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22 Gerson et al. TRANSFER GOALS To function effectively, all of these inputs The goals for this new methodology were to ensure that in future projects for the transfer of candidate processes from development to manufacturing, there would be standardized protocols for transfer applicable to all prod- uct lines. The objective was to provide instruction for the group involved in the transfer on how to organize and plan their tasks, but not to provide instruction in engineering or other technical areas. Key features of this included the following: and outputs must participate in the transfer process; to function efficiently, the interac- tions must be managed with wisdom and knowledge to optimize the flows of information as well as the use of resources and the consumption of time. The older, simplistic concept that small groups in development could just tell engineering to build a plant that manufacturing would then use, resulted in many failures, usually expensive. The high knowledge con- tent of modern drug and vaccine manufactur- • A fully documented transfer, • The basis for the development of realistic estimates for the time and resources required for the transfer to manufacturing, • The technical basis for a reproducible process at both pilot and manufacturing scales, and • The technical, analytical, engineering, and operational basis for the production of sucing processes, and the concomitant complexity of these transfer projects, demands the use of an interactive, consultative, creative approach, bounded by adequate structure and discipline. By working closely with both suppliers and customers, transfer teams achieve a high rate of success. cessful consistency lots in the new manu- THE OLD WAY facturing facility. Analysis of case studies clearly revealed that THE CUSTOMER/SUPPLIER ANALYSIS PROCESS previous methodologies for the transfer from development to manufacturing resulted from a natural evolutionary process, not an analyt- The transition from development to manuical predetermined process. Transfer projects facturing is a highly complex nexus with con- were highly dependent on individuals in- nections to nearly all other operational asvolved in a particular project, and were often pects of the business. Internal suppliers of dominated by the most forceful personality information and materials to this business of a group. The result was frequently prob- process are primarily development, engineer- lematic and misdirected, an incomplete ing, and quality, but secondary suppliers in- patchwork with overemphasis in some areas clude finance and accounting, validation, and neglect of others. The greatest impedi- purchasing, safety, personnel, and environments to success were typically the ‘things ment. External suppliers include construction left out,’ omitted for lack of representation or contractors, equipment vendors, and raw ma- effective participation by key functionalities. terials manufacturers. The primary internal The cases analyzed ranged from ‘perfectly’ customers of the process of transferring from executed projects, on time and under budget, development to manufacturing include man- to chaotic projects, far over budget and time, ufacturing, regulatory, and quality; second- with either type of project resulting in dysary customers include engineering, main- functional manufacturing processes and tenance, validation, process improvement, plants. While occasionally the transfer went marketing, and materials management. The well enough, case studies clearly indicated primary external customer is the recipient of that a predetermined, organized approach to the license application, the Food and Drug technology transfer was required to provide Administration (FDA) or a board of health. direction to future transfer projects.
Transfer of Processes from Development to Manufacturing 23 THE REDESIGN on the technology transfer process, so that Analysis of the case studies revealed key ele- ments required for improved transfers from development to manufacturing. These were: each member is thoroughly familiar with both the business methodology to be used and the technical aspects of the process being transferred. The team members must then be • Technology transfer team, • Transfer document, • Production scale qualification, • Training development and manufacturing, • Transfer project champion, and • Formalized regulatory communication. trained on the use of the process tools (eg, database) to help organize and assemble numerical data, assign action items, determine the current level of readiness, and identify areas of weakness or omission. At this point it is possible to define and follow a reasonable course of action. For instance, the technology transfer team TECHNOLOGY TRANSFER TEAM (T for a prototype biotechnological process would include representation from: 3 ) The technology transfer team is a cross-func- • Fermentation, tional team representing all departments, • Purification, suppliers, and customers involved in the • Chemistry, transfer. Each representative provides infor- • Formulation, mation on his/her functional area’s needs, • Fill-pack, works on action items, organizes and directs • Quality assurance/quality control, work on his/her aspect of the project, and • Engineering, and supplies information to the team that is expected to impact other areas. • Regulatory. Given the complexity of pharmaceutical manufacturing processes, the technology transfer team requires appropriate resources TECHNOLOGY TRANSFER DOCUMENT and tools to accomplish the task. An impor- A key task of the technology transfer team is tant tool is the team leader’s database. With to orchestrate the writing of a comprehensive an effectively and professionally organized technology transfer document. Traditionally, relational database, information required for ‘transmittal documents’ have been used to the project can be stored and selectively re- tell engineering how to build a plant or to tell called with relative ease. Simple lists or manufacturing how to run a process. Such spreadsheets lock information into particular documents have rarely been sufficient, as the formats and relationships in ways that require ‘know how’ was usually inflexible and pe- significant effort to reorganize. Relational ripheral information was lacking, leaving databases allow the reassortment of informa- crucial questions relating to scale-up or techtion with remarkable ease and are invaluable nology unanswered. tools for effective project management. A successful technology transfer docu- Clearly, if technical assistance is required to ment contains both “know how” and “know develop, maintain, and use the database, it why.” With antecedent and peripheral infor- should be provided to the extent that the ben- mation, members of the technology transfer efits outweigh the costs. team have more to work with, can better As soon as management decides to trans- evaluate options (which type of pump or filfer a given process from development to ter is required?), and can distinguish the criti- manufacturing, the development project cal from the incidental. This document is to team should meet and establish the technol- provide all relevant information so that the ogy transfer team. The team is then trained transfer goes easily and smoothly, future
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