Application Note - Single-Use Sensors in Thermo Fisher Scientific Bioreactors for CDMO Development

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Seamless Integration For Reliable Process Monitoring

Ensuring precise process control is essential in biopharmaceutical manufacturing, where even slight variations in pH and dissolved oxygen (DO) can impact cell viability, productivity, and product quality. Traditional reusable sensors require frequent calibration and sterilization, increasing operational complexity, contamination risks, and variability between batches. Patheon by Thermo Fisher Scientific, a leading contract development and manufacturing organization (CDMO), integrates Hamilton single-use sensors, including OneFerm™ pH and VisiFerm™ DO sensors, directly into its single-use bioreactors to enhance process reliability and efficiency. These sensors eliminate the need for on-site calibration, simplify workflows, and provide real-time monitoring to support consistent, high-quality biologics production.

Patheon Single Use Bioreactor Controller
Figure 1: Thermo Fisher HyPerforma SU Bioreactor.

Advantages of Hamilton Single-Use Sensors

Hamilton’s single-use sensor technology is designed to improve efficiency and reliability in biopharmaceutical manufacturing by offering:

  • Pre-calibrated functionality: Eliminates on-site calibration and reduces setup time and labor costs.
  • Sterility assurance: Gamma-irradiated and ready for immediate use, minimizing contamination risks.
  • Enhanced data accuracy: Provides reliable real-time measurements of pH and DO to optimize cell culture conditions.
  • Process scalability: Supports both small-scale development and large-scale commercial production.
Patheon Single Use Controller
Figure 2: Process Control System

Proven Performance in Biopharmaceutical Applications

Hamilton single-use sensors deliver precise, real-time monitoring of critical process parameters, helping to ensure stability, efficiency, and reproducibility in cell culture operations. Their integration into single-use bioreactors supports reliable process control from development to commercial-scale manufacturing. 

pH Stability

Precise pH control is critical for maintaining optimal cell growth and productivity. The Hamilton OneFermpH sensor demonstrated high accuracy within ±0.05 pH units across various operating conditions. Pre-calibrated at the factory, these sensors reduce batch-to-batch variability and eliminate the need for restandardization, ensuring greater process consistency in single-use bioreactors.

Dissolved Oxygen Response  

Dissolved oxygen is a key parameter in cell culture, influencing metabolism, viability, and product yield. The Hamilton VisiFerm DO sensor exhibited faster response times compared to traditional probes, allowing real-time process adjustments and improved control over oxygenation. This rapid feedback helps maintain optimal growth conditions throughout the bioreactor run, supporting the high standards of process control required in Patheon’s CDMO services.

Sensor Durability and Reliability

Reliable sensor performance over extended culture durations is essential for process stability. Hamilton single-use sensors demonstrated consistent accuracy without drift, maintaining precision across multiple production cycles. Their robust design ensures data integrity from inoculation to harvest, supporting regulatory compliance and high-quality biologics manufacturing at Patheon.

Enabling Efficiency and Quality in Biologics Manufacturing

Hamilton single-use sensors provide a robust and scalable solution for biopharmaceutical manufacturing. Their pre-calibrated design, sterility assurance, and real-time monitoring capabilities simplify bioprocess workflows while improving reproducibility and efficiency. Integrated into Thermo Fisher Scientific’s single-use bioreactors, these sensors enhance process control, minimize contamination risks, and streamline biologics production from early development to commercial scale.

Patheon Single Use Sensor
Figure 3: Hamilton single-use sensor in the Thermo bag.

Authors:

• Martijn Gelling, Process Engineer III, Thermo Fisher Scientific, Pharma Services
• Fazlan Rahim, MSAT Manager, Thermo Fisher Scientific, Pharma Services

Patheon Groningen (Netherlands), a part of Thermo Fisher Scientific.

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