Application
Gene and Cell Therapy
In cell therapy, modified or cultured cells, either autologous (from the patient) or allogeneic (from a donor), are administered to the patient for therapeutic purposes. Gene therapy, on the other hand, works by altering genes either inside or outside the body.
Some therapies combine both approaches, using genetically reprogrammed cells designed to recognize and attack cancer cells efficiently. Whether using engineered or primary cells, large-scale manufacturing and expansion are crucial for producing high-yield cell doses sufficient for therapeutic effectiveness.
As Gene and Cell Therapy (GCT) manufacturing scales, maintaining rigorous quality control is essential. Testing methods such as endotoxin detection and infectivity monitoring support both safety and efficacy.
Closed-system workflows, designed to meet U.S. Food and Drug Administration (FDA) and European Union (EU) requirements, provide real-time monitoring of stem cells and other therapeutic cells while reducing contamination risks. These measures are important for meeting regulatory standards and ensuring the safe and reliable production of GCTs for clinical use.
How Hamilton Supports your Gene and Cell Therapy Workflows
GCT Process
This phase is common to both gene and cell therapy. It begins with thawing cells from a cell bank and expanding them through cell culture in flasks or bioreactors. The goal is to generate enough cells for the next steps. In cell therapy, these may be patient-derived cells (autologous) or donor-derived (allogeneic).
In Gene Therapy:
The expanded cells are transfected with plasmids encoding the therapeutic gene along with the necessary packaging components.
In Cell Therapy:
Instead of producing viral vectors, the cells themselves are the therapy. Here, genetic modification (e.g., via viral or non-viral methods) may be applied directly to the patient or donor cells, followed by further cell activation, expansion, and differentiation depending on the therapeutic goal (e.g., CAR-T cells, stem cells). There is no vector harvest; the focus is on maintaining cell quality and function.
In Gene Therapy:
The viral vectors are purified and concentrated using chromatography and filtration to remove cell debris, DNA, and host cell proteins before being filled into vials.
In Cell Therapy:
Since the cells are the final product, the focus is on cell washing, removal of residual reagents, and formulation in suitable media. The final steps include formulation, cryopreservation (if applicable), and sterile filling, ensuring the viability and potency of the product.
Hamilton’s automation solutions and sensor technologies are designed to meet the evolving demands of GCT workflows. With pioneering technologies and scalable solutions, Hamilton enables end-to-end automation for critical steps such as cell transfection, transduction, expansion, short-term cryopreservation, and the monitoring of Critical Process Parameters (CPP) during commercial manufacturing (see Bioprocess Upstream and Downstream Applications).
Hamilton’s robotic systems can further automate key analytical techniques used in development and Quality Control (QC), such as Enzyme-Linked Immunosorbent Assay (ELISA), quantitative Polymerase Chain Reaction (qPCR), and Liquid Chromatography–Mass Spectrometry (LC-MS) (see Analytical Development and QC application)
Explore our Gene and Cell Therapy Solutions and Applications in Detail
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Ambient, +4°C, -20°C Sample Storage
Verso Q-Series
Verso Q-Series automated freezer storage systems allow you to spend less time managing your samples. Verso Q20, Verso Q50, and Verso Q75 automated ambient to minus 20°C freezers feature large storage capacities in extremely compact footprints.
Ambient, +4°C, -20°C Sample Storage
Verso
Hamilton Verso is a modular compound management system for automated storage at temperatures from ambient to minus 20°C for high-throughput applications. This compound and sample storage system can easily be configured to meet your needs.
-80°C Sample Storage
SAM HD Pro
The SAM HD Pro lab freezer is your solution for high-density storage with a small footprint. This compact lab freezer is capable of ultra-low temperatures down to minus 80°C to ensure sample integrity. The SAM HD Pro sample freezer makes automated storage quick and easy.
-80°C Sample Storage
BiOS
BiOS is Hamilton’s premier minus 80°C freezer for medium- and large-capacity storage. This ultra-low temperature freezer maintains the integrity of your biological sample storage throughout automation. With customizable size and capacity, this minus 80°C freezer can be scaled to fit your storage needs.
Capping & Decapping
LabElite DeCapper
The LabElite DeCapper by Hamilton automates tube capping and decapping, improving efficiency and sample integrity.
Capping & Decapping
LabElite Handheld DeCapper
The LabElite Handheld DeCapper is a semi-automated device designed for efficient capping and decapping of tubes in 48- and 96-format racks.
