How A LIMS Increases Efficiency for Cellular Therapy Labs
Cellular-based therapies (CBT) represent the most advanced medical treatments on the market – and some of the most unique challenges facing labs.
For one, CBT is a fast-growing industry (estimated to grow 22% from 2023 - 2032) and incredibly labor-intensive.
Whether your lab uses immune cells, CAR-T cells, or stem cells, chances are good that you’re spending a fair amount of time worrying over the logistics of transporting cells into your lab, tracking them through their lifecycle, and ensuring your lab meets regulatory compliance standards.
You're already far behind if your lab still uses pen and paper to monitor samples and inventory. This article will walk through the most common challenges Cellular Therapy labs face and show how a LIMS can overcome them.
Which Types of Cellular-Based Therapies Can a LIMS Help With?
Cellular therapies involve using living cells for medical treatments, usually relying on the unique properties of cells to restore normal function, regenerate tissue, or modulate immune responses.
A LIMS can aid with a broad spectrum of CBT, including:
- CAR T-Cell Therapy: A LIMS can help manage the workflow from patient T-cell collection through gene modification, cell expansion, and final product release.
- Stem Cell Therapies: A LIMS can facilitate donor/patient matching while tracking the complete isolation, cryopreservation, and storage process.
- Natural Killer Cell Therapy: A LIMS oversees autologous and allogeneic cell sourcing, tracking expansion protocols, and activation processes.
- Tumor-Infiltrating Lymphocyte Therapy: A LIMS controls the workflow from tumor tissue processing through lymphocyte isolation and expansion while monitoring quality attributes and documenting final product specifications.
- Dendritic Cell Vaccines: A LIMS tracks the process from initial monocyte collection through differentiation and antigen loading while managing sterility testing and documenting all release criteria.
These therapies (and others like them) face numerous challenges, which we’ll explore next.
The Top 5 Challenges in Cellular Therapies
CBT carries the dual hope of personalized medicine and the ability to treat formerly untreatable conditions.
Realizing these hopes requires a simplified production process covering the entire workflow, from collection to transportation and manufacturing.
Despite the sophistication of their work, many labs rely heavily on paper-based systems, which leads to significant delays and mismanagement. This compounds the increasing challenges and leads to the following obstacles:
- Sample collection and management
- Transportation and process development
- Inventory and data management
- Traceability and integrity
- Quality Assurance
Sample Collection and Management
Manufacturing these groundbreaking cell-based therapies starts with collecting the patient’s cells. Unlike routine blood donations, collection must be precisely timed to maintain cell viability and ensure they are optimal for further processing.
Any delays or scheduling errors can be catastrophic – compromising the quality and viability of the collected samples and rendering them useless.
Because of these stakes, it is essential to accurately track each tissue sample's entire lifecycle from collection, storage, and processing to distribution. This need for meticulous (and timely) records breaks down quickly when done manually through spreadsheets or pen and paper.
Transportation and Process Development
Cells must be transported promptly and in adequate conditions to ensure they remain viable as they make their way from the patient to your lab. Once they arrive, these cells often undergo complex production processes. Insufficient documentation and tracking of the entire workflow can lead to errors and inconsistencies that slow development and compromise quality.
This is not just an issue when collecting cells. Poor cell process and maintenance management can lead to contamination, degradation, or misidentification, rendering the cells useless.
Inventory and Data Management
Inventory management is a core competency for any lab, especially CBT labs. Whether you are keeping track of cells or recording stock levels for other vital materials, running out of stock or missing expiration dates can cause severe setbacks and disruptions.
Data Traceability and Integrity
CBT labs generate vast amounts of data in the production, manufacturing, and validation of materials. Manually managing this data quickly becomes a nightmare fraught with data loss, errors, and numerous compliance issues.
Not to mention the fact that paper-based systems and spreadsheets lack proper data validation, access controls, or collaboration features to help your lab scale as your staff increases. One misentered data point or lost record can lead to regulatory compliance issues and slowdowns.
Quality Assurance
As discussed above, labs trying to manage quality assurance (QA) and quality checks (QC) manually or with spreadsheets face difficulties as their team expands.
Manual systems lack the proper QA/QC features your lab will need, whether it be managing samples, properly storing documents, or calibrating instruments. Trying to manage QA/QC manually can quickly become a monumental task, especially as your lab’s throughput increases.
What is a LIMS?
Manual methods of recording samples, inventory, and other vital data fall short for CBT labs.
