GMP Recombinant Protein Service

GMP (Good Manufacturing Practice) recombinant proteins are a type of recombinant protein that meets GMP requirements throughout the production process, ensuring stringent quality control and safety measures. These proteins are typically produced using cell-based expression systems, such as mammalian cells or yeast, and undergo a series of purification and quality control steps to ensure their safety and efficacy.

Creative BioMart can overcome difficulties and challenges in many aspects of GMP recombinant protein production, including host cell selection and optimization, gene expression regulation, protein purification and identification, and production process monitoring. Using Our services, consumers can obtain high-quality, efficient recombinant proteins following GMP guidelines.

Reasons to Choose GMP Recombinant Proteins

• High Purity

During multiple purification steps, the protein is ensured to be free of impurities and other protein contamination.

• High Activity

A high level of biological activity is preserved during the production process of GMP recombinant proteins, which makes them effective when used preclinically.

• Strong Consistency

The same quality and efficacy can be maintained in multiple batches of production, ensuring the safety and effectiveness of medication.

• Low Endotoxin

The endotoxin content is extremely low, which is due to the strict control of raw materials and production environment during the production process to ensure product safety.

• Traceability

There are comprehensive records and traceability from the raw materials to production processes to the final product, guaranteeing product quality and safety.

• Large-scale Production

The production line is complete and can achieve large-scale production to meet preclinical and market needs.

• Meet GMP Regulatory Requirements

The production fully adheres to domestic and foreign regulations and standards related to pharmaceutical production, ensuring product compliance.

Figure 1. GMP recombinant protein service process.

What Service Items We Offer?

• Optimize the design of gene sequences. Obtain the sequence information of the target gene through biological methods such as gene synthesis or PCR.
• Construct recombinant plasmids. Insert the target gene into the expression vector to construct a recombinant plasmid.
• Transform host cells. Transform the recombinant plasmid into host cells. Commonly used host cells include bacteria (such as Escherichia coli), fungi (such as Pichia pastoris, Saccharomyces cerevisiae), and cells (mammalian cells).
• Screen positive clones. Through specific screening methods, positive clones containing the target gene are screened from numerous transformants.
• Recombinant strain culture. The positive clones were cultured in shake flasks, and the recombinant protein was initially expressed and purified.
• Recombinant protein expression. Induce the expression of the target protein by adding inducers and other methods.
• Recombinant protein purification. Recombinant proteins are highly purified using various purification techniques, such as affinity chromatography, ion exchange chromatography, gel filtration, etc.
• SDS-PAGE / Western Blot. The purified recombinant protein is identified through SDS-PAGE, Western Blot, and other methods to confirm its properties and activity.
• Industrial production. Industrial production and quality control are achieved through small-scale process development, pilot scale-up, GMP production, and other steps.

Outstanding Advantages of Our Service

• One-stop platform. Advanced technology and rich experience can meet the different customization needs of customers.
• Comply with regulations and standards. The production of GMP recombinant proteins complies with relevant regulations and standards to ensure product safety and compliance.
• Fast delivery, saving customers time and money.

As an industry-leading manufacturer of GMP proteins, Creative BioMart provides customers with a variety of choices and customized services, aiming to provide a solid research foundation for the field of life sciences. If you are interested in our services, please contact us as soon as possible.