Dear SAS Members & Friends,

We invite you to our next NY/NJ SAS Monthly Online Meeting on Thursday, May 15th, at 12:00 PM (noon). (online meeting via Microsoft Teams)

NY/NJ SAS Monthly TEAMS Meeting
Meeting link: NY/NJ SAS May 15th 2025 Monthly Meeting | Microsoft Teams | Meetup-Join

Topic: “Multiple Uses of Vibration-Based Spectroscopy in Pharma/BioPharma”

Speaker: Dr. John Wasylyk, BMS

Date/Time: May 15, 2025, 12:00 PM -1:00 PM Eastern Time (US and Canada) log-in begins at 11:50 am

Abstract:
The number of analytical challenges in the development and manufacturing of Pharmaceuticals and Biopharmaceuticals has grown tremendously over the last decade as molecular targets have become more complex, while the focus on sustainability has increased. Applying a broad range of vibrational spectroscopy techniques can meet many of these challenges. In the early development phase, spectroscopy has guided synthetic route scouting by providing rapid analysis of samples ranging from those collected from a single reactor vessel to multi-well plates. The Quality by Design (QbD) approach during reaction optimization and scale-up studies, coupled with various spectroscopy techniques, is enhanced by in-line applications yielding a wealth of process knowledge, such as kinetic data, and defining critical manufacturing parameters. Rapid non-invasive or minimally invasive spectroscopy techniques, when applied to evaluate reagents prior to use during all stages, ensure that reaction quality is maintained, thus limiting the occurrence of sub-par process results. An advantage sometimes not fully expressed is enhanced sustainability with respect to analytical analyses. Shortened analysis time, decreased electrical demand, non-invasive sampling, and little to no sample preparation, as well as ensuring the quality of reagents, are advantages in driving sustainability.

We will present how applying UV, NIR, IR, and Raman spectroscopies in a fit-for-purpose mode aids in the development of active pharmaceutical ingredients. Our application journey will continue through the scale-up process and into the regulated manufacturing environment, where process control becomes paramount to addressing the critical quality attributes of drug substance. Additional focus will be placed on the many sustainable tools which are readily available, such as solvent selection guides, iGAL 2.0 (innovation Green Aspiration Level), and AMGS (Analytical Method Greenness Scorecard) to evaluate overall process greenness. This presentation will highlight the transferability of in-line and off-line spectroscopy methods, the creation of open-access instrumentation, and the positive impact on small molecules and biologics while ensuring reliability, speed, and sustainability.

Speaker Bio:
John Wasylyk received his Ph.D. from The State University of New York at Binghamton in 1989 after which he joined Bristol-Myers Squibb Co. During his first 12 years at Bristol-Myers Squibb Co., he managed a Process Analytical Laboratory in the Fermentation Department. Responsibilities included analytical method development and validation, support for enzymologists, genetic engineers, microbiology as well as manage routine support for a 24/7 pilot plant.

After establishing a dedicated Process Analytical Support Laboratory for the Chemical Pilot Plants at the New Brunswick, NJ site, John focused on vibration spectroscopy to enhance the Process Analytical Technology capabilities in both the laboratory and pilot plant environments. The integration of PAT into Chemical Development included installation of lab and plant spectrometers, chemometric modeling, validation of methods, and transfer to manufacturing sites. Currently, the focus has been on advancing spectroscopy throughout Process Development to improve efficiency, increase process knowledge while driving the sustainability and enhanced safety aspect of in-line and off-line spectroscopy-based analyses in the small molecule and biomolecule arena. John has held several positions in the Society of Applied Spectroscopy, Pharma/Biopharma section chair for The Great Scientific Exchange (SciX) and a co-lead of the Analytical Focus Group of American Chemical Society’s Green Chemistry Initiative, Pharma Roundtable.