The Role of the Digital Laboratory Notebook in Biologics Development

Biologics are transforming healthcare and taking personalized medicine to new heights, bringing with them a new paradigm for drug development. Biologics development workflows involve numerous complex steps like genetically engineering cells, multiple rounds of purification, and process and product characterization. All of this yields large amounts of data, presenting biologics development teams with a data challenge that paper notebooks simply can’t handle. Digitalized, comprehensive data management is the only path forward, making the digital laboratory notebook a critical tool for the modern biologics development team.

A digital laboratory notebook is a crucial tool for early-stage biologics development

Whether a team is developing monoclonal antibodies, CAR-T cells, or RNA therapeutics, they are collecting an abundance of data from instruments and experiments to optimize, monitor, and document every step of the development workflow.

To efficiently deliver products with high quality, purity, and stability, it is critical to have tools that help development teams improve productivity and traceability, facilitate collaboration and knowledge transfer, build robust audit trails and ensure compliance, and preserve data integrity and reproducibility, all while helping candidates get from development to the clinic faster. And it’s the modern digital laboratory notebook that enables all of these functions—all within a single system of record.

While it is true that some electronic laboratory notebooks (ELNs) are too flexible or unstructured for early-stage biologics development, the right kind of ELN helps drive efficiency and compliance with features like configurable templates that can be fixed and secured for structured data capture.

Benchling Notebook, for instance, adapts to development teams’ needs for strict adherence to operational and quality standards. Unlike many ELNs, Benchling Notebook supports the need for structure and control in development workflows, while still providing scientists with a user-friendly, flexible interface.

"For our strain engineering workflow, Benchling has been able to provide an all-in-one environment where we can easily gather day-to-day experiment data in the Notebook and then make meaningful connections to relevant items in the Registry."

– Jay Konieczka, Co-Founder and COO @ enEvolv

Adaptable digital laboratory notebooks improve productivity and traceability

Connecting the dots between your data is crucial for developing the next breakthrough biologic. The ideal digital lab notebook can adapt to and integrate with your existing data ecosystem – your data warehouse, instruments, and other software systems – so you can easily trace sample lineage and experimental history and accelerate your workflows overall.

By integrating with other data sources and software tools, and automatically linking notebook entries to specific samples and all related bioprocessing runs, development teams can efficiently navigate to and between relevant data to answer questions quickly and confidently. This kind of interconnected environment lets you quickly find vector-specific and product-specific results in your notebook and track process outputs such as transfection efficiency, genotoxicity, purity, and yield from multiple runs for every lead candidate and product.

Through open APIs, Benchling Notebook can integrate with and complement any data ecosystem, unifying your entire workflow, eliminating knowledge silos, and increasing efficiency and productivity. And since Notebook is part of Benchling’s own unified platform, you can easily explore your data to identify bottlenecks and optimize the conditions for producing effective engineered T-cell receptors, bispecific antibodies, CRISPR therapeutics, and more.

Adaptable digital laboratory notebooks facilitate collaboration and knowledge transfer

As projects progress from in vivo assays to bioprocessing and product characterization, research, development, and analytical teams need to be able to easily share and find relevant information. However, this is time consuming without sufficient data storage and data sharing tools.

To streamline sample custody transitions and communication across teams, modern digital lab notebooks operate as part of a unified data model, connecting everyone from every team to relevant samples, results, and experimental history at every stage of the R&D life cycle. These digital lab notebooks pair with a centralized data warehouse and bidirectionally link notebook entries to samples and data. This helps cross-functional teams get a clear view of what has been done and allows them to initiate the next step in the development process smoothly.

With Benchling Notebook, data is easily shareable across development so that teams in bioprocessing and bioanalytics can save time generating reports, handing off results, and uploading results, ultimately improving collaboration and overall productivity.

Benchling Notebook reduces time to data entry by 85% when replacing legacy electronic lab notebooks.

Adaptable digital laboratory notebooks ensure data integrity and reproducibility

Standardizing data capture and experiment documentation across users, teams, and studies is a laboratory best practice when it comes to driving efficiency, accuracy, and reproducibility. A commonality across bioprocess development is system silos, where every team uses a unique LIMS that is disconnected from the software systems used by collaborating teams. Moving to an electronic lab notebook that sits within a unified data management platform unites these distinct teams in their efforts to accurately capture, relay, and reproduce data by reducing system silos – and therefore information silos.

To further ensure data integrity and reproducibility, electronic lab notebooks (ELNs) that allow you to develop customized entry templates with predefined protocols, checklists, and tables can help you standardize numerous tasks, from vector expansion through release testing, across your development workflow.

Since the Benchling Notebook also integrates with your instrument and software ecosystem, you can both standardize and automate data capture, vastly improving the reproducibility of your experiments at scale.

• Record your data automatically and immediately, avoiding errors that can occur from manual entry;

• Set up your next assay exactly the same way it was previously performed by quickly navigating to the last notebook entry with relevant protocols and results; and

• Compare results between experiments and past product generations to ensure consistency.

Adaptable digital laboratory notebooks ensure compliance

Because biologics are produced by living cells, the process as well as the product must be validated and strictly monitored throughout manufacturing. To maintain compliance and generate reliable products, labs need to thoroughly track data on not only the end product, but also the critical quality attributes, process, equipment, consumables, and cell lines that went into the production. Without proper record-keeping, compiling documentation on all of this for approval can quickly become frustrating, time-consuming, and worse—insufficient for approval.

Good digital lab notebooks not only help build robust audit trails, collate key data for review, and ensure regulatory compliance–they make these activities faster and easier so you can reach a successful IND submission as quickly as possible. The same standardized templates and automated data capture capabilities that bolster data integrity and reproducibility also make it easier to enforce standardized, fully traceable, up-to-date record keeping so your lab is always audit-ready.

Benchling takes this a step further and provides customizable witnessing and review processes, with electronic signatures, audit trails, and automatic versioning so you never lose critical information.

Benchling Notebook streamlines experiment documentation, collaboration, and knowledge transfer — all while ensuring your teams remain in compliance with organizational SOPs and regulatory requirements — with features like:

• Customizable entry templates

• In-line entity registration and inventory management

• Configurable, assay-specific data capture tables

• Audit trails and version control

• 21 CFR Part 11 compliant e-signatures

ELNs for the future of biologics development

By improving productivity and traceability, collaboration and knowledge transfer, data integrity and reproducibility, and compliance, ELNs that are part of a unified data management system have the power to reduce roadblocks and information silos that stymie speed to clinic. The future of biologics is bright, and it is time for life science to step out of the shadow of outdated software by harnessing the power of modern digital lab notebooks.

Get the optimal digital solution for your lab by reading Benchling’s ELN ebook: Taking your lab digital: What to know about bringing electronic lab notebook technology into your R&D lab