Overcome Early Stage Bioprocess Data Management Challenges

Learn how a unified informatics platform can help USP and DSP teams to collaborate and optimize processes

Creating a successful therapeutic agent is the end goal of bioprocess engineering. This process involves a careful understanding of the most desirable conditions for production, and then reproducing these conditions during scale-up. Frequently this data is stored across many lab notebooks, lab instruments, and different departments throughout the organization. This separation of data makes it difficult to effectively and quickly pull information together, and to tell the full story of what is happening in the lab.

The Data Challenge of Bioprocess

Process development and optimization in Upstream Processing (USP) includes many different variables: cell line development and engineering, cell clone selection, media and feed development, bioprocess development and scale up, reactor design, cell harvesting, and process control and analytics. By changing and testing these variables, possibly independently, a large amount of data is created.

Creating large amounts of data, comes with its own challenges: How does a USP team quickly and efficiently provide data to the Downstream Processing (DSP) teams? How can research leaders quickly access this data to make informed decisions? How can you track the origin of an impurity?

If an informatics platform is used throughout an organization, it enables biopharmaceutical companies to track every piece of data generated across different labs, from cell line selection to pilot scale up. Scientists using a cohesive platform can more easily search and report on data at any step in the bioprocess workflow. This significantly reduces time spent on troubleshooting and optimizing upstream and downstream workflows.

An Informatics Platform Helping Scientists in the Lab

Sample Situation 1

Imagine a scientist in the lab who is asked to quickly pull together all data associated with a particular laboratory-batch of product for the senior leadership team by end-of-day. This “drop everything” situation can be an onerous task. Typically, to retrieve the data, the scientist would need to track down all lab notebooks, spreadsheets, and fellow scientists involved in the creation of that batch. The scientist would then spend time recreating the study and piecing all data together, while dealing with potentially conflicting or missing data from spreadsheets.

By using an informatics platform, this task becomes streamlined, because the scientist can quickly review the lineage of the laboratory batch in question and report on all associated data with that batch, including who ran what assay when it was done. The scientist can be confident in the data and findings, because there is one source of truth of all information in the platform. Reports can be pulled quickly, without wasting time deciphering handwriting, guessing at the difference between conflicting data or trying to extract information from someone’s head.

Sample Situation 2

As the drug candidate is being scaled from a laboratory scale batch to a pilot scale batch, a situation may arise where a scientist in DSP determines that there is an impurity in the batch. But where did this impurity come from? With an informatics platform, the scientist in the DSP team can easily determine all reagents and associated results with the batch to look for any indicators of an impurity. The scientist can also quickly review all scale up studies performed on the drug candidate to look for any possible discrepancies. The ability to perform these troubleshooting tasks within one system, allows for a more rapid and thorough investigation.

Solving Data Challenges with the Platform for Science

The Platform for Science can help scientists and laboratory managers overcome their bioprocess data challenges. The Platform for Science provides a single source of truth for all data captured and reported for a pilot batch of drug product.  It is a single platform solution, that allows end-to-end sample and specimen tracking across experiments and assays.

The data collected in the Platform for Science is available for any point in the bioprocess stream. To create a laboratory or pilot scale batch of a drug, upstream and downstream processing teams must work closely together. To efficiently work together and make informed decisions, upstream and downstream processing teams must be able to easily retrieve, share, track, and report on data produced within their teams. With the Platform for Science, laboratory managers and scientists have the ability to quickly generate reports to enable knowledge transfer between USP and DSP teams, as well as senior leadership.

For more information on bioprocess solutions available for the Platform for Science, read our blog, Manage Track and Optimize Bioprocess Workflows – New Bioprocess Applications Available for the Platform for Science and/or read our bioprocess brochure (automatic download).

Laura Trudeau is a Scientific Marketing Specialist for Core Informatics. Laura worked in Bioanalytical Development at Alexion supporting R&D, preclinical and clinical projects. She has performed assay development and clinical analysis under FDA, MHRA, and EMEA regulations.