BioReliance End-to-End Biopharm Process Development

Case Study

Background

The BioReliance® End-to-End (E2E) Biopharm Process Development laboratory in Burlington, MA enables its clients to reduce the time required to develop and produce cGMP biomolecules for clinical trials. A mid-sized facility, the E2E lab provides the support, equipment and expertise that smaller biotechs need to test and build their drugs and processes—from DNA all the way to the purified drug substance for clinical trials.

In order to deliver maximum value to their customers, the E2E lab needed their development processes to be efficient, reliable, and reproducible. However, the disparate data sources and workflows of their upstream instruments presented the team with considerable logistical challenges.

In a typical 15-day fed-batch process, samples would be taken from each of the lab’s six or more bioreactors and then analyzed offline using four different upstream instruments: a metabolic analyzer, cell counter, osmometer, and blood gas analyzer. Each sample run would generate up to 25 data points that would be written down by hand, pasted into the batch record, and then manually copied into an Excel spreadsheet for further calculation; or roughly 300 data entries per day on a typical process.

All told, more than 4,500 data points would need to be manually transcribed over the course of 15 days, and a second scientist would be required to ensure all data was accurately transcribed. It was a very tedious, error-prone process that took about 90 minutes per day, while generating binders and binders of unsearchable paper records.

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Executive Summary

A mid-sized bioprocessing lab connected four upstream instruments to BrightLab, with the following results:

  • The automation of data collection, tagging, and storing resulted in an 80% reduction in manual steps, saving the lab 90 minutes per day from manual data entry.
  • The lab’s data is now centralized and synced into a single source, which can be accessed from anywhere with real-time monitoring.
  • With significantly reduced paper documentation, the lab’s data is now digitally stored in a secure, searchable archive.
Bioprocess Workflow

BrightLab and TetraScience Solution

With the intended goal of increasing productivity, reducing overhead costs, and consolidating data, the E2E lab consulted with BrightLab and TetraScience to determine the feasibility of connecting their most important upstream instruments to the digital platform.

After a preliminary on-site analysis of workflows and data collection methods, the BrightLab and TetraScience teams devoted strategies to connect and parse data from different instruments—including file syncing, API connectors, and direct connectivity using Internet of Things (IoT) devices.

Data from all the instruments now gets automatically transferred to BrightLab and is parsed into a standard JSON format for storage in a data lake. All this goes on behind the scenes, but now the researcher is able to select files, add metadata such as sample information, search and filter data, and export to Excel. Best of all, with a single click, a researcher is now able to generate a report in a user-defined format.

The implemented solution also supports API access to the data, so that the BrightLab ELN and other third-party systems can pull from the centralized data lake, and instrument data can be checked anytime, remotely.

Results

By connecting four upstream instruments that are used in a typical bioprocessing workflow into BrightLab, the BioReliance E2E lab drastically reduced manual data entry and documentation, resulting in a more streamlined process.

» With the BrightLab solution we anticipate significant improvements in efficiency, saving around 90 minutes every day, mostly on data entry. Data is automatically loaded into Excel, eliminating multiple manual steps. This eliminates transcription errors and paper binders, and also eliminates the second reviewer when we are transcribing this data into the Excel set. «

– Keshab Rijal, Research Scientist for the End-to-End Lab.

Even before the team had been fully trained on BrightLab, it was immediately evident that the E2E lab’s new connected solution would represent a significant time savings. While the lab previously had to manually capture, tag, store, parse, and analyze data individually for each instrument, they are now able to automate those steps for all the upstream instruments in a single workflow—an 80% reduction in manual steps. The data is now consolidated in one central location that is searchable, archivable, and in a format that can be readily shared with customers. Plus, the E2E lab was able to eliminate the need for a second reviewer entirely, which freed up their team’s resources for more valuable scientific work.

Bioprocess Before and After

» The data is now more available to monitor in real time, is searchable, and archived. With this solution, I can now focus on making the process better. «

– Keshab Rijal, E2E Research Scientist

Conclusions and Next Steps

Now that the BioReliance E2E lab has implemented the BrightLab and TetraScience solution, their next steps involve sustaining the success they have already realized, training more staff members on the solution, and making their processes even better.

In addition to the four upstream instruments that are connected in a single process workflow, 10 additional downstream instruments have also been individually connected, so that the raw data can be captured, parsed, and ported into BrightLab (see the box for the complete list of connected devices). For the downstream processes, the E2E lab is looking into how they can streamline and better utilize the instrument data at their disposal.

Looking ahead, the E2E lab is evaluating the use of BrightLab ELN and expanding their use of BrightLab Inventory Management as a way to simplify storage of process information in one location. With the instrument data already in a central hub, being able to access the project plans, protocol language, raw materials, and data in a single repository would represent additional significant gains in efficiency and cost savings.

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