Analytical method lifecycle is a continuous process that improves and documents the understanding of the capabilities of each
analytical method used throughout the clinical development of a new drug candidate. Of key importance, analytical lifecycle-related
activities have to be appropriately staged in accordance with the regulatory requirements without neglecting the financial
and time constraints incurred by each project. Currently, regulatory requirements for analytical methods are primarily directed
at prerequisites for commercial manufacturing, the end point of the development process, without any description of requirements
regarding the stepwise development leading to validation. This article proposes an analytical lifecycle roadmap that will
stage the various steps involved in analytical method development while attempting to meet the expectations of the stakeholders
involved in the management of project risk, development costs, and regulatory compliance.
Despite the growing quality-by-design (QbD) trends that promote accumulating characterization data from early clinical development,
a number of biotech companies are constrained to demonstrate early positive clinical results within a shorter timeframe and
with less money than before. Often, these companies have a business model to sell or license the product under clinical development
to a larger pharmaceutical company for final development and marketing. The value of the product will then be determined by
a number of factors including indication, product safety/efficacy data, and process development status.
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Biotech and pharmaceutical companies involved in the process development and clinical manufacturing of a new biologic drug
candidate have to achieve the right balance between development goals and inherent project risk, cost, and regulatory compliance
at the different stages of clinical development (see Table I). The development strategy should therefore rely on phase-dependent yet flexible business decisions that take into account
all the elements of risk mitigation, cost balance, and compliance towards regulatory requirements, an approach that will of
course affect the different aspects of analytical work. In this context, a lifecycle approach has the benefit of offering
a long-term vision of the project associated with sustainable business decisions to the stakeholders involved.
Table I: Project overview in clinical development.
Analytical method lifecycle refers to the combined activities of analytical method development, improvement, qualification,
validation, transfer, and maintenance related to GMP production. An integrated approach to analytical lifecycle must ensure
that analytical methods evolve from initial development to commercial use in a manner that is best suited for their intended
use at the various clinical stages on the way to commercialization. Building an analytical lifecycle roadmap that satisfies
all requirements must be supported by strong technical expertise as well as sound business and regulatory knowledge.