ST Cell Bank Characterization

Creative Bioarray offers Swine testis (ST) Cell Bank Characterization utilizing various techniques such as Fluorescent In Situ Hybridization (FISH), Locus Amplification & Sequencing and G-banded Karyotyping. Transgene Mapping through Locus Amplification & Sequencing integrates next-generation sequencing to selectively magnify and sequence the transgene and adjoining genomic area. G-banded Karyotyping can identify and examine chromosomal abnormalities like translocations, amplifications or deletions in ST cells, providing precious insights about the genetic stability of these cell lines. FISH possesses significant potential in detecting and analyzing ST cell lines. Its applications encompass verifying target gene integration and copy number, assessing chromosomal reorganizations, and quantifying specific gene expression levels. These applications significantly contribute to the progression and refinement of ST cell lines for biopharmaceutical production.

ST Cell Bank Characterization services from Creative Bioarray were provided to numerous pharmaceutical companies, and successfully helped their biopharmaceutical products get approved by the regulatory agency.

ST cell line was established in 1960 from the trypsinized testis of a normal 80-90 day old porcine foetus. The cells support the growth of various porcine parvo- and entero-viruses, and also pseudorabies virus. Also useful in the propagation and isolation of transmissible gastro-enteritis of swine. ST cells are regarded as one of cell lines most suitable for producing vaccines against pseudorabies virus.

Creative Bioarray has extensive experience in characterization of cGMP cell banks used in production. Our ST cell line characterization allows you to efficiently streamline your cGMP-compliant manufacturing processes and accelerate toward successful commercialization. And our reporting fulfils FDA and EMA regulatory requirements for pharmaceuticals for human use (ICH guidelines Q5B and Q5D, CTD Quality module, section 3.2.S.2.3).

ST Cell Line Characterization Tests Available:

Quotation and ordering

Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your ST Cell Bank Characterization partner.

References

1. Plavsic, Mark. "Q5D derivation and characterization of cell substrates used for production of biotechnological/biological products." ICH Quality Guidelines (2017): 375-393.
2. Galbraith, Daniel. "ICH Q5A: Viral Safety of Biotechnology Products." ICH Quality Guidelines: An Implementation Guide (2017): 311-335.
3. Krebs, Lara E., et al. "Effective and efficient characterization of Chinese hamster ovary production cell lines using automated intracellular staining and statistical modeling." Biotechnology Progress 34.3 (2018): 570-583.
4. Welch, J. (2017). Tilting at clones: A regulatory perspective on the importance of "Clonality" of mammalian cell banks. CDER/OPQ/OBP/DBRRIV April 24, 2017.
5. Paul Wu, et al. "Tools and methods for providing assurance of clonality for legacy cell lines" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018).
6. Frye, Christopher, et al. "Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines." Biologicals 44.2 (2016): 117-122.