Cell therapy grade proteins with extensive QC
High-purity, animal origin-free proteins for cell and gene therapy manufacturing
Qkine manufacture a range of our high purity, bioactive animal origin-free growth factors and cytokines as Cell Therapy Grade with additional quality testing.Â
Qkine Cell Therapy Grade proteins are manufactured in our ISO 9001:2015-certified facility, located in Cambridge, UK. Manufacturing takes place in accordance with ISO 20399:2022 standard governing ancillary materials present during the production of cellular therapeutic products and gene therapy products and are GMP compliant.
Why use Qkine animal origin-free growth factors and cytokines for your cell therapy?
Certified animal origin-free
Utilizing animal origin-free recombinant proteins eliminates variations arising from trace animal components, promoting consistency during cell expansion. All our cell therapy grade proteins mitigate the risk of contamination by mammalian pathogens, enhancing the reliability of cell products.
Excellent lot-to-lot consistency
Qkine growth factors and cytokines have exceptional lot-to-lot consistency. Every lot is checked during a stringent QC process to ensure it has the same bioactivity as prior lots and to ensure reproducibility.
High level of purity with the lowest endotoxin level
We guarantee >98% purity due to assay limits, but we are confident that the true result is higher. To ensure purity, we always run an overloaded gel with 7 µg of protein to ensure that we can not visually detect any contaminants, aggregates, or degradants.
Additional quality testing
Building on the rigorous quality testing of sterility, endotoxin, bioactivity and purity for research use products, cell therapy grade products have additional quality testing such as host cell DNA, protein and N-terminal sequencing.
Quality standards
Qkine is IS0 9001:2015 accredited and operates using eQMS Software that is 21 CFR Part 11 compliant CTG products are manufactured in alignment with ISO 20399:2022 within an ISO 14644-compliant environment.
Documentation and support
Qkine provides Certificates of Analysis (CoAs), Certificates of Origin (CoOs), technical datasheets, risk assessments and regulatory support documentation upon request.
Animal origin-free manufacturing process control
As part of our ongoing commitment to quality in every aspect of the company, animal origin-free production is taken into consideration from the very earliest planning stages of design and development. Before being incorporated into a procedure, newly-sourced materials must be reviewed and approved by our Quality team.
We continuously work with our suppliers to confirm and certify that the chemical components used within the manufacture of Qkine products are derived from non-animal and non-human sources and that the processes and components used in their own manufacture are animal-free.
Every stage of the Qkine animal-free protein manufacturing employs Standard Operating Procedures (SOPs). SOPs are fundamental to assure consistency from lot to lot and guarantee the highest quality of products.
Qkine is ISO 9001:2015 certified for development, manufacture, and supply of proteins and related products.
Every component used during the manufacture of our products is assessed by our Quality team.
Research use vs cell therapy grade checklist
| Â |
RUOÂ |
CTGÂ |
| Certified animal origin-free |
✓ |
✓ |
| Manufactured in an ISO 9001:2015-certified facility with stringent in-process control measures |
✓ |
✓ |
| Consistent 95-115% protein recovery from vials |
✓ |
✓ |
| Lot-to-lot bioactivity testing |
✓ |
✓ |
| Protein purity >98% by SDS-PAGE and mass spectrometry |
✓ |
✓ |
| Protein identity, folding and dimer/monomer population confirmed |
✓ |
✓ |
| Tag free, carrier free |
✓ |
✓ |
|
Industry-leading low endotoxin levels <0.005 EU/µg protein |
✓ |
✓ |
| Sterile and mycoplasma negative |
✓ |
✓ |
| Â | Â | Â |
|
Beta-lactam free |
✓ |
✓ |
| Residual host cell DNA <10 ng/ml |
NAÂ |
✓ |
| Residual host cell protein <10 ng/ml |
NAÂ |
✓ |
| N-terminal sequence analysis |
NAÂ |
✓ |
| Specific activity IU/ng |
NAÂ |
✓ |
Animal-free certificates, certificates of origin (manufacture details), certificates of analysis (quality and bioactivity information) and MSDS are available for all products. Please request any documentation below.
Contact us
Our dedicated team of protein quality specialists is available to help and answer any questions you have about our cell and gene therapy grade products.