Platform process will give platform product - Can we afford it?

Introduction Manufacturing processes for therapeutic monoclonal antibodies (mAbs) have evolved immensely in the past two decades around two major thrust areas. 1) Advancements in a) Cell line developmentbreakthrough and incremental knowledge gain in technology b) Media and feed formulation strategies c) Advent of Disposables and Instrumentation technologies thus offering significant improvements to Process Development (PD). 2) Establishment of platform processes to leverage faster PD [1,2]. A platform process generally consists of a standard i) Cell line development technique, ii) Basal medium and feeds, iii) Process parameters and scale-up approach. The biggest advantage of using the platform process for the PD group is in expediting the project timelines. The platform approach also benefits from well-established and validated work flows in Manufacturing, QA, QC and Supply-chain groups. Certain disadvantages have also been cited for the platform approach. For example, modifications in the platform process are generally discouraged due to time, cost and efforts required in accommodating such changes. Also, as process conditions can substantially impact the product quality (PQ) attributes, a platform approach does not allow any significant changes in the PQ attributes, if desired.