Customized enzyme development and production

Customized enzyme development is a subfield of biotechnology and bioengineering that focuses on creating and modifying enzymes to carry out particular tasks or catalyze particular reactions with great selectivity and efficiency.

GenScript's cutting-edge, all-inclusive enzyme development platform includes AI-driven enzyme design, high-throughput screening of enzyme candidates, cell banking, cell culture and purification process optimization, formulation development, analytical method development, stability assessment, and scalable production.

Optimizing enzyme activity, stability, and specificity is challenging for customized enzyme production. Utilizing the enzyme development platform, GenScript modifies enzyme performance to satisfy exacting specifications in various applications and procedures. The approach combines sophisticated molecular, cellular, and bioanalytical techniques with cutting-edge machine-learning capabilities.

This all-encompassing strategy directs the high throughput, precise design, thorough screening, and careful analysis of enormous libraries comprising thousands of enzyme variations. Every variation is subjected to thorough sequencing, which makes it easier to determine the connections between its functional performance and genetic sequence.

GenScript provides scalable production utilizing the E. coli expression system and enzyme creation. With more than 50,000 batches of recombinant proteins delivered reliably and at cost-effective rates, GenScript has a wealth of experience and a solid track record.

Highlights

• Verified enzyme activity
• AI-powered enzyme design
• State-of-the-art facility
• High consistency

Service details

Candidates screening (HTP Mini Scale)

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• High-throughput protein expression
  • Expression Volume: 4-50 mL
  • Capacity: 700 samples/week
• Expression level evaluation
  • Assess the degree of protein expression and solubility
• Primary activity test
  • It is possible to measure enzyme activity in crude or low-purity materials

Candidates screening (Small scale)

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• Small-scale protein expression
  • Expression volume: 1 L (Flask) or 5 L (Fermenter)
  • Capacity: 200 samples/week
• Yield and quality evaluation
  • Data on yield and quality following purification
• Activity test
  • Certain contaminants impact the performance of enzyme candidates. Some candidates' performance needs to be verified again on a smaller scale.

Cell banking

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• High expression level stain construction
  • Vector and strain screening, and codon optimization
• Cell banking
  • PCB, MCB, and WCB Construction
• Stability test of cell bank
  • Stability After 10–50 generations of WCB, the plasmid loss rate and expression level will be assessed
• Phage test of WCB
  • Use the Double-Layer Agar (DLA) technique to test the phage in the master and working cell banks
• Long-term viability test of WCB
  • The viability and expression levels of functional cell banks will be examined on a regular basis to determine storage time

Upstream process development

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• Cell culture process development
  • Expression Volume: 20–500 L (Fermenter);
  • Fermentation Process: High density; Cell Density (OD 600) > 200

Downstream process development

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• Purification Process Development
  • His tag or tag-free protein; HPLC purity: up to 99%
  • Endotoxin level: <1 Eu /mg; Yield: Up to 15 g/L)
• Purification Process Validation (> 3 batches)

Analytical methods development

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• Activity: molecular biology enzyme; IVD enzymes; synthesis biology enzymes
• Residual: HCP; HCD; Nuclease; Endotoxin; metal; Mycoplasma
• Purity: SDS-PAGE; SEC-HPLC; RP-HPLC
• Concentration: A280; Bradford

Formulation development

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• Storage buffer selection
  • The performance of buffer candidates will be examined under stress conditions to check purity or activity at some places
• Freeze-thaw test
  • Freeze-thaw test by 10 times
• Lyophilization

Stability assessment

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• Stress test
  • Two stress situations: verify purity or activity four times in a month
• Accelerated test
  • Two accelerated conditions: verify purity or activity three times in six months
• Long-term stability test
  • Under storage conditions, assess purity or activity 9 times per 24 months
• Shipping condition test
  • Shipping condition confirmation

Scale-up production

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• Tracible batch record
• Validated consistency
• 300 L–20,000 L fermenter
• 5 m² lyophilizer
• Follow the developed SOP