02.12.24 -- How Does The GAMP 5 Second Edition Update Look One Year Later?

The foundation for standardizing data across a wide range of raw input data lies in the data model. Review six commonly asked questions people have when considering a data-modeling solution.

We assess the viscosity-reducing capacities of excipients and excipient combinations. The findings demonstrate the impact of protein viscosity on injection force.

Demand for single-use production tools, components, and capabilities continues to grow as innovative cell therapies evolve. However, concerns and misconceptions abound regarding single-use solutions.

Explore data demonstrating the successful engineering of a single-use tangential flow filtration system designed to meet the specific requirements of ADC processes.

The COVID-19 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more.

Learn how a CDMO that prioritizes custom, flexible partnership over a transactional relationship is crucial for long-term programs and for tailoring services to meet the needs of small-volume clients.

More than ever, the quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards.

Quality by design (QbD) is enormously valuable, but often underutilized, siloed, and not operationalized. Discover the benefits of enabling QbD with AI-driven quality operations and batch automation.

Finding a CDMO partner with the requisite expertise, materials, external supply chain, and capacity is key to maximizing a therapy’s chances of commercial success.

Cleanroom systems are purposely designed to simplify implementation of the aseptic manufacturing space that the industry needs to meet future sterile injectable capacity demand.

Drug development is a long and complex process, and every step has specific goals. Explore the relevant objectives and techniques used in each stage of antibody drug development.

Explore the green features and process and operation footprint details of a single-use centrifuge being praised for generating less waste.

In this exploration of improvements in Protein A resins and process improvements in affinity chromatography, get the answers to several questions posed by industry experts.

The best way to clean proteins, RNA, and DNA would be three separate methods. Explore the detailed steps and some of the helpful products.