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Recombinant enzymes are vital components in modern therapeutics, diagnostics, and industrial biotech. From rare disease enzyme replacement therapies (ERTs) to enzymes used in vaccine production, these biologics require highly specialized development and manufacturing processes. That’s why companies turn to expert recombinant enzymes CDMO companies to ensure efficiency, quality, and regulatory compliance.
Whether you´re developing a novel therapeutic enzyme or scaling a recombinant biocatalyst, partnering with the right enzymes contract manufacturing organization can reduce time to market and ensure product success at every stage.
When evaluating recombinant enzymes CDMOs, keep these key criteria in mind:
Expression system flexibility: Can the CDMO work with microbial, yeast, or mammalian platforms?
Process development experience: Proven ability to optimize yields while maintaining bioactivity and stability.
Purification strategies: Expertise in isolating high-purity enzymes, including those prone to degradation.
Analytical capabilities: Robust testing for potency, structure, and contaminant clearance.
Scalability: Facilities that support seamless transition from R&D to GMP commercial production.
Regulatory track record: Familiarity with ERT, diagnostic, or food enzyme regulatory pathways (FDA, EMA, etc.)
Specialized enzyme CDMOs not only understand biologics — they understand enzymes specifically, from folding to function.
Top-tier enzymes contract manufacturing organizations offer a wide array of services tailored to the needs of recombinant enzymes:
Strain and cell line development optimized for target enzyme expression
Upstream development using microbial (E. coli, Pichia pastoris) or mammalian systems
Downstream purification with techniques like affinity, ion-exchange, and hydrophobic interaction chromatography
Enzyme stabilization and formulation for injectable or lyophilized formats
Comprehensive analytical testing: activity assays, purity, structure confirmation, endotoxin testing
GMP manufacturing for clinical and commercial use
CMC documentation and global regulatory support
Whether for medical, diagnostic, or industrial use, these services ensure consistent, compliant enzyme production.
Working with specialized recombinant enzymes CDMO companies brings unique advantages:
Therapeutic focus: Deep experience with enzymes as APIs in rare disease treatments or biologic support roles
Optimized productivity: Proven approaches to maximize enzyme yield and minimize degradation
Custom process design for enzyme-specific folding, cofactor requirements, and stabilization
Regulatory strength from IND through commercial filings
Speed to market via integrated development and manufacturing platforms
These benefits are especially critical for companies working on high-complexity or low-volume enzyme programs.
Some of the most recognized recombinant enzymes CDMO companies include:
53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
Mabion: Fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and any recombinant protein-based products. [See CDMO profile]
Shilpa Biologicals: CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging. [See CDMO profile]
HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
Cambrex: Strong expertise in enzyme screening and developed more than 800 proprietary enzymes of different classes. [See CDMO profile]
Biologics CDMO Companies | Biopharmaceutical Contract Manufacturing
Recombinant Proteins CDMO Companies | Proteins Contract Manufacturing
At MAI CDMO, we specialize in identifying the best recombinant enzymes CDMO companies to support your product goals. Whether you’re scaling an enzyme replacement therapy or producing an enzyme for bioprocessing, we connect you with trusted enzymes contract manufacturing partners with the right technology, capacity, and regulatory expertise.
Need a manufacturing partner you can trust? Contact us today and let us match you with the ideal enzyme CDMO.
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