Process monitoring being crucial for quality control in biomanufacturing, the FDA has presented Process Analytical Technology (PAT) and Quality-by-Design (QbD) principles, which ensure consistent product quality through continuous process monitoring. PAT is vital for the verification and approval of drugs, especially to reduce batch-to-batch variation and to ensure the management of critical process parameters (CPPs) for meeting the critical quality attributes (CQAs). This can be reached via continuous, real-time measurements throughout the biomanufacturing process rather than conducting manual quality testing which can be laborious, time-consuming, and produce delayed data. To comply with FDA regulations and ensure product safety and quality, Timegate is achieving GMP compliance this year to meet customer needs better.
Infrared, near-infrared, and Raman spectroscopy tools have been widely used in biomanufacturing as these spectroscopic tools can provide information on various analytes simultaneously and non-destructively. These tools allow for precise measurement of targeted substance concentrations in the bioreactor, ensuring consistent drug product levels, which makes them ideal for PAT applications in bioprocessing.
However, integrating new PAT tools into biomanufacturing processes can be perceived as challenging due to concerns related to technical compatibility, data integration and interpretation, regulatory issues, process adaptation, cultural resistance due to unfamiliarity with new methods, and continuous calibration needs to adjust and validate measurement and control instruments. This blog discusses how Timegate® Solutions addresses these concerns and transforms this landscape by offering smooth integration into bioreactors.
PicoRaman M3 spectrometer connected to a bioreactor via the ProbePro Mini sensor.
The PicoRaman M3 is a compact, user-friendly Raman spectrometer that fits seamlessly onto a laboratory table and is easily transportable to various sample collection sites. Its design allows for straightforward and autoclavable integration with the process environment, eliminating the need for extensive sample preparation and resulting in rapid setup times.
The ProbePro Mini add-on sensor enhances the integration by providing a simple process interface solution for measurements. It is designed to connect time-gated Raman spectrometers to bioreactors for in-situ, real-time analysis, enabling continuous monitoring of key process parameters via an optical interface. The ProbePro Mini is compatible with standard bioreactor port diameters and flange sizes facilitating easy installation. Its hermetic design and use of approved, sterilizable materials ensure a contamination-free environment, supporting sterilization processes including autoclaving, steam-in-place (SIP), and cleaning-in-place (CIP).
Further, Timegate experts provide a detailed manual and personal set-up assistance to ensure the smooth integration of Timegate® tools. To support bioprocess operators in adopting Timegated® Technology, we’re happy to offer additional training where needed. Timegate® tools accurately monitor CPPs, allowing operators to confidently adjust bioreactor feeds and maintain CPPs within limits, ensuring stress-free bioprocess runs. When it comes to continuous calibration, the Timegate system has a mechanism to alert the operator if there are any issues with the measurements or the device to help with the validation process. Data integration and interpretation are supported via Timegate’s flexible software solutions, which have been developed in co-creation with our customers based on their feedback.
Once integrated, the PicoRaman M3 and ProbePro Mini system enables immediate in-situ measurements. This setup allows for real-time, online monitoring of chemical changes within the bioreactor with high accuracy. The system's robust optical design ensures efficient, reliable, and user-friendly operation, providing highly specific chemical information and concentration quantification without the need for sample extraction or preparation, minimizing contamination risks. We work diligently with our customers and offer customization where needed to ensure a seamless start of in-situ measurements and bioprocess optimization. Since the Timegate System reduces the need for manual work and results in better productivity and yield, the return on investment (ROI) can be reached even within the first weeks of the bioprocess.
By facilitating rapid integration and a smooth start of in-situ measurements, the Timegate system streamline bioprocesses in several ways:
In summary, the integration of Timegate's PicoRaman M3 spectrometer and ProbePro Mini add-on into biomanufacturing environments offers an efficient solution for real-time, in-situ monitoring. This advancement not only simplifies the integration of new PAT tools but also significantly enhances the efficiency and control of bioprocesses.
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For a visual demonstration of the PicoRaman M3 spectrometer and ProbePro Mini in action, watch our videos here.