03.05.24 -- Is Pre-Compression Tablet Thickness A True Critical Operating Parameter?

Explore the most recent rewrite of the EU Annex 1 document, as well as the contamination control strategy outlined within.

What are the sources of particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practices when producing sterile drug products?

Learn how a life sciences manufacturer generated a contextualized data set that eliminated the manual effort required to curate production data and improved their process in real time.

Using transposon technology, a substantial improvement can be achieved by pseudo-targeting DNA cargos to integration sites where recombinant protein expression is likely higher in various cell types.

Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance, whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.

As interest in HPAPIs as powerful therapeutic mechanisms continues to grow, drug manufacturers must design thoughtful risk-based containment strategies to protect employees and ensure safety.

Process replication at a small scale, verification runs, and satellite runs conducted in parallel to manufacturing are valuable risk mitigation tools that maximize efficiency and product quality.

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase 2/3 trials.