The successful transfer of a monoclonal antibody (mAb) drug product from late-stage clinical development to commercial-scale manufacturing is a pivotal milestone in biopharmaceutical development. Technology transfer (tech transfer) involves the systematic movement of development activities, manufacturing processes, analytical methods, and quality control strategies from a sending site, typically a develop ment or clinical-scale facility, to a receiving site, which is often a large scale or commercial production facility. For Contract Development and Manu facturing Organisations (CDMOs), tech transfer is not just a process of replicating manufacturing steps at a different facility; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

At the late-stage clinical phase, the goal shifts from producing limited quantities for clinical trials to establishing a scalable, reproducible, and commercially viable process capable of producing consistent, high-quality batches. This transition requires a strategic approach to process knowledge transfer, analytical method transfer and validation, facility fit assessment, supply chain logistics, and regulatory alignment. Additionally, the challenges of scaling up a mAb process are significant due to their structural heterogeneity, immunogenicity risks, specific formulation requirements, and involve considerations such as purification efficiencies, formulation stability, and aseptic fill-finish operations.

CDMOs must also anticipate regulatory expectations to ensure compliance with global health authorities such as the FDA, EMA, and PMDA. Each jurisdiction has specific regulatory frameworks regarding process validation, comparability studies, and quality assurance – all of which must be thoroughly addressed to support a seamless transition to commercial production.