Barcode Reading
LabElite I.D. Reader
The LabElite I.D. Reader by Hamilton automates barcode scanning for 2D-labeled tubes.
Capping & Decapping
LabElite I.D. Capper
The LabElite I.D. Capper from Hamilton combines automated tube capping/decapping with high-speed barcode reading in one device.
Capping & Decapping
LabElite DeCapper SL
The LabElite DeCapper SL by Hamilton automates tube capping and decapping for 24-, 48-, and 96-format racks.
The Hamilton Microlab Prep is an affordable liquid handler perfect for automating workflows. This entry-level liquid handler supports automated PCR setup and serial dilution.
The Hamilton Microlab STAR is a reliable and versatile automated liquid handling platform. With advanced features like multi-probe heads, pipetting technologies, and VENUS software, this premier liquid handling system fits your laboratory needs. Revolutionize your workflows with the STAR today!
Hamilton STAR V, a cutting-edge liquid handling robot, unites Microlab STAR flexibility with Microlab VANTAGE high-performance capabilities to boost efficiency. The Microlab STAR V offers speed, precision, and technology for automated liquid handling. Upgrade your lab—explore the Microlab STAR V!
Hamilton VANTAGE 2.0 is a cutting-edge liquid handling system with automated precision. Optimize workflows with the VANTAGE robot, all while boosting performance, safeguarding samples, and maximizing walk-away time. Discover the Hamilton VANTAGE liquid handler for your current & future needs.
Assay Ready Workstations
NGS STARlet
Compact and efficient, the entry-level NGS STARlet from Hamilton includes all the devices you need to automate sequencing library preparation of up to 24 samples at once with detailed precision, accuracy, and reliability.
Assay Ready Workstations
NGS STAR Line
Hamilton NGS STAR helps streamline next-generation sequencing in labs. Achieve full NGS automation for library prep, optimized for NGS assays and genome sequencing. Enhance efficiency, precision, and reliability in your workflows. Explore the Hamilton NGS STAR for seamless sequencing today!
Assay Ready Workstations
NGS STAR V
Automate NGS library preparation with the Hamilton NGS STAR V Assay Ready Workstation—optimized for demanding high-throughput genomic research.
Lab Syringes
Microliter Syringes
Hamilton Microliter syringes are ideal for dispensing homogeneous liquid samples not prone to glass bonding or precipitation. With a hand-fitted stainless steel plunger for frictionless movement and minimal wear, these syringes are designed to last.
Lab Syringes
Gastight Syringes
The solution for dispensing both gases and heterogeneous liquids. Hamilton Gastight syringes are equipped with a precision-machined PTFE plunger tip to create a leak-free seal.
Good to know about Gene and Cell Therapy workflows
This section provides a selection of additional resources related to the application described on this page. It includes helpful articles, videos, and blogs that offer deeper insights into the topic.
Useful Links
External resources not written by Hamilton but valuable for understanding the topic, such as industry guidelines, explanatory videos, or relevant tools.
| Cell Therapy Manufacturing Explained- Takeda | Watch Video |
| Melocchi, A., Schmittlein, B., Sadhu, S., Nayak, S., Lares, A., Uboldi, M., Zema, L., Nicolis di Robilant, B., Feldman, S. A., & Esensten, J. H. (2025). Automated manufacturing of cell therapies. Journal of Controlled Release, 381, 113561. | Read Article |
| Wang, B., Bowles, A. C., Yeago, C., & Roy, K. (2021). Process analytical technologies in cell therapy manufacturing: State‑of‑the‑art and future directions. Journal of Advanced Manufacturing and Processing. | Read Article |
| Moutsatsou, P., Ochs, J., Schmitt, R. H., Hewitt, C. J., & Hanga, M. P. (2019). Automation in cell and gene therapy manufacturing: From past to future. Biotechnology Letters, 41(8), 1245–1253. | Read Article |
Hamilton Products in Action
A collection of videos showcasing Hamilton products in use, providing practical insights into their functionality and benefits.
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Solutions for Top 3 Challenges of the Gene and Cell Therapy Workflows
Process Standardization and Scalability
Challenge: GCT workflows are frequently developed through manual methods in research labs, which can lead to high variability and inconsistent standards. These issues make it challenging to scale processes for GMP manufacturing, complicate quality control, and raise the risk of regulatory non-compliance.
