Automated Process Control of Pharmaceutical Lyophilization: PAT Enabled Freeze-Dryer

Develop and test a PAT enabled Freeze-Dryer, with automated process control based on critical product parameters.
Categories
Drug substance
Process control
Project status
100% Completed

Industry Need

Current pharmaceutical lyophilization methods have an extended process duration.

Solution

Develop a new process development and control software that accounts for intra- and inter-batch product drying heterogeneity.

Outputs/Deliverables

  • PAT-Enabled Freeze-Dryer User Requirements Specification (URS) Document.
  • Three versions (Gen-2, 3 & 4) of a SMART Freeze-Dryer process control algorithm capable of maintaining the product temperatures within ±2°C threshold, objective ±1°C of the target temperature.
  • Ability to use multiple PAT tools to monitor and control the lyophilization process, including MTM, TDLAS, PDT, TCs and capacitance manometer and Pirani pressure gauges. Accomplished for all PAT tools except for pressure drop technology (PDT) measurements.
  • Ability to use PAT tools to automatically transition from primary drying to secondary drying.

Impacts

The PAT Enabled Freeze-Dryer will use real-time measurements to automatically control lyophilization processes based on key product parameters (KPPs), such as the critical product temperature and target product temperature during primary drying.

Publications

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Project Lead

Physical Sciences Inc

Physical Sciences Inc

Participating Organizations

Genentech, Inc.

Genentech, Inc.

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

National Institute for Pharmaceutical Technology and Education, Inc (NIPTE)

National Institute for Pharmaceutical Technology and Education, Inc (NIPTE)

Pfizer, Inc.

Pfizer, Inc.

SP Scientific
University of Massachusetts Lowell

University of Massachusetts Lowell