05.23.25 -- What FDA Draft Guidance Tells Us About In-Process Control Strategies

Streamline your drug development with AI. Enhance process intelligence and achieve gold-standard data sets with the right digital tools and improved maturity.

Scientific literature reviews are crucial for HEOR decision-making but notoriously slow. Explore how AI can potentially accelerate evidence synthesis while maintaining necessary scientific rigor.

Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.

Learn about FDA regulation 21 CFR Part 11 and the critical role it plays in ensuring pharmaceutical and medical product manufacturers properly manage and track their data.

Discover the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.

Watch to gain knowledge about biological indicators, D-value, and the differences in steam sterilization for liquid and solid loads.

Delve into the complexities of scaling decisions to gain insights from biopharma developers and a CDMO. Reveal more about their mutual interest in achieving successful scale-up and strategies.

Although well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

Find out how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

Uncover a collaborative automated sample handler that eliminates manual sample handling, enabling groups to test larger sample sets and collect statistically significant data while freeing up analysts’ time.

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

Ensure Annex 1 compliance through robotic isolators, PUPSIT, contamination control strategies, and rigorous training for aseptic sterile fill-finish of early-phase clinical products.