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).
According to document ICH Q5D 'Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products', Creative Bioarray performs MDCK cell bank characterization on the following cell lines:
Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your ST Cell Bank Characterization partner.