Benefits of an ELN in BioPharma

With more and more pressure being put on research and development units to accelerate the drug development process, many organizations are changing the way they operate. Biopharmaceutical companies are collaborating with academia and CROs in the discovery process and looking at new technology to make their process more efficient. One such technology that, when implemented correctly, enables collaboration and improves process efficiency is the Electronic Lab Notebook (ELN).

An ELN is a multidisciplinary system that provides tools to design and capture experimental protocols, results, and research findings in electronic form. ELNs are designed for scientists in different areas of research such as chemistry, biology, analytical, in vivo, and clinical. Using an ELN:

• frees scientists from many of the time-consuming manual transcription or administrative tasks associated with paper file management;
• enhances intellectual property (IP) protection;
• eases experimental design;
• and provides interfaces to instrumentation and systems for much easier capturing, securing, retaining, searching, and reusing institutional knowledge.

Below, we’ll dive into each of those advantages and further explain how your laboratory can benefit from an ELN.

Paper Replacement

Research laboratories without an ELN are most likely using a variety of tools, most prominently Excel spreadsheets and a lot of paper to conduct their work. Pertinent experimental data is then collated and entered into a paper Lab Notebook. Implementing an ELN will help your laboratory begin the process of going paperless. ELNs are designed to replace paper notebooks through the use of electronic, smart and intuitive forms. This eliminates the need to copy and paste data, such as instrument printouts, into the paper lab notebooks. The benefits of a simple replacement of a paper lab notebook with an ELN include:

• Elimination of:
  • Transcription errors
  • Data loss
  • Haphazard record storage
  • Storage and archiving of paper notebooks and binders of QA/QC analysis documents including raw data
• Improved availability of experimental data
  • Rapid access to data held digitally rather than searching through paper lab notebooks
• Ease of use
  • Younger generations of scientists are more used to digital access than paper including tablets, smartphones, and other devices that can connect to ELNs

And just imagine, research notes without coffee stains, ripped sheets, or the fear of losing records by accident or in a fire!

Eligibility for Patent (IP) Purposes

A major concern of managers in R&D environments is to protect intellectual property. Those of you who have worked in a chemistry lab probably had a supervisor who was always asking you not to leave chemical structure diagrams hanging everywhere.

Through the use of ELNs, each experiment, including your chemical structure diagrams, can be digitally recorded and secured, Access can be granted on a need to know basis. In addition, entries in the ELN are time-stamped, changes logged, and e-signatures applied. The result is a complete audit trail of the entire experiment. Controls can be applied to experiment data to satisfy both legal and regulatory requirements such that the data can be used for patent submissions.     

Ease of Experimental Design

Configured correctly, an ELN can streamline the experimental process from experiment creation to experiment conclusion. ELNs offer the following capabilities:

• Creation of experiments
  • from a blank or configured template
  • through cloning of previous experiments
• Execution
  • Experiment execution through different instruments and equipment  
• Data collection
  • File import capabilities from external sources, e.g., plate reader, for calculation purposes
• Processing and calculations
  • Configuration of calculations, e.g., analytical and formulation calculations
• Assay/test workflow automation
  • Strategic design of experiment workflows and tools that enable standardization, consistency, and automation

Instrument Interfacing, Systems Integration, and More…

Interfacing your laboratory instruments and integrating other systems with your ELN can be accomplished in a number of ways. Most ELNs have built-in instrument interfacing capabilities and many ELNs have Application Programming Interfaces (APIs) that can be used to extend the capabilities of your ELN. These integration solutions work with:

• Instruments
  • pH meters, balances, calipers, HPLCs, and many other devices
    • Simple one-way interface of a lab instrument to the ELN via RS-232 or printer port
    • Simple one-way interface of a lab instrument to the ELN via file transfer
• Systems
  • Laboratory informatics systems – LIMS, LES, CDS, SDMS, etc.
  • Manufacturing systems – ERP, MES, PLM, MRPII, etc.
  • Inventory management system
  • Chemical and biological registration systems
  • Reporting, visualization, and statistical systems

Major benefits of instrument interfacing and system integration include:

• Increased productivity
• Improved data quality
• Rapid analysis and decision making

Work Locally and Share Globally

By combining research data from different internal or external groups in an ELN system, you make the information securely available and easily searchable across your organization (including external partners), speeding up your research findings and decision making Remember that in order to achieve rapid access to your data across the enterprise you must spend time upfront to standardize the use of the ELN.  For example, you must define naming conventions for such items as folder, experiment names, assays, metadata, etc.

The benefits you will achieve through designing the foundations of your ELN before you start implementing include:

• Intra and Inter collaborations with multidisciplinary capabilities
  • Chemistry, biology, analytical, in vivo, and clinical domains
• Sharing data with granular access permissions
• Coordinating efforts of different groups or projects
  • Shared projects
  • Shared notebooks
  • Shared experiments
• Data Visualization
  • Combination of data from various experiments no matter where they are performed.
• Reporting capabilities
  • Trend and statistical analysis reports across multiple research units
  • Daily, weekly, monthly, and quarterly reports
  • Conditional reports that may be required based upon a condition (e.g., pH is trending upwards)
  • Management and lab administrative reports

In summary, when implemented correctly, ELNs facilitate interoperability that fundamentally changes the ways scientists perform experiments and manage their data. ELNs eliminate communication issues, replication of work, and different interpretations or approaches (especially in an interdisciplinary setting). An ELN has the flexibility to adapt easily, to automate very complex workflows, and to support discovery research where IP protection, data processing and sharing, and reporting and visualization are important objectives.

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Have you implemented and ELN and realized the benefits outlined in this blog? If not, when do you plan on getting started with an ELN implementation?