Trichoderma) offer secretion efficiency, post-translational modifications, and scalability unmatched by mammalian cells for certain biologics. Fungi are particularly powerful for glycosylated enzymes, secondary metabolites, and sustainable alternatives to mammalian expression.

What We Offer

• Pichia Glycoengineering: Customized glycosylation pathways for biologics requiring human-like glycans.
• Aspergillus/Trichoderma Enzyme Production: High-yield fermentation for carbohydrases, proteases, and industrial enzymes.
• Secreted Protein Workflows: Simplified downstream processing via extracellular secretion.
• Multi-Step Pathways: Engineering co-cultures or fungal consortia for complex biosynthetic products.

Why Mika

Most CDMOs underutilize fungi, viewing them as niche. At Mika, fungi and yeast are core to our microbial identity, enabling us to serve industries from therapeutics to next-gen food proteins.

Rare Biologics & Orphan-Scale GMP

Overview

Rare diseases and orphan drugs often require small-batch biologics, where mainstream CDMOs see low volume and low priority. Mika Biologics sees high value and human impact.

What We Offer

• Small-Batch GMP: Flexible runs for <50 L through pilot fermentors.
• Customized Timelines: Agile project planning tailored to rare disease innovators.
• Rare Enzyme Manufacturing: Lysosomal enzymes, orphan cytokines, or diagnostic proteins.
• Regulatory Alignment: Support for orphan drug designations, regulatory submissions, and accelerated pathways.

Why Mika

We built Mika for projects too small for Catalent, too complex for generic microbial houses. By focusing on rare biologics, we enable therapies for patients who might otherwise be overlooked.

Synthetic Biology Tools & Enzyme Engineering

Overview

Synthetic biology depends on a reliable supply of enzymes, nucleases, and molecular biology toolkits. From CRISPR proteins to polymerases, microbial fermentation is the most efficient way to generate these workhorses.

What We Offer

• CRISPR Proteins & Editors: Cas9, Cas12, Cas13, and novel nucleases.
• Polymerases & Ligases: High-fidelity polymerases, thermostable ligases, and specialty enzymes.
• Custom Enzyme Engineering: Directed evolution, rational design, and fermentation-scale production.
• Diagnostics Supply Chains: Enzymes for qPCR, NGS, and point-of-care tests.

Why Mika

Rather than treating enzymes as “commodities,” we specialize in custom, high-purity enzyme systems tailored for therapeutic or diagnostic applications. Our refolding, activity validation, and scale-up workflows distinguish us from bulk suppliers.

Microbial Vaccines & VLPs (Virus-Like Particles)

Overview

Virus-like particles (VLPs) and microbial vaccines offer safer, scalable immunization platforms. Unlike live viruses, VLPs lack genetic material but preserve the immunogenic surface architecture.

What We Offer

• E. coli & Yeast VLP Expression: Assembly of immunogenic capsids for vaccine candidates.
• Nanomaterials & Scaffolds: Engineered VLPs for drug delivery and biomaterials.
• Microbial Vaccine Development: Fermentation-based vaccines for global health.
• Analytical Characterization: Structural validation, particle size analysis, and immunogenicity assays.

Why Mika

Vaccine developers face supply bottlenecks with mammalian systems. Our microbial-first approach delivers rapid, cost-efficient VLP scaffolds at global scale.

Endotoxin-Free Biologics

Overview

Endotoxins from Gram-negative bacteria are a persistent challenge in microbial biologics manufacturing. Novel strains like ClearColi® eliminate this burden by engineering away endotoxin pathways.

What We Offer

• ClearColi® Fermentation: Endotoxin-free plasmids, proteins, and biologics.
• Downstream Simplification: Reduced endotoxin clearance steps, lowering COGS.
• Regulatory Advantage: De-risked submissions with reduced pyrogenicity risks.
• Custom Strain Development: Engineering microbial hosts for endotoxin-free production.

Why Mika

We are among the first CDMOs to brand an endotoxin-free service line. For clients, this means cleaner biologics, faster QC, and lower costs.

Engineered Probiotic Biologics

Overview

Live biotherapeutic products (LBPs) are reshaping microbiome medicine. Engineered probiotics like E. coli Nissle or Lactobacillus can deliver therapeutic proteins, modulate the gut, or enhance immune responses.

What We Offer

• Strain Development: Engineering LBPs with CRISPR or metabolic rewiring.
• Fermentation & GMP Supply: Scalable probiotic production in controlled environments.
• Therapeutic Payloads: Expression of cytokines, enzymes, or checkpoint proteins within probiotics.
• Regulatory Guidance: Support for FDA/EMA LBP pathways.

Why Mika

Few CDMOs understand LBPs. Mika integrates microbial expertise + regulatory awareness to support the microbiome revolution.

Biologic Nanoparticles

Overview

Self-assembling protein nanoparticles and enzyme scaffolds represent the next wave of biologic materials. Microbial hosts are ideal factories for these assemblies, which can serve as drug carriers, biomaterials, or novel immunogens.

What We Offer

• Protein Nanoparticle Assembly: Scalable microbial production of self-assembling protein structures.
• Biomaterial Development: Enzyme or protein scaffolds for industrial and therapeutic use.
• Drug Delivery Platforms: Nanoparticles tailored for payload conjugation.
• Custom Design & Screening: Rational design, mutagenesis, and microbial validation.

Why Mika

This is a visionary frontier—and Mika positions itself at the edge, building the tools for the next generation of biologic materials.

The Synergy of Our Portfolio

This portfolio is not accidental. Each service builds upon our microbial foundation, creating synergies across expression platforms:

• Cell-free extracts are derived from microbial fermentation.
• Cytokines often require refolding workflows honed in enzyme engineering.
• Fungal/yeast expression complements bacterial systems with glycosylation.
• VLPs and nanoparticles merge immunology with microbial assembly systems.
• Endotoxin-free workflows simplify every downstream process.
• Probiotic biologics bring therapeutic function into live microbial hosts.

Together, these services form a coherent specialist ecosystem—not a catch-all. Mika is the CDMO for companies who believe microbial systems are not an alternative, but the future backbone of biologics.

Conclusion of CDMO Services

Mika Biologics offers nine integrated service verticals:

1. Cell-Free Biologics (TX–TL Systems)
2. Immune Biologics (Cytokines & Immunomodulators)
3. Fungal & Yeast Expression Systems
4. Rare Biologics & Orphan-Scale GMP
5. Synthetic Biology Tools & Enzyme Engineering
6. Microbial Vaccines & VLPs
7. Endotoxin-Free Biologics
8. Engineered Probiotic Biologics
9. Biologic Nanoparticles

Each is built on the microbial cell factory—scaled, validated, and translated into clinical and commercial impact.

Contact our team directly at info@mikabiologics.com