Solution: Hamilton’s automated solutions standardize and optimize laboratory workflows to improve efficiency and accuracy. These systems ensure precise pipetting, sample traceability, and highly reproducible results. Many of these solutions are successfully implemented in Good Manufacturing Practice (GMP) environments. In addition, Hamilton offers fully automated, ready-to-use systems for established workflows, including cell culture, genetic engineering, and Next-Generation Sequencing (NGS).
Cell Viability and Product Consistency
Challenge: The success of GCT products depends heavily on the health, purity, and function of living cells throughout the manufacturing process. Maintaining cell viability and functional characteristics is important whether you are engineering T-cells in CAR-T therapy or expanding stem cells for regenerative applications. However, cells are highly sensitive to environmental changes, mechanical stress, and inconsistent handling.
Solution: Hamilton supports cell viability and process consistency with automated solutions like the Cell Care STAR, which standardizes cell culture workflows to reduce variability and handling stress. When paired with Hamilton’s controlled storage systems, which maintain precise humidity and temperature, they help preserve cell integrity, enhance reproducibility, and support compliant, high-quality manufacturing.
Real-Time Process Control and Regulatory Compliance
Challenge: GCT workflows can be unpredictable and require close control, with little room for error during steps such as cell expansion, transduction, and purification. The FDA’s Process Analytical Technology (PAT) framework stresses the value of real-time monitoring and control to maintain quality and prevent batch failures. Despite this, many GCT processes still depend on offline testing and manual checks, which reduce visibility into critical process parameters (CPPs) and slow corrective responses. These gaps can delay development, increase risk, and complicate regulatory submissions..
Solution: Hamilton enables PAT-driven manufacturing with intelligent, in-line sensor technologies designed to deliver real-time data on key metrics such as pH, dissolved oxygen, and conductivity. These digital sensors integrate seamlessly with automated platforms and data systems to support continuous monitoring, immediate deviation detection, and robust documentation. By embedding PAT principles into the GCT workflow, Hamilton empowers manufacturers to optimize yield, enhance product consistency, and meet regulatory expectations with greater efficiency and confidence.
What is the Use of Gene and Cell Therapy?
GCTs are revolutionary biomedical approaches used to treat or prevent diseases by directly targeting the underlying causes at the genetic or cellular level. Specifically, gene therapy involves modifying or replacing faulty single genes responsible for inherited disorders, while cell therapy often focuses on manipulating stem cells or blood cells to restore or enhance normal biological function. These therapies are particularly valuable in addressing complex conditions such as genetic diseases and cancers, where early, targeted intervention can occur even before symptom onset, potentially improving patient outcomes and altering disease progression.
What is an example of Gene and Cell Therapy?
An exemplary application of GCT is Chimeric Antigen Receptor T-cell therapy, commonly known as CAR-T therapy. This innovative treatment harnesses the patient’s own blood cells, specifically T-cells, which are collected and genetically modified using engineered vectors. These vectors introduce a synthetic receptor that redirects the T-cells to recognize and attack cancer cells, offering a highly targeted and personalized approach to treating certain hematologic malignancies such as leukemia and lymphoma.
The CAR-T manufacturing process exemplifies the complexities and rigor involved in modern cell therapy manufacturing. The entire procedure is conducted within a closed system to minimize contamination risk and preserve the integrity of the precious cellular product. This closed-system approach ensures aseptic handling from cell collection, genetic modification, expansion, to the final formulation before reinfusion into the patient.
What Measures Ensure the Safety and Effectiveness of Gene and Cell Therapies?
The success of GCT relies heavily on sophisticated delivery systems, mainly vectors, which carry therapeutic genetic material into the patient’s cells. Ensuring the safety and effectiveness of these therapies requires rigorous quality control and comprehensive testing methods.
Key steps include endotoxin testing to detect bacterial toxins that may trigger immune reactions, and infectivity assays that check for replication-competent viruses or other contaminants. These testing protocols are crucial to the manufacturing process and the release of the final product, ensuring that every therapy meets the highest standards of safety.
All GCT products must comply with FDA- and European Medicines Agency (EMA)- approved regulations, ensuring consistent quality and patient safety throughout development and clinical use. Most therapies undergo extensive evaluation in clinical trials, where validated testing methods monitor their efficacy, safety, and reproducibility in real-world patient populations.
The integration of these robust quality control measures with precise vector design and cell manipulation techniques underscores the growing confidence in gene and cell therapies as viable treatment options.
Gene and Cell Therapy Case Studies and Application Notes
Other Gene and Cell Therapy Resources
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
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