Pharmaceutical Technology, November 2023

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.

Predictive modeling facilitates the identification of coformers, cocrystal components, and complexing agents.

Interest grows in AI, digitalization, robotics, and sustainability.

Monoclonal antibody and viral vector manufacture share similarities, but vector scale up faces unique challenges.

Using image analysis to characterize complex finished products is crucial in particle analysis.

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

New radiotherapeutic agents are making headway in hard-to-treat cancers.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

Industry investments indicate increasing trust in the newest modalities, including mRNA approaches.

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

Fisher FIELDVUE DVC7K combines patented technology with real-time analytics to provide real-time awareness of valve health.

ROSS’ reconditioned mixers are restored to “like new” working condition by the ROSS OEM team and are designed to perform at the same standard as brand-new equipment while offering cost savings.