Technology Transfer Steps from R&D to Production in a Pharmaceutical Company

Abstract

Technology transfer (TT) from R&D to commercial manufacturing is a pivotal
process in the pharmaceutical industry, enabling the translation of laboratory-
scale innovations into scalable, compliant, and economically viable production.
This review provides a structured overview of the key steps in this transition,
highlighting critical success factors and potential challenges. The main phases
include: (1) Knowledge and Data Transfer, where formulation data, process
design, and analytical methods are compiled into a technology transfer dossier
(TTD) ; (2) Risk Assessment and Process Characterization, with tools such as
Failure Mode and Effects Analysis (FMEA) to identify critical quality attributes
(CQAs) and critical process parameters (CPPs) (3) Scale-up Strategy, involving
lab-to-pilot, pilotto-commercial scale batches and the development of scale-down
models ; (4) Analytical Method Transfer, validation, and verification in the new
production environment ; (5) Process Validation and Continued Process
Verification, including process qualification batches and design space verification
during commercialization ; (6) Documentation and Training, ensuring all
operating procedures (SOPs), control strategies, and personnel expertise are
aligned between R&D and manufacturing ; and (7) Handover & Lifecycle
Management, with feedback loops for continuous improvement and regulatory
compliance . Critical enablers include cross-functional governance, strong project
management, and a science- and risk-based Quality by Design (QbD) framework
. Despite its structured nature, TT faces various barriers such as equipment
incompatibility, communication gaps, and variability in raw materials.
Addressing these requires a proactive, well-documented, and collaborative
approach. This review concludes that a disciplined, knowledge-driven, and risk-
managed technology transfer not only ensures operational continuity anregulatory
readiness, but also helps maintain product quality and robustness across scale .