Kymanox has created a set of Universal Technology Transfer Templates available from our KymaSTORE.™ Take a look at our offerings:
- Analytical Assay Summary Template - This template package features a universal Analytical Assay Summary template that can be used to provide the most up-to-date information on all assays used for in-process testing, lot release, characterization, raw material testing, and other assays related to a specific process requiring technology transfer.
- Bill of Materials Template - This template package features a universal Bill of Materials template that can be used to provide the most complete information on all components, raw materials, consumables, reagents, and biologic materials.
- Biologic Material Transfer Log Template - This template package features a universal Biologic Material Transfer Log template that can be used to document the transfer of cells and intermediates in various stages of processing, including purified product and reference standard. The log provides basic information on the origin, nature, and key biological and safety properties of the materials in question.
- Change Management Template - This template package features a universal Change Management template that can be used to provide information on both contemplated and actual modifications to the process and/or its components in a controlled and documented manner.
- Equipment List Template - This template package features a universal Equipment List template that can be used to provide the most complete information on all critical and auxiliary systems for the transferred manufacturing process and associated testing.
- Sampling Plan Template - This template package features a universal Sampling Plan template that can be used to provide information on quantity, size, and nature of samples of materials to be collected at various stages or unit operations for process control, release, or informational purposes. This template is especially useful for technology transfers.
- Solution Formulation Template - This template package features a universal Solution Formulation template that can be used to outline the minimum requirements for the successful transfer of information necessary for the preparation of buffers, media, and other solutions.
- Writing Assay Transfer Plans Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Plans, which provide information on assays requiring transfer, activities related to assay qualification at the receiver site, as well as expected results and specifications. The procedure also includes appropriate example tables to provide further guidance on creating the document.
- Writing Assay Transfer Reports Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Reports, which provide documented proof that transferred assays perform at the receiver's facility and in the receiver's hands acceptably and comparably with the sender. The reports summarize the results of executed qualification protocols for each transferred assay.
- Writing Detailed Process Descriptions Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product. The procedure also includes appropriate example tables to provide further guidance on creating the document.
- Writing Experiment Reports Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Experiment Reports, which document the details of an individual experiment or trial performed as part of a process transfer. Experiment Reports provide the rationale for performing the experiment, as well as a brief description of materials, equipment, procedure, results, and conclusions.
- Writing Process Transfer Plans Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Plans, which outline, in detail, the strategies, activities, and timeline for transferring a process between different facilities, as well as provide expected results and specifications for the transfer. The procedure also includes appropriate example tables to provide further guidance on creating the document.
- Writing Process Transfer Reports Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Reports, which provide documented proof that a transferred process performs at the receiver's facility and in the receiver's hands acceptably and comparably with the sender. The report summarizes the results of bench-top verification experiments, process scale-up, and optimization, as well as the Engineering Run at scale.