That’s where software like a LIMS can be especially useful. A LIMS (Laboratory Information Management System) is a comprehensive software platform that simplifies increasingly complex lab work.
Lab staff and technicians use LIMS in various settings, including agriculture, food, environmental, manufacturing, diagnostic, and materials labs. Anytime regulations, data complexity, and sample volume are concerns, a LIMS can help. But necessary functions vary by lab.
A LIMS can help your lab with:
- Data management
- Test result management
- Sample management and traceability
- Inventory management
- Regulatory compliance
Read on as we explore the critical functions of a LIMS in depth.
How a LIMS Can Help Your Cell Therapy Lab
Cell therapy labs face numerous manufacturing, scheduling, logistics, and compliance challenges.
Fortunately, a LIMS excels at overcoming these obstacles and more with ease. Through data centralization, real-time sample tracking, and automation, a LIMS can streamline your lab’s workflows and improve overall efficiency and traceability.
Below are some of the notable features of a LIMS like QBench that address the challenges faced in the cell therapeutics industry:
- Sample management
- Data management and centralization
- Regulatory compliance support
- QA/QC support
- Collaboration and scalability
A LIMS Aids Sample Collection from the Patient
A LIMS can help your lab coordinate and monitor samples from the moment they are collected in your lab. Through automatic data capture and sample tracing through each stage, your lab can have a real-time read on where samples are.
QBench offers robust sample management features to help you track each sample at every stage in the manufacturing process. This ensures that no samples are lost or wasted and that each therapy arrives on time and in perfect condition.
A LIMS Supports Data Management and Integration
To say that a LIMS allows you to digitize your lab’s data is almost a gross understatement. Yes, a LIMS serves as a central repository of information, but how it retrieves that information sets it apart. A LIMS collects information via:
- Automatic data capture
- Integration with lab instruments
- Integration with other software platforms
It provides real-time insights into every aspect of your lab, ensuring seamless integration with all of your systems and easy retrieval of critical information.
QBench integrates with numerous lab instruments, offers a robust RESTful API, and connects to 50+ popular software platforms.
A LIMS Helps With Regulatory Compliance
Not only does a LIMS serve as a digital system of record for your lab’s data, but it can also aid in meeting regulatory compliance standards through various security features, including user access controls, access logs, and more.
A good LIMS will offer role-based access to dictate who can access datasets and regularly back up and restore data in case of a breach or downtime. QBench takes security seriously, ensuring your data is encrypted, backed up, and accessible whenever needed.
A LIMS Facilitates Collaboration
Cloud-based software like QBench vastly improves collaboration between diverse teams, advancing cellular therapy and enabling researchers, doctors, and regulatory experts to securely access and share data worldwide.
As the demands of cell therapy lab research grow, cloud-based software offers seamless scalability, eliminating the need to manually incorporate new features and updates since they are automatically integrated. This accommodates increased data volumes and more complex processes.
A LIMS Aids With Quality Control
A good LIMS will empower your lab by helping you monitor quality control, alerting you of errors or risks, and facilitating corrective and preventative actions where necessary.
QBench comes with a built-in QMS to help you:
- Track quality records
- Track instrument calibration and maintenance records
- Create and update standard operating procedures
- Create and update training materials
- Store all lab documentation
This not only helps you meet certain regulatory requirements but also streamlines your lab and prevents slowdowns. You can quickly detect deviations and ensure consistent product quality by monitoring essential factors such as cell viability, purity, and potency.
Which LIMS is the Best Option for Cell-Based Therapy Labs?
Which of all the LIMS on the market today will you choose?
We’ve ranked and compared the best LIMS available and would recommend QBench as the clear winner.
According to G2’s Top LIMS Rankings, QBench is voted the best LIMS overall. QBench is flexible enough to adapt to your unique workflows and automate your cell therapeutics lab to eliminate laborious manual processes and outdated, cumbersome systems.
QBench also ranks higher than the category average for ease of use, ease of setup, ease of doing business, quality of support, and ease of admin.
When you choose QBench, you're not just choosing a LIMS but a partnership that will grow with your lab.
Ready to Use a LIMS in Your Lab? Download Our Free LIMS Buyer’s Guide
If you’re ready to move beyond the manual grind of spreadsheets and select a LIMS to streamline inventory management, sample management, and manual processes for your lab, then download our free LIMS Buyer’s Guide to help you choose the right LIMS for your lab.
Click the button below to download the free buyer’s guide and take the first step toward improving your lab’s inventory management processes.
