01.18.24 -- Is FDA's COVID Container Closure System Guidance Useful Post-pandemic?

Innovative drug-eluting implants, inserts, and transdermal films delivering biologics and small molecules can meet the goals of patient-centric therapies, improved medicine, and better healthcare economics.

We share an overview of integrity tests where high sensitivity is required to prevent the risks of stability failure of highly moisture-sensitive drugs or biological ingress of sterile parenteral drugs.

The unique demands of remote work can require institutions to fundamentally change their organizational structure to empower the use of remote work tools and strategies.

In this study, we present a second-generation purification procedure for adenoviral vectors based on monolith chromatography that secures safer products and enhances purity at higher yields.

Learn more about defining the spray drying process with an emphasis on specific enhancements to accommodate scale-up to commercial-scale equipment of challenging applications or molecules.

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.

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.

Explore the processes and technologies being utilized by life sciences manufacturers to achieve success on their industrial DataOps maturity journey, as well as real-world best practices from the field.

This handbook is intended to assist laboratory and manufacturing plant scientists and engineers in accurately selecting and maximizing the performance of aqueous cleaners and systems.

A majority of methods used to detect pinholes, cracks, and defective seals in containers are destructive. Learn about high voltage leak detection (HVLD) and why it is free from these shortcomings.

John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.

Use a gene expression system that allows you to produce molecules that are 100% free of fucose and demonstrate increased potency, without compromising on titers, growth, stability, or product quality.

Minimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.