The Planning stage of technology transfer (TT) is crucial for ensuring a seamless transition of processes, resources, and knowledge from the Sending Unit (SU) to the Receiving Unit (RU). However, this stage involves complex coordination across functional groups, each with unique roles and responsibilities. This blog explores the key activities and responsibilities of each function during the Planning stage to provide a comprehensive understanding of the meticulous efforts required for successful technology transfer.
An Overview of the Planning Stage
The Planning stage of technology transfer (TT) begins following the site selection and initial charter approval. This critical phase involves assembling the TT team, performing comprehensive risk assessments, and developing a detailed project plan. Next, let’s look at and outline the key roles and associated activities that ensure a successful transition to the Knowledge Transfer stage.
Key Roles and Activities
Business Functions
The Marketing Authorization Holder (MAH) Business function plays a crucial role in coordinating with the Sourcing/Supply Chain function to execute essential supply agreements, such as Master Service Agreements, with the Receiving Unit (RU) and external laboratories. These agreements must align with the TT charter and support the quality requirements. The TT Project Manager (TT PM) reviews these agreements to ensure consistency and feasibility.
Business functions, alongside the steering committee, provide oversight by approving resource and capital needs. They develop a comprehensive resource plan based on personnel requirements, equipment needs, expertise levels, and technical complexities. Additionally, the Business function offers input on the regulatory strategy, focusing on volume requirements, market release timing, and the salability of validation batches.
Technology Transfer Project Manager (TT PM)
The TT PM is assigned once the Business function determines the TT will proceed. This individual provides overall leadership and accountability, coordinating the project across all functional areas. The TT PM establishes a cross-functional team to plan and assess knowledge transfer requirements, working closely with both the Sending Unit (SU) and RU to define roles and responsibilities.
A crucial aspect of the TT PM’s role is developing the project plan, which includes scheduling, critical path activities, and resource needs. This plan covers capital procurement, material procurement, process development, analytical method validation, operational readiness, and process validation. The TT PM also ensures the project aligns with business needs and stakeholder expectations, expanding the TT charter to include a communication plan for effective knowledge transfer and issue resolution.
Process Function
During the Planning stage, the Process function specifies the commercial manufacturing process, including batch scale, unit operations, cycle time, and material handling requirements. This leads to the creation of an initial bill of materials, supporting production planning and plant logistics.
The Process function aligns Quality Target Product Profile (QTPP) and specifications with the RU and develops a comparability plan to ensure product consistency across sites. Detailed risk assessments are performed to define necessary changes at the RU, considering equipment, scale, and capabilities. These assessments inform capital requirements and ensure the process runs reproducibly at the RU, meeting QTPP and specification standards.
Working with Quality and Regulatory functions, the Process function defines process and cleaning validation strategies and aligns change control processes between the SU and RU. They also issue change requests within the change management system to facilitate the TT.
Analytical Function
The Analytical function conducts detailed risk assessments to finalize analytical equipment requirements and determine testing sites, which may be located at the SU, RU, MAH, or external laboratories. These assessments cover raw materials, packaging, in-process controls, product stability, and cleaning test requirements.
Adequate quantities of source materials, reference standards, and critical analytical reagents are estimated for method validation and future manufacturing. An initial sampling plan is developed, detailing sample locations, quantities, and testing requirements. This plan helps allocate adequate analytical resources during qualification.
Engineering Function
The Engineering function collaborates closely with the Process function to develop capital requirements for the RU, documented in a capital appropriation request (CAR). They may need to order long-lead equipment early to meet TT timing requirements and manage change control for facility and laboratory modifications.
If the RU is a contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO), the Engineering responsibilities may reside at the contract site, with strong oversight from the TT Team. The TT PM coordinates with Engineering to align equipment and facility installation, qualification, and training with the overall project plan.
Manufacturing Function
Manufacturing ensures the project timeline includes all necessary steps for full operational readiness of the RU site. They consider operational requirements relative to staff capabilities, permit requirements, and necessary training for the new process and modified facility. Manufacturing works with Engineering and Process units on plant design, defining user requirements specifications (URS) and CAR requirements.
Environmental, Health, and Safety (EHS) considerations are assessed against RU procedures, preparing necessary permits and evaluating protective equipment, biosafety, aseptic practices, hazardous materials, and potential waste streams. Reports on operational requirements and EHS assessments are included in the project plan.
Regulatory Function
The Regulatory function refines the regulatory strategy, identifying items that impact the product strategy. This strategy includes a projected timeline for key milestones, regulatory risks, and mitigation options. Collaboration between MAH and RU Regulatory and Quality functions is crucial for understanding risk tolerance and concerns, ensuring a smooth process.
Regulatory communicates submission requirements to Process, Analytical, Engineering, and Manufacturing functions, facilitating detailed risk assessments. They may also meet with regulatory authorities to review the strategy, ensuring success. The RU Regulatory function works with MAH Regulatory to obtain current CMC information and understand any changes across the product lifecycle.
Quality Function
The MAH Quality function collaborates with the RU Process function to document QTPP and product specifications, ensuring quality, safety, and efficacy. Quality agreements are developed and executed between MAH, RU, and additional GMP providers and external laboratories.
Quality works with Process, Analytical, and Regulatory functions to prepare stability requirements and ensure GMP audit-readiness at the RU. An initial audit identifies compliance gaps impacting the TT, addressed before implementation. Quality also performs a gap assessment of SU, RU, and MAH quality systems, aligning the Quality Management System (QMS) for the TT.
Sourcing/Supply Chain Function
Production planning begins once the TT decision is made, with Sourcing/Supply Chain evaluating the time needed for TT activities, including engineering batches, qualification batches, stability studies, and regulatory approvals. They consider planned production downtime and target market volumes to determine RU capacity and resource needs.
Sourcing raw materials, consumables, and packaging components starts with identifying long-lead items and sole-sourced materials. Changes to critical materials identified in the TT risk assessment are addressed. The Sourcing/Supply Chain function develops a product supply chain strategy, considering import/export considerations, distribution, and interim points for product and materials. A detailed supply chain map identifies risks and facilitates future troubleshooting.
The Road to Successful Technology Transfer
In summary, the Planning stage of TT involves meticulous coordination and collaboration across multiple functions, each playing a vital role in risk assessment, resource planning, and project execution. This stage sets the foundation for a successful Knowledge Transfer, ensuring that all aspects of the project are aligned and ready for the next phase.
Follow CAI’s Tech Transfer blog series as we step through each of the stages of an effective technology transfer shown below.
