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The quality attributes of advanced therapy medicinal products (ATMPs) that correlate with safety and efficacy in patients are determined not only by manufacturing process inputs such as starting and raw materials, but also by how the manufacturing process itself is designed and controlled. To ensure regulatory compliance, the manufacturing process should therefore be developed based on thorough characterization of the ATMP during all stages of process and analytical development; this ensures that the critical quality attributes that correlate with safety and efficacy are identified and that their specifications can be met during routine manufacturing. This session will include presentations exemplifying design, manufacturing and operation of the commercial manufacturing of medicinal products.
Speaker(s):
Richard
Denk,
Senior Consultant Aseptic Processing & Containment,
SKAN AG
Robert
Dream,
PE, CPIP, PhD,
Managing Director,
HDR COMPANY LLC