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Expertise Library Real-Time Monitoring of Downstream Biologics Operations

Real-Time Monitoring of Downstream Biologics Operations

Fast, Multi-attribute Process Information from a Single, Inline Process Analytical Technology

The complexity of modern biologics, along with increased titers and efficiencies from upstream processes, have highlighted challenges in many downstream processes. Scientists and engineers report that process limitations and knowledge gaps can require extended periods to address with traditional offline techniques. Greg Lane of Bristol Myers Squibb reviews the use of in-situ monitoring Process Analytical Technology (PAT) to characterize and optimize processes faster and with less effort.

Tangential Flow Filtration (TFF) is a common unit operation in downstream drug substance production and drug product formulation and requires extensive manual interactions and sampling for process characterization. Multiple methods may be required to measure or characterize each critical component; but results are subject to resource limitations and turn-around of analytical services. Fast and quantitative measurements of multiple components, simultaneously and in real time, is possible with in-situ spectroscopy.

This presentation details how to model critical components in TFF processes and rapidly quantify protein and excipients in real time. Unexpected process behaviors such as non-ideal excipient permeation or predicted Gibbs-Donnan membrane effects are observed, including at high-concentration and high-viscosity conditions.

In-situ spectroscopy applied to TFF:

  • Eliminates knowledge gaps by monitoring the entire process inline and without the need for manual sampling
  • Enables informed and immediate decisions by obtaining data in real time – without the need for analytical services
  • Automates the recording of comprehensive and structured data
  • Enables process automation and feedback control
  • Reduces manual interactions and enables scientists to focus on high value tasks

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About the Presenter

Greg Lane

Greg Lane

Bristol-Myers Squibb

Greg started at Bristol-Myers Squibb Company as a PhD Organic Chemist in the Small-Molecule API Process Technology Department. During that time, he developed scaleable syntheses and utilized Process Analytical Technology (PAT) to monitor reactions and crystallizations from the lab to the pilot plant. In 2016, he moved to the Drug Product Science and Technology department, with a focus on oral solid dosage forms and biologics production. His efforts involve using Raman and other PAT to monitor and control upstream bioreactor production. This led to requests to be able to monitor downstream unit operations. As Greg likes to say: “Proteins are molecules, too!”