The bioprocessing industry uses recombinant mammalian cell lines to generate therapeutic
biologic drugs. To ensure consistent product quality of the therapeutic proteins, it is …

In recent years, assurance of clonality of the production cell line has been emphasized by
health authorities during review of regulatory submissions. When insufficient assurance of …

Recently, several health authorities have requested substantial detail from sponsor firms
regarding the practices employed to generate the production cell line for recombinant DNA …

Cell lines used for the manufacture of recombinant proteins are expected to arise from a
single cell as a control strategy to limit variability and ensure consistent protein production …

There has been much recent focus on the regulatory emphasis and the relative importance
surrounding clonal derivation of mammalian production cell lines used in the manufacture of …

Regulatory guidelines require the sponsors to provide assurance of clonality of the
production cell line, and when such evidence is not available, additional studies are typically …

Establishing that a cell line was derived from a single cell progenitor and defined as clonally‐
derived for the production of clinical and commercial therapeutic protein drugs has been the …

• Regulatory expectations for assurance of clonality of the production cell bank used in the
manufacture of Biotech products• Commonly used cloning procedures and the …

Continuous mammalian cell lines, such as Chinese hamster ovary (CHO), NS0 and baby
hamster kidney (BHK) cells, are valuable host cells for the generation of recombinant …

Cell cloning and subsequent process development activities are on the critical path directly
impacting the timeline for advancement of next generation therapies to patients with unmet …