12.02.25 -- 9 Drugs Granted Fast Track By FDA's Voucher Program

Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.

Explore the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.

Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies.

Examine how orchestration software enables flexible, automated control across chromatography, filtration, and UF/DF operations, all while supporting compliance and scalability.

Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Uncover the impact of the evolution of synthetic biology and supporting technologies.

API-in-capsule offers a fast path for early clinical data, but it can't eliminate the need for full formulation development. Weighing the potential for higher total development time and cost is critical.

Manual processes in CMC development create costly delays and compliance risks. Discover how digitization can eliminate bottlenecks, improve traceability, and accelerate timelines.

New materials, smart automation, and in-press quality control are optimizing tablet compression. These five key innovations are driving efficiency and consistency in solid dose manufacturing today.

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Review a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.

Leveraging computer-aided synthesis design technology and route scouting in the early stages of development can aid you in designing an efficient and cost-effective path to API manufacturing.

Find out how modern strategies like the CCS are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative methods.

Modular cleanroom systems are increasingly chosen over conventional construction due to their accelerated design and installation schedule, as well as their reduced job-site safety risk.

Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.

Watch how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for reformulation or repeated preclinical or clinical studies.

Learn about a disposable pen that is a proven, globally adopted drug delivery platform with over 175 million units sold, supporting diverse therapies in 40+ countries.