Fixing the Reproducibility Problem: Why Laboratories Need Traceability of Data and Processes
Introduction: The Irreproducibility Problem with Lab Data
Cell culture labs today are struggling to handle intricate data streams produced from increasingly complex experimentation. The result: lab results that cannot be reproduced successfully.
As illustrated in a study by the Global Biological Standards Institute, fully half of the U.S. annual preclinical research spend is not reproducible – the largest share of that irreproducibility stems from material variability as well as cell culture contamination and drift.
Beyond that, misidentified or contaminated cell lines also contribute to the irreproducibility problem, which is continually growing in severity. With complete and accurate tracing of cell lineage, lab data, and lab processes, cell culture labs have the opportunity to address all of these issues outright.
As labs scale, outsource to third parties, or shift towards digital workspaces, data and process traceability and cell lineage capabilities ensure high standards of accuracy and reliability that are prerequisites for reproducible cell culture operations.
Let’s dive into how cell culture labs can achieve full traceability of data and cell lineage through the digital transformation of lab processes.
Improving Cell Culture Reproducibility with Data
In the biotechnology and cellular research space, cell culture stands as one of the foundational techniques across drug development, cell therapy, gene therapy, and even tissue engineering. But with great potential comes great responsibility, especially when handling and managing the vast data involved.
The amount of data generated isn't solely a byproduct of lab activities; in fact, it has the potential to become an invaluable asset. Whether it’s hypothesis testing, batch record reports, or publication of research finding publication, data leads to better decision-making and improved reproducibility.
Why is Cell Culture Data Management Important?
Cell culture is a highly nuanced process. With every cell sample, incubation period, and protocol, even a minor deviation can drastically alter cell culture outcomes. One study published on the culture processes for monoclonal antibody production shows that a deviation of just 0.1 units from the optimal pH can significantly impact cell culture growth and metabolism.
In the competitive pharmaceutical market, the transparency and validity of data makes all the difference in gaining the trust of stakeholders, partners, and consumers. Precise data management also reduces risks across the board, whether financial, medical, or ethical.
With comprehensive data management, researchers can track every detail of the cell culture process all along the ancestry of cells – this is known as cell lineage, and next we’ll discuss why cell lineage is vital to sustainable lab operations.
The Difference Between Cell Lineage and Data Traceability
While similar, cell lineage and data traceability focus on different objectives for the lab. Cell lineage tracks the journey of the cells from their origin to their current form, analyzing how the cells behave over time.
Conversely, the aim of data traceability is to document the data’s lifecycle for auditing purposes, tracking not only who added or changed each datapoint and associated metadata along with the precise date and time that the datapoint was added or changed (the ‘what’, ‘who’, and ‘when’), but also the protocol that was being followed to collect the datapoint in the first place (the ‘how’ and the “why’).
The Benefits of Cell Lineage in Cell Culture
Through every passage, from its origin to its current state, tracing cell lineage offers a complete history of the life journey of cells.
Cell lineage maps the entire ancestry of cells, including the entire ecosystem of media and other materials, incubators and other equipment, and all the protocols and people who have touched the cells from one generation to the next.
With the aim of improving reproducibility, keeping real-time cell lineage data helps labs to:
- Highlight anomalies or deviations
- Ensure consistency and purity of cell lines
- Identify root cause of any material changes
- Give researchers roadmap for cell culture operations, like stem cell research or genetic modifications
As biopharma and other cellular research sectors become more advanced, having a detailed understanding of each cell's history becomes imperative. Simple changes may lead to significant setbacks in research, making accurate cell lineage tracing a cornerstone of success.
So how can a lab ensure full cell lineage and data traceability capabilities in their operations?
Navigating the World of Lab Data Management Tools
As laboratories evolve and embrace modern technologies, a suite of tools has emerged, with each tool each designed to optimize specific aspects of data management. Understanding these tools and their distinct functionalities is pivotal to maximizing lab efficiency.
How Does an Electronic Lab Notebook (ELN) Enhance Data Handling?
ELNs have revolutionized lab data recording. Gone are the days of paper laboratory notebooks. ELNs digitize notes, making them easily searchable, shareable, and less error prone. It’s not just about convenience; ELNs enhance data accuracy, reproducibility, and security, streamlining the entire research process. In a paper published in Nature, Higgins et al. reinforce that ELN systems can much more readily adapt to volume, complexity, accessibility, and preservation needs than conventional notebooks.
Why Are Lab Information Management Systems (LIMS) Essential?
Lab Information Management Systems integrate various lab operations into a cohesive system. From sample management to testing and reporting, a LIMS automates and centralizes important process-related data and metadata. This integration reduces manual entry errors, boosts productivity, and ensures that data are consistently managed and easily retrievable.
What Advantages Do Lab Execution Systems (LES) Offer for Lab Protocols?
LES provides a structured approach to lab workflows. According to best practices established by the International Society for Pharmaceutical Engineering (ISPE), traceability for individual containers is incredibly important to prevent mix-ups. By standardizing and automating protocols, an LES ensures that experiments follow a consistent process, reducing variability. This consistency ensures better data quality and experimental reproducibility, crucial in any scientific endeavor.
Why Is Batch Records Management Crucial for Labs?
Batch records document every detail of a production process. In manufacturing, meticulous batch record management ensures quality assurance, helping meet regulatory standards. By effectively managing these records, labs can trace back any issues, ensuring the quality and safety of their outputs.
Introducing CellPort: A Breakthrough in Lab Data Traceability
The increasingly rapid progression of research at the cellular level only highlights the increased need for easier and more precise data management for cell-related research and manufacturing. To fill those demands, labs are turning to software applications – like CellPort – with features specifically designed for cellular research environments.
What Can CellPort Offer to Laboratories?
CellPort provides a comprehensive, integrated approach to managing lab data. It is designed with an emphasis on ensuring data traceability, and more easily enables researchers to keep track of each cell's lineage and journey. By simplifying the process and offering tools tailored for cellular research and manufacturing, CellPort helps support the diverse needs of modern cellular laboratories.
Consider CellPort for Your Lab's Data Needs
Selecting the right data management system is vital in today's research landscape. Designed by scientists for scientists, CellPort has been developed with an understanding of the unique challenges faced in cell culturing, banking, and manufacturing.
With its user-friendly interface and industry-leading security protocols, CellPort is the preferred option for any lab looking to upscale their cell culture operations.