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Recombinant protein therapeutics, or biologics, are an important class of pharmaceuticals for which Chinese Hamster Ovary (CHO) cells are the most commonly used expression system. Assessment of clonality remains a key factor in the development of any new stable cell lines for novel biopharmaceuticals or biosimilars.
In recent years proof of clonality has become a focus for the FDA and other regulatory authorities. Many companies have received comments back on this topic during the IND review process of their biological products. Clonality is thought to minimize the heterogeneity of cell banks and thus allow for consistent manufacture a product.
This is the primary concern for drug developers and is governed by the FDA/EMA and other regulatory bodies. Documentation of clonality is encouraged as part of IND process and is mandatory by the time of BLA (Biological Licence Application).
"It is expected that clonal cell lines are developed as referenced by ICH Q5D and EMA/CHMP"
Rachel Novak, US FDA, Jan 2017
Recent developments such as single cell sorting and high-throughput imaging allow for the acquisition of evidence supporting clonality. Rederiving a clonal cell line by additional limited dilutions is time-consuming, costly and, crucially, may affect production and growth rates of cell lines. This is especially undesired when time lines for submission are short. Creative Bioarray provides the genetic characterization of (CHO) producer cell lines by FISH, which offers information on transgene integrity and integration sites.
Creative Bioarray's Clonality Analysis Service (FISH) has the following Features: