GMP compliant testing
GMP compliant testing for the full characterization of your investigational products
Our QC group has substantial experience in the testing of investigational biological products and of process intermediates such as raw materials, cell and virus banks, bulks and drug substances.
We ensure that the product manufactured in our facility meets regulatory requirements for quality attributes as identity, purity, potency and biosafety.
In-process and release testing
The Quality Control team ensures that the specifications defined for your product are met at the end of the process by performing in process and release testing for raw materials, consumables, cell banks, seed banks, intermediates, drug substances and drug products
Among expected capabilities, we have highlighted the following methods, generally applicable to virus-based biotherapies:
- Titration of infectious virus (CCID50)
- Viral antigen quantification by immunoassay (ELISA, Hemmaglutination)
- Cell-based assays, seroneutralization
- Protein content (µBCA, Bradford)
- Quantification of impurities:
- Residual host cell DNA by qPCR (commercial kits) with extraction
- Host cell proteins by ELISA (commercial kits)
- Residual BSA by ELISA (commercial kit)
- Residual Benzonase detection by ELISA (commercial kit)
- Protein characterization: SDS-PAGE, Western Blot
- Cell culture assays: seroneutralization, Test for effective inactivation
- Identification by qPCR, RT-PCR
- Formaldehyde content
The methods may be readily available, transferred in or specifically developed and validated by our team.
Clean Cells: biosafety testing and much more
GMP compliant biosafety testing is undertaken by our sister company Clean Cells, which has a track record of 20+ years in the characterization of all types of biophamarmaceuticals.
The safety testing services may include sterility, bioburden, mycoplasma testing both by cell culture and qPCR, adventitious viruses/agent testing either in vitro or by qPCR targeting specific extraneous agents.
Clean Cells also offers additional assays for the characterization of your product, including tests for identity (karyotyping, sequencing and PCR-based), purity and potency (cell-based).