09.04.26 -- Can U.S. Policy Bring Generic Drug Manufacturing Back Home?

Early identification of hidden product instability enabled rapid process adjustments, improving yield and keeping a preclinical toxicology program on track despite challenging reaction conditions.

Metal-sensitive analytes often suffer from poor recovery and distorted peak shapes. Learn how inert hardware improves sensitivity and chromatographic performance for challenging analyses.

Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance.

Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

A thorough and adaptable analytical strategy is essential for navigating the complex mAb market. This approach boosts the likelihood of market approval and unlocks the full potential of these therapies.

The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled.

Uncover how aligning impurity profiles between toxicology and clinical drug substance builds translational confidence, supports regulatory readiness, and reduces late‑stage development risk.

Industries rely on advanced storage tanks and pressure vessels to safely manage liquids, gases, and powders. Delve into how custom-engineered solutions can enhance efficiency, safety, and compliance.

Explore how spatial profiling and advanced imaging tools are transforming drug discovery, featuring Wayne Stallaert’s lab’s work on cell cycle mapping and biomarker insights in cancer research.

Moving from benchtop success to broader use requires scalability. Laboratory automation can reduce variability, improve control, and create a more efficient path toward commercial-ready solutions.

Structurally similar impurities can be difficult to separate in GLP-1 therapeutics. See how column chemistry influences selectivity and supports more confident profiling for peptide-based drugs.

Regulatory expectations are forcing a shift away from paper-based validation toward digital systems that enable faster execution, stronger oversight, and more reliable, audit-ready CQV processes.

To accelerate vaccine production, a leading biologics contract manufacturer sought high-speed labeling machines that could be rapidly deployed.

Inline X-ray inspection identifies density variations and foreign contaminants in solid dose products to prevent costly recalls and ensure strict quality compliance.

Ten hard-won lessons from seasoned biopharma professionals cover the foundational habits, verification steps, and process controls that protect batch integrity and prevent costly deviations.

A new regulatory framework reduces PK bridging study needs, helping sponsors streamline device transitions, lower costs, speed up timelines, and boost regulatory predictability for combination products.