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Integrating Critical Early Development Activities

By Susan Dana Jones

Integrating Critical Early Development Activities to progress From Clone to Clinic® cost-effectively is the theme of IBC’s newly launched track on Success Factors for Early Stage Biologics and the topic of what is sure to be a lively discussion panel hosted by BPTC. This track, part of the BioProcess International Conference & Exhibition held in Boston this fall, will take place on Wednesday October 22 starting at 10:30 AM. The content of this panel will range from funding strategies, manufacturing decisions, and “doing more with less,” all of which is designed specifically to provide management and staff of biotech start-up companies with a road-map of the “must-have”, “nice-to-have”, and “can be postponed without major risk” CMC development activities.

Many start-up biotech companies don’t have their own development capabilities and therefore seek the services of a qualified CRO or CMO to perform the different activities. However, it is the sponsor, not the CRO or CMO, who is responsible for the proper conduct of all development activities, the risk assessment of proceeding with a sub-optimal process, and the eventual quality of the product produced for human clinical evaluation. Managing the sponsor-CMO or CRO relationship is therefore a critical activity in developing new biopharmaceuticals. For biosimilar development, the sponsor company must be even more vigilant to insure that the CRO/CMO expectations and activities are fully aligned with the goal of designing a process to produce a product that is comparable in all the required ways to the reference, innovator product.

Cell line development is the first, and critical path, activity for any development program and this is a potentially lengthy activity for products that must be expressed in a mammalian system. With a multitude of options available through service providers and enabling technologies available through purchase or license, the decision of how and where to initiate this activity sets the strategy and risk profile for the entire development program. The history of the production cell line will be carefully reviewed by regulatory authorities worldwide and therefore any risks taken at this early stage could impact the eventual request to initiate trials in human subjects. Does this mean that cell line development must be lengthy and expensive? Not necessarily. We don’t believe that it needs to take more than 4-5 months to obtain a clonal, genetically stable, high expressing mammalian cell line for products that don’t require novel enzymatic processing, co-factors to assist in folding or secretion, or other unusual elements. The bigger question in early development is what else can be done while the cell lines are under construction?

The IBC track is focused on integration of all activities, minimization of upfront cash flow while mitigating the most likely risks in early development, and achieving a product that performs as desired in animals and patients. BPTC’s panel discussion at 4:30 PM will include seasoned industry veterans from both BPTC’s team of expert consultants and from companies developing novel, first-in-class or biobetter products. By drawing together experts in all aspects of early development and accessing the breadth of knowledge across this group, BPTC and IBC hope to implant the importance of well-managed, well-thought out development strategies starting with lead candidate selection through to delivery of the drug to patients in need of new therapies. If you still haven’t registered for the conference, you can register using BPTC’s discount code, BP14SKRE3, for 20% off the standard rates.