Cell Therapy

Robust Cell Therapy Manufacturing

Enhance process understanding, optimize process performance, and ensure batch-to-batch reproducibility in cell therapy manufacturing with easy-to-use PAT tools.

Overcoming Manufacturing Challenges in Cell Therapy

Cell therapy is increasingly becoming a viable therapeutic alternative to traditional treatments for a wide range of diseases. However, the complexities of manufacturing process characterization and control severely limit their availability and wide adoption. Dealing with the variability of starting materials, meeting strict manufacturing timeframes, and maintaining compliance with Current Good Manufacturing Practices (cGMP) make it difficult to develop and implement a robust manufacturing process. Transitioning away from manual manufacturing protocols and towards adaptive process strategies requires careful monitoring and control of critical process parameters (CPPs) with the help of at-line, on-line, and in-line Process Analytical Technologies (PAT).

Rapid at-line media analysis with REBEL
Direct control of auxiliary pumps with MAVEN and MAVERICK
Real-time monitoring of multiple CPPs with MAVEN and MAVERICK

Amino acids are critical to cellular function and viability, but different cells may consume them at different rates.  Monitoring concentrations of amino acids during cell expansion helps prevent their depletion that may cause a batch failure.

Real-time Glucose Monitoring

Glucose is the primary energy source and its concentration in the media regulates metabolic pathways and is linked to proliferation, metabolites production, and phenotype expression. Continuous glucose measurement can be used for control of substrate feeding or media exchange pumps. 

Continuous Lactate Monitoring

Excessive accumulation of lactate can inhibit cell growth and decrease cytokine secretion. It can also be used to estimate cell count, predict cell expansion rate, determine optimal harvest time.

In-line Biomass Measurement

In-situ Total Cell Density (TCD) measurement can be used to ensure that appropriate cell densities are achieved, especially in adherent cell cultures where cell counting is difficult to perform. 

Media Fingerprinting & Screening

Screen and compare commercially available cell therapy media and ensure consistency of media formulations from run to run. With REBEL, you get at-line media analysis of 30+ components in under 10 minutes.

Accelerate Media Optimization

Developing and optimizing media formulation necessitates careful monitoring of key nutrients’ consumption, metabolite production and their collective effects on process efficiency and product quality attributes. Waiting weeks for cell culture media analysis results is not feasible. REBEL provides a solution with its rapid analysis turnaround time, small sample volumes, and minimal sample prep.  

Real-time Monitoring Can Make a Big Impact on Your Process

Ensure Process Robustness with Real-Time Monitoring

A well-characterized and controlled production process is crucial for effectiveness of cell therapy and necessitates integration of Process Analytical Technology (PAT) solutions with automated cell therapy manufacturing systems. MAVEN and MAVERICK easily integrate with cell therapy manufacturing systems and deliver continuous monitoring and control of critical process parameters (CPPs) such as glucose, lactate and total biomass, enhancing process understanding, ensuring robustness and reducing human intervention. With REBEL amino acids concentrations in the media can be frequently monitored during cell expansion processes to ensure that any variations in cell growth and health were not due to unknown changes in expected media formulation.

Timely Process Insights in Cell Therapy Manufacturing

Our suite of devices provides at-line, on-line or in-line monitoring for cell expansion process.

Implement Process Analytical Technology (PAT) in Your Cell Therapy Workflows

Historically, automated cell therapy manufacturing systems had limited real-time monitoring capabilities due to lack of robust and compatible process analytical technologies. MAVEN and MAVERICK are offered with a variety of single-use and reusable process interfaces and multiple analog and digital communication options making integration possible with a number of manufacturing automation systems.

Reusable and single-use immersion probes and flow cells
Analog (mA or V), Serial, Modbus TCP and OPC UA
Reusable optical immersion probe
Analog (mA or V) and OPC UA

For Cell Culture Media Analysis

REBEL

Analyze fresh or spent media and get quantitative reports for amino acids, dipeptides, water soluble vitamins and biogenic amines.

For Glucose & Lactate

MAVEN

Get valuable insights and control from real-time glucose and lactate monitoring without the loss of bioreactor or fermenter volume.

For Bioprocessing

MAVERICK

Raman-based, in-line monitoring and control of multiple bioprocessing key process parameters in up to six bioreactors simultaneously.

908 Devices and Terumo BCT Announce Collaboration

908 Devices and Terumo Blood and Cell Technologies collaborate to add on-line analytics to Quantum Flex cell therapy expansion systems.

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