Insights On Regulatory Compliance
-
Increasing Automation To Transform CLD Workflows
8/1/2023
Advancements in cell line development workflows have created the potential for greater standardization and automation, eliminating the most common workflow bottlenecks and improving reproducibility.
-
Cell Therapy Process Development Made Easy
3/27/2024
Explore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.
-
Analytical Strategies To Address Common Development Challenges
4/30/2024
Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.
-
Environmental Monitoring For Aseptic Filling
3/6/2025
Explore regulatory interest in modern environmental monitoring for aseptic filling, the benefits of biofluorescent particle counters, and their role in enhancing drug product safety and quality.
-
Equipment Validation In The Pharmaceutical Industry
12/17/2024
Equipment validation ensures pharmaceutical equipment meets regulatory and quality standards. Explore how a structured process ensures compliance, reliability, and high product quality.
-
Trends In Next-Generation Delivery Technologies
11/22/2023
Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.
-
Aseptic Expertise And Delivery Of Services
8/20/2024
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
-
From Open Cleanrooms To Closed Systems – What Is Driving The Change?
3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
-
Closing The 'Knowing-Doing' Gap In R&D Using USP <1062> Data
7/24/2023
Data acquisition system tools have come a long way and now you can learn which trial runs will help you generate the most valuable data.
-
Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques
2/26/2025
Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.