PK15 Cell Bank Characterization

Creative Bioarray provides a comprehensive characterization of Porcine Kidney 15 (PK15) Cell Bank employing numerous methodologies such as Fluorescent In Situ Hybridization (FISH), Locus Amplification & Sequencing, and G-banded Karyotyping. The integration of next-generation sequencing in Transgene Mapping via Locus Amplification & Sequencing allows for the selective amplification and sequencing of the transgene and its adjacent genomic area. Abnormal chromosomal conditions like translocations, amplifications or deletions in PK15 cells can be detected and scrutinized using G-banded Karyotyping, offering valuable data regarding the genes' stability. FISH is a crucial tool in the examination and detection of PK15 cell lines with a wide range of applications, such as confirming target gene integration and copy number, evaluating chromosomal rearrangements, and measuring specific gene expressions. These significant contributions aid in the development and perfection of PK15 cell lines, vital for biopharmaceutical manufacturing.

PK-15 cells, originating from pigs who serve as primary hosts for multiple zoonotic viruses, are crucial resources for researching viral diseases and formulating cures, vaccines, and precautions to prevent disease epidemics.

PK15 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.

Creative Bioarray has extensive experience in characterization of cGMP cell banks used in production. Our PK15 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).

PK15 Cell Line Characterization Tests Available:

PK15 Cell Bank Characterization

  • PK15 Cell Line Clonality Assessment
  • PK15 Cell Line Genetic Stability (MCB, WCB, EOP) Testing
  • PK15 Cell Line Transgene Integrations & Copy Number QC (Locus Amplification & Sequencing)
  • PK15 Cell Line Transgene Integrations QC (FISH)
  • PK15 Cell Chromosomal Aberration Analysis

Cell Line Scope

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 PK15 cell bank characterization on the following cell lines:

  • Research Cell Bank (RCB)
  • Working Cell Bank (WCB)
  • Master Cell Bank (MCB)
  • End-of-Production Cells (EOPC)

Quotation and ordering

Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your PK15 Cell Bank Characterization partner.


  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.
All products and services on this website are only suitable for non-medical purposes.

Cell Line Characterization


Online Inquiry

Inquiry Basket ( 0 ) Choose Dye*