Automated Small-Scale Tablet Press Aids Development
SMI's Bilayer Nova development and pilot-scale double-layered tablet press is fully automated.
The Bilayer Nova from SMI is a fully automated development and pilot-scale double-layered tablet press with single-layer capabilities. The intuitive human-machine-interface control touchscreen allows full visible access of the machine with accesible controls. The standalone unit does not require any additional consoles or cabinets, which is ideal for tight working environments. The machine has nine-ton, first- and second-layer compression capabilities that are suitable for bilayer tableting requirements. New 'Director Pro' software is designed to reduce operator error and increase product yield. The software will automatically maintain individual tablet weights and reject tablets that are outside of user-specified tolerances.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
