BHK-21 Cell Bank Characterization

Biologically derived drugs have become a major part of the current pharmaceutical industry. Among the industrial cell lines used for producing approved biologics, the mammalian cell lines encompass 5% of them. And among these mammalian cell lines, BHK-21 cell line has found applications at large scale in veterinarian viral vaccines against foot-and-mouth disease and rabies virus, as well as heterologous protein production (Factor VIII).

Creative Bioarray has extensive experience in characterization of cGMP BHK-21 cell banks used in production of biologic drugs. Our BHK-21 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).

BHK-21 Cell Line Characterization Tests Available:

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 BHK-21 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)

Cell Bank characterization is an essential step in ensuring the safety of biopharmaceutical products with the aim of confirming the identity, purity and genetic stability of cell lines. This characterization can ensure that the cell banks are free of contaminants and are able to provide a solid, stable foundation to continue production process years down the road. International regulatory guidelines such as ICH (Q5A, Q5B, Q5D), EP and USP for cell lines characterization mainly focus on four areas:

  • The origin and history of the cell line cellular morphology and growth characteristics
  • Purity of the cell lines (i.e., absence of contaminating cells, microbial contaminations, and contaminations by adventitious viruses)
  • Tumorigenicity and oncogenicity
  • Genetic Stability

Mammalian Cell Line Characterization- Recommended Testing Plan

Microbial ContaminationSterility+++

Cell Line Stability/IdentityDNA Fingerprinting/Barcoding+++

Genetic StabilityDNA Sequencing+

Gene Copy Number+

Restriction Endonuclease Analysis+

In vitro Adventitious Viruses+++

In vivo Adventitious Viruses+

Virus Detection by PCR (e.g., Human, Simian, Bovine, Murine, and Porcine)+

Mouse, Hamster, and Rat Antibody Production Assays (MAP, RAP, and HAP)+

Transmission Electron Microscopy+

Quotation and ordering

Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your BHK-21 Cell Bank Characterization Service 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. 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.
  4. 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).
  5. Frye, Christopher, et al. "Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines." Biologicals 44.2 (2016): 117-122.
  6. Dangi, A. K. Cell Line Techniques and Gene Editing Tools for Antibody Production: A Review. Front Pharmacol. 2018; 9: 630. doi: 10.3389/fphar.2018.00630
All products and services on this website are only suitable for non-medical purposes.

Cell Line Characterization


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