![GMP Proteins]( "GMP Proteins")
GMP Proteins
Transitioning catalog proteins from RUO to GMP grade
GMP Regulations
- USP <1043> Ancillary Materials for Cell, Gene, and Tissue-engineered Products
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- NMPA: Technical guidelines for pharmaceutical research and evaluation of immune cell engineered products
- Guideline and procedure specified in Chinese Pharmacopeia: rigorous analytical method development and
validation process
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 Workflow
* 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.
Protein Search
Alphabetical Listing of Proteins:
