A comprehensive technology-transfer strategy has two primary purposes. First, it aligns technology transfer with broader corporate
strategies and ongoing business operations for managing product life cycles. Second, it guides where investments should be
made to ensure adequate process and organizational capabilities to support future product development efforts.
Like any good strategy, technology transfer should be customer-focused. This helps to align the requirements of the receiving
site, such as timing objectives for scale-up and transfer, with the sending site's processes and capabilities. Customer orientation
also helps ensure alignment of regulatory requirements and filing strategies.
To enhance the efficiency of transfers and minimize the risk of late-stage site changes, the two parties should be well matched
to begin with. Successful companies strategically select sites to match their product's technology, process, and capacity
requirements early in the development process. If a company wants to reduce costs, it should consider outsourcing some aspects
of manufacturing and analytical testing to suitable low-cost sites. If it is transferring products that require novel equipment
and technologies, it should consider early transfer of processes and methods to eliminate the risks of post-filing lot failures.
And if a company anticipates that the demand for the product will increase significantly, it should choose manufacturing sites
with upside capacity to avoid more transfers in the future.
Figure 3. Overview of technology transfer stages
Consider the example of a generics pharmaceutical company that wished to cut costs by consolidating its manufacturing base,
transferring production to lower-cost locations, and improving its capacity utilization. After evaluating its options, the
company decided to transfer its US manufacturing operations to two European sites. The challenge was formidable: how to transition
the manufacturing of some 40 molecules—roughly half of the company's entire production volume—across the Atlantic to sites
with different operational practices and culture, and little familiarity with FDA regulations? Neither the US facility nor
its European counterparts had much experience managing complex transfers or expanded supply chains.
To meet this challenge, the company adopted a holistic approach. First, its board of directors established cost-savings objectives
for the transfer. A steering committee, consisting of senior executives from the sending and receiving sites, was formed to
determine the operating budget, resource requirements, capital investment, and timeline for realizing the cost savings. The
committee helped frame the overall operational strategy, including transfer sequencing, risk mitigation, and process changes.
The transfer sequencing and prioritization strategy called for an early transfer of high-volume, high-cost products to cut
costs early and ensure dual capacity at sending and receiving sites to prevent supply disruptions. To reduce the probability
of unexpected technical problems down the line, the steering committee formulated a risk-mitigation strategy focused on transferring
the most challenging drug potencies of a product first. The less-complicated potencies could then be transferred faster by
leveraging process synergies and lessons learned from earlier transfers. In addition, the project transfer teams established
guidelines to capture significant process improvements following the initial transfer. This approach was designed to ensure
that no major process changes were made during the transfer, allowing the company to file a significant number of products
with CBE-30 status. This status helped to accelerate the health authorities' review process and, ultimately, had the potential
to reduce the time for approval of commercial manufacturing from nine to 12 months, to just one month. To implement the new
operational strategy, the project transfer teams created a detailed implementation road map.
THE ROAD MAP
Typically, technology transfer occurs during one of five stages in the product's lifecycle: molecule discovery, toxicological
evaluation, clinical development, scale-up and commercial manufacturing, and in-line production. Each stage involves a different
type of transfer, rationale, and key participants (Figure 2).
Each stage also requires a road map to translate the transfer strategy into specific activities, to define the timing, sequence,
and dependencies among these activities, and to identify the stakeholder responsibilities and deliverables.