INSIGHTS ON DRUG DEVELOPMENT

• Sterilization Of APIs – The Alternative: Sterile Filtration Following Aseptic Processing

  When terminal sterilization isn't an option for heat- or radiation-sensitive APIs, sterile filtration with aseptic processing protects quality. Get the technical framework.

• Three Keys To E&L Success: Study Design, Partner Selection, And Timing

  Successful E&L planning starts before testing begins. Aligning study design, partner expertise, and timing helps teams focus on the right risks, avoid surprises, and support stronger development.

• Particles In High Concentration Biotherapeutics

  Examine advanced analytical solutions that detect, characterize, and mitigate particle formation in high-concentration biotherapeutics caused by protein aggregation and surfactant degradation.

• Formulation Strategies For Enabling "Undevelopable" Compounds

  KinetiSol enhances bioavailability of poorly soluble drugs like Vemurafenib by producing dense amorphous dispersions, outperforming traditional MBP methods in pharmacokinetics and dissolution.

• Building A Science- And Risk-Based Bio-Decontamination Strategy

  10/5/2026

  Annex 1 has made bio-decontamination central to sterility assurance, with isolator and barrier cycles now expected to be designed, justified, and reviewed across their lifecycle.

• Direct qPCR Amplification From Human Urine Samples

  6/9/2026

  Extraction-free qPCR enables faster, lower-cost detection of UTI-associated bacteria directly from urine samples. Explore how this approach simplifies workflows and accelerates time to results.

• Integrating Phase-Appropriate Quality Standards

  12/9/2024

  Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.

• Assessment Of Compound Toxicity Effects With High-Content Imaging

  3/17/2025

  3D cellular models and bioprinting enhance drug safety predictions and offer precise spatial control. Explore an automated method for generating liver models to improve reproducibility and reliability in toxicity testing.

• Redefining OSD Development Through Foresight And Innovation

  2/12/2026

  From early formulation challenges to scale-up and commercial readiness, proactive planning and integrated capabilities help teams anticipate risks, accelerate decision-making, and maintain momentum across development.