01.29.26 -- 5 FDA Approval Categories In 2025

Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.

Asian manufacturers are constantly under pressure to produce high-quality products on time. Explore how Asian pharmaceutical companies are leveraging MES to enhance efficiency and compliance.

Examine pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

Discover innovative strategies in process intensification to boost mAb production and hear from industry experts as they share solutions for scaling efficiency and navigating regulatory challenges.

Overcome data integrity challenges in your bioanalytical lab. Learn how a connected data strategy streamlines operations and enhances regulatory compliance.

Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.

See how incorporating small amounts of mesoporous silica during micronization can significantly enhance powder flow, thereby making subsequent formulation more efficient and consistent.

Surplus and idle equipment can lead to decreases in workspace and work efficiencies for a manufacturing site. Gain insight into how you can get paid for them and clean up your workspaces.

Ensure unmatched product quality with an X-ray system paired with an innovative software that detects contaminants and missing items in stacked packaged goods with precision.

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Delve into the suitability of needle-free polycarbonate transfer devices.

Read about a streamlined workflow that improves reproducibility, reduces contamination, and simplifies single-cell proteomics with comparable results to FACS.

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

As capacity expands and capabilities mature, CDMOs with global scale and advanced injectable expertise are becoming critical partners for bringing complex sterile drug products to market.

Asher Biotherapeutics was seeking a CDMO that could handle Phase 2 through to commercial production, as well as taking early-stage projects in its pipeline all the way through their lifecycle.