NERDG 2026
Poster 1 Abstract
Developing and Integrating Pharmaceutical Analytical Techniques Lab Platforms for Preformulation, Bioassay and Pharmacokinetic Simulation
Spencer Leonette, Madelyn Kasulinous, Ellie Patterson, Gagandeep Kaur, Aaliyah Mullings, Jayden Mauceri, Vasilios Zanakis, Zeyad Elkaffash, Dylan Mattison, HaiAn Zheng, Marcel Musteata, Kideok Jin, Loraine Silvestro, Richard Dearborn
Department of Pharmaceutical Sciences, School of Pharmacy, Albany College of Pharmacy and Health Science, Albany, New York
Presenting Author: Spencer Leonette
Corresponding Author: HaiAn Zheng, [email protected]
Purpose
A Pharmaceutical Analytical Techniques (PAT) Lab was updated to integrate validated research platforms, including preformulation analytics, mammalian cell-based assays, and pharmacokinetic (PK) modeling. The objectives of this project are to (1) characterize compounds using spectroscopies, HPLC, and LCMS; (2) assess their bioactivities by cellular assays for oncology therapeutics; (3) simulate and extract key PK parameters from bench-top models; and validate them for both industrial training and R&D projects.
Methods
The solubilities and stabilities were quantified and validated using UV-Vis, HPLC, and LC-MS, for unknown/control compounds, e.g., caffeine, riboflavin, methyl red, methyl blue, fulvestrant, palbociclib, paclitaxel, tamoxifen, green fluorescent protein (GFP), and derivatives. Bioassays used EO771 murine breast cancer cells that were cultivated, passaged, and maintained from cryo-stocks. Then compounds were assessed by assays of viability, sensitivity, migration inhibition and wound healing. Also, benchtop fluidic models were used to simulate the PK of Mouse IV infusion (0-90 min) and Rat IV bolus injection. Samples were analyzed and data were fit with PK models, to assess the risks towards steady-state concentration.
Results
Preformulation results validated all calibration curves for chromatographic retention time, absorption λmax, linearity, consistency, integration and limits by HPCL-UV-vis and LCMS. Bioassay results demonstrated dose-dependent reductions in cell viability for active compounds, e.g., palbociclib produced the strongest inhibitory effect. Compounds such as paclitaxel significantly impaired migration with minimal wound closure compared to controls. The Mouse PK infusion dataset showed consistent logarithmic increase of methyl blue towards 20-27 ug/mL by 90 minutes, while rat bolus datasets followed classical exponential elimination. Both PK models responded predictably to changes in dose and elimination rate, confirming reliability. Methodological limitations included LCMS ion suppression and variation, HPLC baseline drift, and insufficient resolution for protein macromolecules on C18-based chromatography.
Conclusion
These experiments aligned preformulation analytics, anticancer bioassay, and PK to assess compound drug-ability, who will be further integrated for new investigations.. The validated results also demonstrated proficiency in instrumental characterization, quantitative PK parameter extraction, and cell-based assay completed by new trainees who obtained lab skills systematically. Collectively, these platforms reinforce how integrated bioanalytical approaches provide a robust framework for both education and early-stage pharmaceutical development.
Keywords
Analytical, Preformulation, Bioassay, Pharmacokinetic, Simulation, Cancer, HPLC, LCMS, Validation
Poster 1 Abstract
Developing and Integrating Pharmaceutical Analytical Techniques Lab Platforms for Preformulation, Bioassay and Pharmacokinetic Simulation
Spencer Leonette, Madelyn Kasulinous, Ellie Patterson, Gagandeep Kaur, Aaliyah Mullings, Jayden Mauceri, Vasilios Zanakis, Zeyad Elkaffash, Dylan Mattison, HaiAn Zheng, Marcel Musteata, Kideok Jin, Loraine Silvestro, Richard Dearborn
Department of Pharmaceutical Sciences, School of Pharmacy, Albany College of Pharmacy and Health Science, Albany, New York
Presenting Author: Spencer Leonette
Corresponding Author: HaiAn Zheng, [email protected]
Purpose
A Pharmaceutical Analytical Techniques (PAT) Lab was updated to integrate validated research platforms, including preformulation analytics, mammalian cell-based assays, and pharmacokinetic (PK) modeling. The objectives of this project are to (1) characterize compounds using spectroscopies, HPLC, and LCMS; (2) assess their bioactivities by cellular assays for oncology therapeutics; (3) simulate and extract key PK parameters from bench-top models; and validate them for both industrial training and R&D projects.
Methods
The solubilities and stabilities were quantified and validated using UV-Vis, HPLC, and LC-MS, for unknown/control compounds, e.g., caffeine, riboflavin, methyl red, methyl blue, fulvestrant, palbociclib, paclitaxel, tamoxifen, green fluorescent protein (GFP), and derivatives. Bioassays used EO771 murine breast cancer cells that were cultivated, passaged, and maintained from cryo-stocks. Then compounds were assessed by assays of viability, sensitivity, migration inhibition and wound healing. Also, benchtop fluidic models were used to simulate the PK of Mouse IV infusion (0-90 min) and Rat IV bolus injection. Samples were analyzed and data were fit with PK models, to assess the risks towards steady-state concentration.
Results
Preformulation results validated all calibration curves for chromatographic retention time, absorption λmax, linearity, consistency, integration and limits by HPCL-UV-vis and LCMS. Bioassay results demonstrated dose-dependent reductions in cell viability for active compounds, e.g., palbociclib produced the strongest inhibitory effect. Compounds such as paclitaxel significantly impaired migration with minimal wound closure compared to controls. The Mouse PK infusion dataset showed consistent logarithmic increase of methyl blue towards 20-27 ug/mL by 90 minutes, while rat bolus datasets followed classical exponential elimination. Both PK models responded predictably to changes in dose and elimination rate, confirming reliability. Methodological limitations included LCMS ion suppression and variation, HPLC baseline drift, and insufficient resolution for protein macromolecules on C18-based chromatography.
Conclusion
These experiments aligned preformulation analytics, anticancer bioassay, and PK to assess compound drug-ability, who will be further integrated for new investigations.. The validated results also demonstrated proficiency in instrumental characterization, quantitative PK parameter extraction, and cell-based assay completed by new trainees who obtained lab skills systematically. Collectively, these platforms reinforce how integrated bioanalytical approaches provide a robust framework for both education and early-stage pharmaceutical development.
Keywords
Analytical, Preformulation, Bioassay, Pharmacokinetic, Simulation, Cancer, HPLC, LCMS, Validation
