Analytical Champions: Robert Wethman

Bristol Myers Squibb’s Robert Wethman discusses real-time spectroscopy, AI, and the next era of biopharmaceutical manufacturing

Category	Detail
Condition	Analytical science in pharmaceutical development and manufacturing
Key Mechanisms	Robust, reliable analytical methods support manufacturing. Spectroscopic methods can increase analysis speed when appropriate; real-time monitoring can provide richer data and more opportunities to optimize quality and efficiency.
Target Population	Analytical scientists and teams involved in pharmaceutical development, manufacturing, process monitoring, and analytical method implementation
Care Setting	Pharmaceutical development and manufacturing; the source describes at-line applications at BMS-owned and CDMO sites.

Increasing complexity of molecules, modalities, and manufacturing processes creates analytical bottlenecks as development timelines compress.
Spectroscopic methods can increase analysis speed when appropriate.
Real-time spectroscopy implementation requires early alignment on goals, limitations, operational impact, and long-term support.
At-line spectroscopy has served as a practical bridge while organizations evaluate full real-time monitoring.
Instrument vendors have made progress in designing technologies for regulated environments, including attention to safety, data integrity, and regulatory expectations.

Wethman emphasizes aligning analytical strategies with development and manufacturing strategies, including decisions about which technologies to use and when to deploy them.
He recommends evaluating the cost versus benefit of real-time spectroscopic monitoring at each product lifecycle stage.
He emphasizes early knowledge sharing and shared understanding of goals, limitations, and long-term support requirements when implementing real-time spectroscopy.
He emphasizes assessing operational impacts and collaborating with operations during implementation.
He describes at-line spectroscopy as a practical bridge while evaluating the need for full real-time monitoring.

Wethman says data quality is fundamental to meaningful process decisions.
He says real-time monitoring can provide richer data sets and more opportunities to optimize quality and efficiency.

Wethman identifies ongoing operational support as a persistent implementation challenge.
He says many CMOs and CDMOs have not yet invested sufficiently in real-time spectroscopy equipment and expertise to drive widespread adoption.
The supplied excerpt mentions vendor attention to safety and data integrity in regulated environments; further equipment requirements are not verifiable from the excerpt.

Not applicable; the article concerns analytical science and pharmaceutical manufacturing, not patient treatment.

No patient prescribing or treatment information is provided.

Wethman describes robust, reliable analytical methods as foundational to manufacturing support.
He emphasizes planning analytical technology implementation with operations and accounting for operational impact.
He says high-quality data are fundamental to meaningful process decisions.
He identifies process greenness as an increasingly important consideration in development and manufacturing.