Technology Transfer and CMO Site Transfer of Pharmaceutical Products: Strengthening Saudi Arabia’s Local Manufacturing Capacity

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@article{1722494,
      author = {Naseer Mitaigiri},
      title = {Technology Transfer and CMO Site Transfer of Pharmaceutical Products: Strengthening Saudi Arabia’s Local Manufacturing Capacity},
      journal = {Iconic Research And Engineering Journals},
      year = {2026},
      volume = {10},
      number = {2},
      pages = {2374-2385},
      issn = {2456-8880},
      url = {https://www.irejournals.com/formatedpaper/1722494.pdf},
      abstract = {Saudi Arabia is advancing pharmaceutical localization as part of a wider strategy encompassing health security, industrial diversification, and biotechnology development. However, localization achieves strategic significance only when the receiving manufacturer attains reproducible process knowledge, analytical control, quality-system ownership, and the capacity to sustain commercial supply. This review thoroughly examines pharmaceutical technology transfer and contract manufacturing/development organization (CMO/CDMO) site transfer as mechanisms to enhance local pharmaceutical manufacturing capacity in Saudi Arabia. A structured integrative review of literature and credible regulatory or policy sources published between 2020 and 2025 was conducted, focusing on manufacturing science, analytical transfer, quality risk management, lifecycle regulation, outsourced manufacturing, and Saudi localization policy. The evidence demonstrates that successful transfer involves a controlled transformation of explicit and tacit product knowledge into site-specific operational capability, rather than a mere exchange of documents. Key determinants include early CMO fit assessment, comprehensive technology packages, equipment and facility comparability, analytical method transfer, risk-based scale bridging, process performance qualification, stability commitments, data validity, and ongoing post-launch process verification. Effective CMO governance is also essential, as fragmented responsibilities, inadequate quality agreements, or delayed knowledge exchange can escalate technical differences into validation failures and supply disruptions. For Saudi Arabia, a staged localization model is proposed that corresponds transfer maturity with workforce development, supplier localization, digital quality systems, regulatory preparedness, and progressively higher-value manufacturing. The review concludes that technology transfer can serve as an instrument for industrial capability-building when success is evaluated by local process ownership, right-first-time performance, resilient supply, and the receiver’s capacity to independently manage future lifecycle changes, as opposed to solely by the release of the first commercial batch.},
      keywords = {technology transfer, CMO, CDMO, pharmaceutical manufacturing, localization, saudi arabia, vision 2030, GMP, process validation, supply resilience.},
      month = {August},
      doi = {https://doi.org/10.64388/IREV10I2-1722494}
  }