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Table 1 Technology transfer documentation

From: Technology transfer and scale down model development strategy for biotherapeutics produced in mammalian cells

Document

Content

Bill of materials

List of all components and their step of use (Supplier, grade)

Research and Development reports

Historical data of pharmaceutical development of new drug substances and drug products at stage from early development to final application of approval - Quality profiles of manufacturing batches (including stability data) - Specifications and test methods of drug substances, intermediates, drug products, raw materials and components, and their rationale - Change histories of important processes and control parameters

Risk assessment

Process flow charts - Scale up - Equipment changes - Media and feed preparation

Process descriptions

Product information - Process step flow diagram - Cell culture steps description (cell line/ inoculum/expansion/production bioreactor - Media and feed preparation - Harvest description - Raw materials/equipment)

Technology transfer file

Introduction - Manufacturing process description, process parameters - Equipment - Raw materials - Analyses - Safety, environment - Stability (conditions, results) - Packaging (cold chain requirements, etc...) - Cleaning - Shipment characteristics and proper validation if needed - Historical data available

Technology transfer protocol

Technology transfer description - Scope - Objective - Responsibilities - Process Description - Equipment list (receiving unit) - Raw material list - Reference of Master batch record/number of repetitions and status of batches/acceptance criteria/relevant specifications/description of coaching

Manufacturing and testing description of the process

Product information - Process step flow diagram - Cell culture steps description (cell line/inoculum/cell expansion/production bioreactor) - Media and feed preparation - Harvest description (holding time/storage conditions) - Raw materials - Equipments

Routine and non-sampling plans

List of all the samplings that should be taken and kept in addition to the in-process control samples listed in the manufacturing description

Data recording list

Online and offline data to be monitored and recorded during the process

Deviation inventory

Description in details of the deviations and reporting of the impact on the product titer and quality

Technology transfer report

Technology transfer description - Objective - Scope - List of deviations and discussion - Process results and comparison to acceptance criteria -, Conclusions