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

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.

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.

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.

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.

Products manufactured under sterile or cleanroom conditions — for example injectables and vaccines — present different challenges, especially regarding product sterilization.

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.

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

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.

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.

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

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

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.

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.

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

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.

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.