Clone Identification

Creating and selecting a promising clone from thousands of cells requires thorough understanding of the reference product and deep scientific capabilities.1

In order to select the best clone to produce a biosimilar, scientists must match, as closely as possible, the critical quality attributes and, most importantly, the biological function of the reference product.2

To best match these attributes, hundreds to thousands of cells are evaluated using an extensive screening process to identify the one that will produce a biosimilar of the highest functional similarity. The process includes:

  • Candidate clone evaluation
  • Transfection and amplification
  • Clone selection
  • Product and process optimization 


References:

  1. Desanvicente-Celis Z, Gomez-Lopez A, Anaya J-M. Similar biotherapeutic products: overview and reflections. Immunother. 2012;4:1841-1857.
  2. Conner J, Wuchterl D, Lopez M, et al. The biomanufacturing of biotechnology products. In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Waltham, MA: Academic Press; 2014:351-385.
  3. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies. Drugs. 2011;71:1527-1536.
  4. Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28:363-372.