We deliver end-to-end enzyme development as part of our integrated Pharmaceutical Development & Manufacturing platform, with deep alignment to Drug Substance Development and specialized expertise in Therapeutic Protein Development. From sequence to stable drug-substance, we transform enzyme concepts into robust, manufacturable assets ready for downstream lifecycle advancement.
Overview of Enzyme Development
Enzymes are catalytically active therapeutic proteins requiring precise control of sequence, structure, and microenvironment to achieve the desired biochemical outcome. Effective development unites rational engineering with process science to balance catalytic efficiency, selectivity, stability, and safety-relevant attributes. We deploy quality-by-design principles to map critical quality attributes (CQAs)—such as glycosylation, charge, aggregation, and post-translational modifications—against critical process parameters that govern expression, folding, and purification. Purpose-built analytical methods quantify activity and kinetics under intended-use conditions, while formulation and device compatibility protect function from manufacture through administration.
Our Services
Our enzyme development offering spans sequence design, expression platforming, upstream and downstream process development, analytical and potency method establishment. Services are modular yet integrated, enabling efficient risk reduction across pharmaceutical development & manufacturing, drug substance development, and therapeutic protein development.
Enzyme Candidate Engineering Service
We design and optimize enzyme candidates for manufacturability and function using structure-guided mutagenesis and liability de-risking. Algorithms flag hotspots for oxidation, deamidation, isomerization, and proteolysis; libraries target thermostability, catalytic turnover, and substrate preference. For human-use enzymes, we consider glycan patterns, charge distribution, and potential T-cell epitope content to support a balanced CQA profile. Ranked variants advance to small-scale expression and orthogonal biophysical screening to confirm developability.
Expression System Development Service
We establish host platforms (CHO, HEK, yeast, or E. coli with periplasmic or refolding strategies) chosen by glycosylation needs, secretion efficiency, and scalability. Vector design includes promoter selection, secretion signals, and codon optimization. Stable pools and clones are generated with targeted integration or transposon systems. High-throughput micro-bioreactors enable rapid titer/quality mapping to select cell lines and media feeds that preserve catalytic function and minimize off-target proteolysis.
Upstream Process Development Service
We tailor fed-batch and perfusion processes to match the enzyme's specific folding pathway and cofactor dependencies. We employ Design-of-Experiment (DoE) matrices to systematically explore critical parameters—such as pH, osmolality, dissolved oxygen, redox couples, and trace elements—that influence active-site integrity and expression yield. Real-time PAT readouts (e.g., capacitance, off-gas analytics) correlate culture physiology directly with enzyme activity and aggregation risk. Finally, validated scale-down models precisely emulate mass-transfer and shear profiles, ensuring that upstream settings reliably translate to pilot-ready and manufacturing conditions.
Purification & Refolding Development Service
We craft orthogonal capture and polish schemes that protect activity while meeting purity targets. Depending on the enzyme class, we combine affinity (Protein A alternatives for non-Ig proteins), ion exchange, hydrophobic interaction, mixed-mode, and size exclusion to separate isoforms and remove host-cell proteins, DNA, and process impurities. For inclusion-body routes, we develop refolding cocktails and gradients that reconstitute native conformation and metal-cofactor binding without over-oxidation or disulfide scrambling.
Analytical Characterization Service
Enzyme activity is quantified using mechanism-appropriate assays (chromogenic, fluorogenic, HPLC/UPLC substrate depletion, and LC–MS product formation), with kinetic parameters rigorously established under defined conditions. We also construct comprehensive identity and purity packages utilizing advanced techniques, including intact and reduced MS, peptide mapping, glycan profiling, icIEF/CE-SDS, SEC-MALS, DSC, and DLS. For manufacturing comparability, we implement tiered analytics designed to detect subtle changes that could impact catalytic function.
Glycoengineering & Post-Translational Modulation Service
For mammalian enzymes, we tune glycosylation to balance stability, circulation behavior, and receptor interactions. Media supplements, culture conditions, and targeted host engineering shape fucosylation, sialylation, and branching. Where relevant, we evaluate pegylation, albumin-binding motifs, or Fc-fusion constructs as development-stage options, assessing how modifications influence activity, diffusion, and immunoreactivity while maintaining manufacturability.
Our Enzyme Development Portfolio
Below is a non-exhaustive portfolio of therapeutic enzymes we routinely develop. And, we can extend to adjacent categories upon request, provided they align with therapeutic enzyme use and drug-substance development requirements.
- Asparaginases (amidase hydrolases)
- Pancreatic enzyme replacements (lipase, amylase, protease)
- Superoxide dismutase and catalase (oxidoreductases)
- Collagenases and other matrix proteases
- Serine protease activators (e.g., plasminogen activator class)
- Coagulation-pathway proteases (e.g., thrombin-family enzymes)
- Phenylalanine-metabolizing enzymes (lyase class)
- Hyaluronidases (glycosidases)
- DNase I (endonuclease)
- β-Glucosidase (glucocerebrosidase)
- α-Galactosidase
- Iduronidase
- Deaminases
- Uricases (urate oxidase)
We deliver enzyme development with precision and excellence, with engineering, process, and analytics integrated into a single CDMO pathway. Our services de-risk catalysis and stabilize function. Engage our team to accelerate your enzyme toward reliable, scalable production readiness.
Our products and services are for research use only.
