Cell Therapy Scale-Up and CDMO Staff Reductions Trigger Critical Process Know-How Loss in Tech Transfer

June 28, 2026

Drug Discovery and Development USA

Overview

The scaling of cell therapies, coupled with staffing changes at Contract Development and Manufacturing Organizations (CDMOs), is leading to a significant loss of critical process know-how during technology transfer. Advanced modalities like cell and gene therapies inherently involve increased biological variability, complex potency assays, and high sensitivity to operator technique, making transfers exceptionally demanding. This issue directly impacts yield and product quality in CAR-T manufacturing, underscoring the urgent need for early transfer design, institutionalized knowledge management, and robust analytical readiness.

In Depth

Key Findings

A critical issue emerging within the rapidly expanding cell therapy sector is the loss of invaluable process know-how during technology transfer, exacerbated by the simultaneous scaling of manufacturing operations and staff reductions at Contract Development and Manufacturing Organizations (CDMOs). Modalities such as cell and gene therapies present unique challenges, including inherent biological variability, intricate potency assays, and a high dependence on operator technique, making the transfer of manufacturing processes particularly arduous. This erosion of expertise directly compromises yields and product quality in CAR-T manufacturing, highlighting a systemic vulnerability in the industry’s ability to maintain efficiency and safety.

Technical / Clinical Details

Cell and gene therapy manufacturing processes are considerably more complex and variable than traditional pharmaceutical production. Subtle differences in conditions at each step—from cell isolation and gene transduction to expansion, harvest, and final formulation—can profoundly affect the quality and yield of the end product. Given the patient-to-patient variability in biological responses, standardized protocols alone are often insufficient; the nuanced, empirical ‘know-how’ and informal knowledge accumulated during process development by experienced operators are indispensable. During technology transfer, converting this tacit knowledge into explicit, systematically documented procedures is crucial but frequently hindered by staff turnover and organizational restructuring.

Background & Context

The cell and gene therapy market is experiencing explosive growth, necessitating large-scale and efficient manufacturing to achieve commercialization and broad patient access. CDMOs play a vital role in meeting this demand, but cost pressures and market dynamics often lead to organizational changes that result in the attrition of experienced personnel. The loss of such expertise not only decreases operational efficiency but also creates regulatory hurdles, delaying critical therapies from reaching patients. This represents a significant supply chain risk, with potential life-threatening implications for patients.

Strategic Significance & Outlook

Addressing this challenge requires an urgent focus on strategic design of technology transfer processes from early stages, strengthening knowledge management systems, and ensuring robust analytical readiness. Specific interventions include developing knowledge databases utilizing digital tools, implementing continuous training programs, and fostering closer collaboration between CDMOs and client companies. By adopting these measures, the industry can ensure the quality and safety of cell therapy products while simultaneously achieving efficient manufacturing and rapid patient delivery. A concerted effort across the industry to protect and share vital know-how is anticipated.

Source: https://www.drugdiscoverytrends.com/as-cell-therapies-scale-and-cdmos-cut-staff-the-know-how-that-makes-them-work-often-isnt-transferring/

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