Newsletter | May 13, 2022

05.13.22 -- New ICH Q14 Guidance Applies QbD To Analytical Procedures

New Podcast Episode
Featured Editorial
Industry Insights
How Oral Solid Coating Technologies Can Enhance Delivery Strategy

With increasing molecule complexity posing growing challenges for formulation and manufacture, oral solids specialists require extensive expertise and cross-team collaboration to ensure project success.

Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

Government Partnership Highlights Blow/Fill/Seal Advantages

Continued global efforts to incorporate BFS in the safe and efficient delivery of lifesaving vaccines are proof that the technology serves as a valuable tool in improving patient care across the world.

Considerations To Purchasing Low Cost-Equipment In Cannabis Manufacturing

No one can deny the cannabis industry is one to watch. Learn how used process and packaging equipment for the marijuana and CBD industry can fill a growing need for manufacturing equipment.

Mixing And Blending Recommendations For Sterile Ingredients
Products manufactured under sterile or cleanroom conditions — for example injectables and vaccines — present different challenges, especially regarding product sterilization.
Particle Engineering For Inhalation Drug Delivery

This article discusses key parameters for choosing the right particle engineering approach to meet dry powder inhaler (DPI) target product profiles for inhalation-based drug products.

Highly Potent Active Pharmaceutical Ingredients Containment

We review a full life cycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.

Regulatory Strategy For Combination Devices By Working With The FDA

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprising of two or more constituents. Read how having an adaptive regulatory strategy is key.

Continuous Flow Manufacturing Of Pharmaceutical Ingredients

Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

Vaporized Hydrogen Peroxide Isolator Decontamination In A World Of Uncertainty: A Modern-Day Field Guide

This field guide uses current published resources to provide clarity and direction regarding best practices for validating decontamination processes using VH2O2.

Efficient Track And Trace Solutions For International Pharmaceutical Company

Serialization and aggregation solutions allow Swiss-based Acino Pharma to serve its international customers quickly and reliably.

Nasal Delivery Technology, QbD Processes, And Outsourcing

Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.

Safe Weighing Range Ensures Accurate Results

We explain the safe weighing range that lies between a scientifically calculated lower limit, determined through calibration, and the maximum limit (capacity) of a balance or scale.

Optimize Development And Upscale Of API/HPAPI And Fermentation Projects

Discover some of the key expectations of customers who are reviewing CMOs to support the development and upscaling of their next major project.

AAV Manufacturing Workflow

Take a step-by-step tour of adeno-associated virus (AAV) workflow objectives, things to consider, and key strategies that will help you achieve a process that’s both efficient and scalable.

Feeder Advancements Improve Cleanability And Automation

This webinar is designed to educate attendees on the newest criteria and engineered solutions available in feeding and material handling for quick and efficient product changeover.  


May 18-19, 2022

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