Analytical Control Strategy for Biologics. Part II: Roadmap for Development and Implementation.

Abstract

Biologics therapeutics encompass different modalities with vastly different molecular profiles. However, there are many similarities in the integrated product control strategy development that may be applied across the different modalities, including establishing Quality Target Product Profile (QTPP), drug substance and product development, analytical method development and qualification, process performance qualification, analytical method validation and continuous process verification. Technical and regulatory requirements for biologics development are established in numerous regulatory guidance documents issued by industry experts, ICH, FDA, EMA, and other health authorities. While there is substantial published knowledge on specific studies needed for the development of a product, there is no specific guidance on establishing a comprehensive analytical control strategy as part of an integrated control strategy in alignment with the lifecycle of product development from pre-clinical through commercialization of human biotherapeutics. This commentary is part II of a two-part commentary series on analytical control strategy development and implementation. In part I, we presented the foundations of a well-developed analytical control strategy. In this part, we present a streamlined and stage-appropriate roadmap for developing and implementing the key elements of an analytical control strategy from pre-clinical to commercial launch of therapeutic biologics.