Published By : 05 Jan 2016 | Published By : QYRESEARCH
Biotherapeutic drugs are mostly recombinant monoclonal antibodies, widely produced in mammalian cell lines. The production of recombinant monoclonal antibodies in mammalian cell lines is due to the requirement for post translational modifications that should be alike or at least very similar to those found in humans. With many biopharmaceutical drugs reaching later stage clinical trials, the demand for biotherapeutics cell line development is increasing rapidly. Advancements in upstream processing technologies have led to highly productive cell line for large scale production of protein therapeutics. All these factors have largely contributed to the growth of the global biotherapeutics cell line development market.
Recently, the U.S. Food and Drug Administration (FDA) has stated that biopharma companies need to provide details about the selection and optimization of new clones. If they are unable to offer detailed evidence, the FDA will implement additional controls on manufacturing and other aspects of the product quality control strategy. This would imply additional manufacturing steps with costly delays to a clinical trial or drug launch. Though the FDA’s step has been welcomed by some quarters of medical fraternity, biopharma companies are struggling to provide details of selection and optimization of new clones.
The difficulty to provide cloning details by biopharma companies can be attributed to the traditional method of single cell cloning. Among single cell cloning methods, ClonePix is the most widely adopted method by biopharma companies. The traditional method of single cell cloning has multiple disadvantages such as identifying and tracking hundreds of cell colonies to determine a high-producing clone. This requires a lot of time and relies heavily on a scientist’s skill level. To address this issue, cell metric platforms are being introduced. Equipped with illumination technology and camera, these platforms make it easier to distinguish the single cell colonies. This is expected to make life easier for biopharma companies as they would be able to offer cloning details to regulatory authorities.