Recombinant proteins are produced by genetically engineered expression systems to obtain desired target proteins. Compared to proteins isolated from natural sources, recombinant proteins offer high activity, high purity, batch-to-batch consistency, stringent quality control, and the ability to optimize characteristics such as solubility, stability, and formulation. Types of recombinant proteins include biopharmaceuticals, industrial enzymes, diagnostic proteins, vaccines, food additives, aesthetic proteins, peptides, biosensors, and biocatalysts.

Applications of Recombinant Proteins

Recombinant Protein Expression Systems

Recombinant protein expression systems are typically divided into prokaryotic expression, eukaryotic expression, insect cell expression, and mammalian cell expression.

Introduction to CMO Service Platform

HZYMES specializes in developing biological raw materials and comprehensive technical solutions. With extensive experience in custom development and large-scale production of recombinant proteins, it offers GMP-grade production services. The platform includes flexible fermentation platforms ranging from 5L to 100T, chromatography systems of various capacities, and freeze-drying platforms from 0.2㎡ to 20㎡.

With a complete quality management system, strict control over production processes, and rigorous release standards for intermediates and final products, HZYMES ensures batch-to-batch consistency to meet production needs across research, pilot, and industrial scales.

Fermentation Process

Fermentation begins with small-scale shaking flask cultivation to determine optimal microbial growth conditions before scaling up in fermentation tanks. During high-density fermentation, cultivation methods and conditions are improved (e.g., batch fermentation, fed-batch, or continuous fermentation) to significantly enhance fermentation density while balancing cost and efficiency. Key parameters include pH, temperature, dissolved oxygen, carbon dioxide levels, aeration, agitation, and resulting shear forces.

Fermentation Equipment Scaling:

• Shaking flasks for strain recovery.
• 5L fermenters for preliminary parameter testing.
• 50L fermenters for industrial pre-scale verification.

Example: 

Using 500L fermenters, HZYMES achieves high-density fermentation for specific projects (E. coli and yeast expression systems).

Services:

HZYMES provides process development and scale-up production using various fermentation platforms, optimizing key parameters for stable fermentation processes.

Purification Process

Affinity Chromatography (AC):

Commonly used for purifying His-tagged proteins, this method achieves over 85% purity in a single step and is widely applied in antigens and diagnostic enzymes.

Size Exclusion Chromatography (SEC):

Separates molecules by size, with large molecules eluting first and small molecules eluting later. Simple operation but limited sample capacity and higher costs due to equipment requirements.

Ion Exchange Chromatography (IEX):

Separates molecules based on reversible charge interactions. Adjusting buffer pH or ionic strength controls binding and elution, widely used for proteins and nucleic acids.

Hydrophobic Interaction Chromatography (HIC):

Utilizes hydrophobic differences between proteins for separation. Gradual reduction in salt concentration sequentially releases proteins based on their hydrophobicity.

Services:

HZYMES provides purification platforms of various scales, enabling quick process transfer and scale-up to produce high-activity proteins meeting quality standards.

Case Study:

• Project C (E. coli): Developed a special purification protocol achieving 99.9% purity, endotoxin levels <10 EU/mg, expression levels of 20 mg/g wet biomass, with batch yields exceeding hundreds of grams.

Freeze-Drying Process

Recombinant protein liquid formulations are prone to instability, aggregation, or denaturation during storage and transportation under low-temperature conditions. Freeze-drying improves stability while reducing storage and transportation costs.

Services:

HZYMES offers freeze-drying platforms of various scales and advanced formulation development techniques, with automated systems ensuring aseptic production.

CMO Service Workflow

1.Custom Service Workflow

Tailored solutions for unique customer needs.

2.Standard Service Workflow

Efficient processes for common requirements.

Service Highlights

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