GMP Bacterial Protein Expression

Applications

FAQs

• 1. What are GMP-grade enzymes?

  A: GMP-grade enzymes are manufactured according to guidelines that allow their use as ancillary materials in cell therapy development or other manufacturing processes. GMP proteins are accompanied by extensive documentation and traceability, as well as additional quality control testing.

• 2. What is the difference between the RUO and the GMP-grade enzymes?

  A: Frequently, the sequence, expression system, and basic manufacturing standard operating procedures (SOPs) for RUO and GMP-grade enzymes are identical, which makes the transition between the two as seamless as possible. However, the key difference between RUO and GMP-grade enzymes lies in their intended use and the level of regulatory oversight applied to their production and testing. RUO enzymes are intended solely for research purposes. They are not subject to the same regulatory scrutiny as GMP-grade enzymes, which are intended for clinical use and must adhere to strict regulatory standards.

• 3. When should I need GMP-grade enzymes?

  A: It is recommended to use GMP-grade enzymes as early as possible in the development process to minimize the risk of contamination and ensure that the final product meets regulatory requirements for clinical use.

• 4. Can GenScript's GMP-grade protein be used directly in clinical settings or for human injection?

  A: GenScript's GMP-grade proteins can only serve as vital raw materials in the production of your final product and cannot be used directly in clinical practice or for human injection.

• 5. What documentation support does GenScript provide for GMP-grade proteins?

  A: GenScript provides COA, datasheet, and TSE/BSE statements at no cost. Please contact us for more details on other documents, such as DMF.

• 6. Do you run cell-based assays to test GMP protein performance?

  A: Yes, GenScript provides cell-based assays for enzyme in-vivo & in-vitro activity.

• 7. Do you provide animal component-free products?

  A: Yes, all GMP-grade proteins are made in an entirely animal component-free process (ACFP) using E. coli as the source under GMP compliance.