Catalog Products » Recombinant Proteins » GMP Proteins

Overview

Recombinant proteins including cytokines, growth factors, tag-cleavage enzymes, and CRISPR proteins are necessary ancillary materials utilized during manufacturing in areas such as cell-engineered products, gene-engineered products, regenerative medicine, and fusion protein drug production. While they don’t exist in the final product, the quality of these recombinant proteins may affect its stability, safety, potency, and purity.

GenScript now provides a new GMP (Good Manufacturing Practice) platform to convert GenScript’s RUO (Research Use Only)-grade catalog proteins to GMP-grade. Our GMP-grade recombinant protein products are produced with strict quality management and pharmaceutical-grade release testing standards. They are suitable for use in preclinical and clinical stages. Our goal is to assist your projects, enabling a smooth transition from RUO to GMP.

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Highlights

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Animal-free Process

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Antibiotic-free Production

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Additional QC Availability

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Pharmacopoeia Standards

Proteins

GMP Regulations

GMP Quality Management

  • Grade C and A cleanroom
  • cGMP compliant environment monitoring
  • Pharmaceutical-grade key raw materials and consumables
  • MES production monitoring
  • Sterile water for injection in entire process
  • IQ, OQ, PQ verified equipment
  • Animal component-free processes (ACFP) under GMP-compliance
  • Qualified and well-trained GMP production personnel
  • Full traceability of production and QC records
  • Comprehensive strain and final product stability studies
  • Additional QC tests: Biological Activity, HCP, HCD, Mycoplasma, Sterility, Endotoxin
  • Strict incoming material inspection

GMP Facility

Cell Seeding

Cell Seeding

Fermentation

Fermentation

Protein Purification

Protein Purification

GMP Workflow

Plasmid
Clone
PCB
preparation
MCB
/WCB
Process
development
Scale up
Process
validation
Product
stability

* GMP-grade protein products can use the same cloning, sequence and expression system as non-GMP-grade proteins, and have the same performance, enabling your key materials to achieve seamless conversion to GMP-grade.

Q&A

Q: How long is the development time for a GMP-grade protein?
A: The development time depends on the customer's requirements. Generally, the development time of a GMP-grade protein is 3-6 months.

Q: Can GenScript's GMP-grade protein be directly used in clinical or human injection?
A: GenScript's GMP-grade proteins can be used as key raw materials in the production of your final product, but they cannot be directly used in clinical practice or human injection.

Q: For GMP-grade proteins, what documentation support can GenScript provide?
A: GenScript can provide COA, Datasheet, TSE/BSE statements for free. For other documents such as DMF, etc., please contact us for details.

Q: Can GenScript accept customer audits?
A: Yes, GenScript can accept any online or offline customer audit.

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