CDMO selection and technology transfer

Song Consultancy supports biologics teams selecting a CDMO, transferring an upstream process to a new site, or planning a manufacturing transition. Frank helps assess process fit, documentation quality, receiving-site readiness, transfer risk, and the technical assumptions that affect development timelines, comparability, regulatory planning, and future supply. The work spans first CDMO selection, CDMO-to-CDMO moves, scale-up preparation, and manufacturing transition, including transitions that involve China-linked manufacturing exposure.

What Frank reviews

Frank reviews the current process, available documentation, upstream process parameters, scale-up assumptions, process history, and CDMO capabilities. He helps determine whether the receiving site has the technical fit, operational readiness, and documentation discipline needed for the program. For technology transfer, the goal is to determine whether the receiving site can execute the process, what technical or documentation gaps need to be closed, and what the transfer means for process qualification or validation planning, comparability, regulatory timing, and supply continuity.

Scope includes

• CDMO fit and capability assessment
• Current process and documentation review
• Upstream technology transfer planning
• Receiving-site readiness assessment
• Scale-up and process qualification or validation planning
• Comparability and regulatory filing impact assessment
• Technical communication with donor and receiving sites

Why transfers fail

Technology transfer often fails in the gap between the process as written and the process as understood. A process that performs at one site may behave differently at another because equipment, scale, mixing, aeration, control strategy, raw materials, and operating practices are not identical. The transfer package needs to communicate more than setpoints. It needs to communicate process understanding. Frank helps identify these risks early and supports a transfer plan that the receiving site can execute.

The China exposure question

BIOSECURE-related restrictions and broader geopolitical concerns have made China-linked manufacturing exposure a board-level issue for many biologics teams. Even where enforcement timelines are phased, the practical planning burden is already here. Site selection, technology transfer, process qualification or validation work, comparability assessment, and regulatory timing cannot be compressed at the last minute.

Where a program involves a China-based donor site or China-linked CDMO exposure, Song Consultancy helps assess the technical transfer path, identify CMC and supply risks, and support communication with the originating team before those risks become development delays.

Why Song Consultancy

Frank has hands-on experience in upstream process development and technology transfer, including programs advanced across sites in the US, China, and Australia. He has also operated inside China's biotech ecosystem and built and ran GMP cell culture media manufacturing facilities. That experience gives him a practical understanding of technical documentation, GMP operating expectations, China-based technical teams, and where process knowledge can get lost during handoff.

Common questions