Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
News|Articles|December 3, 2025
Accelerate Cell Line Development with GPEx® Lightning: Speed, Stability, and Industry-Leading Titers
Author(s)Catalent
Catalent’s GPEx® Lightning platform delivers stable, high-yield cell lines with unmatched speed—achieving titers up to 15g/L for mAbs and 11g/L for bispecifics. With 25-day pool generation and up to 12 weeks saved on development timelines, this offering sheet outlines key performance metrics and benefits that make GPEx® Lightning a game-changer for biologics developers.
Related to this article
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill burden, weakly basic drug release, and process limits.
Vibha Jawa, PhD, chief scientific officer at EpiVax, discusses the limitations of current preclinical testing approaches and how new approach methodologies can strengthen drug development.
Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.
Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.
Trending on Pharmaceutical Technology
1
AAPS PharmSci 360 2026: Roller-Compacted Formulations
2
PharmTech Weekly Roundup—October 23, 2026: CMC Considerations, Rare Disease Development, Standards Harmonization
3
From URS to Acceptance Evidence: Defining and Testing Interfaces in Pen Injector Assembly
4
Humanitas Global Health Launches at AAPS PharmSci 360 Event
5