Search results for "development"

Article Relationship Building at Top of Mind for Clients
Add to this the uncertain nature of process development and problems that invariably arise, and it is easy to see how scheduling can be challenging. That doesn’t make scheduling any less important,…

Article Single-Use and Continuous Processing Technologies Change Facility Design
With technology development ongoing, prices are still relatively high and the supply chain has not been totally optimised, but in 10 years, SU will be more widely accepted. In parallel, another ch…

Article Analyzing Proteins Using SEC, MALS, and UHPLC
The combination of SEC with downstream light scattering analysis and the development of columns that can be used for ultra high-pressure liquid chromatography (UHPLC)-based SEC are overcoming many of …

Article Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance. With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …

Article FDA Seeks Metrics to Define Drug Quality
To move more breakthrough drugs quickly through the approval process, pharmaceutical and biotech companies need to establish high quality production systems early in development. These imperatives put…

Article Advancing QbD in the EU
These guidelines cover pharmaceutical development concepts in Q8, quality risk management (QRM) in Q9, and a pharmaceutical quality system to be implemented in the different stages of a product lifecy…

Resource American Society of Mechanical Engineers
The American Society of Mechanical Engineers (ASME) is a not-for-profit membership organization that enables collaboration, knowledge sharing, career enrichment, and skills development across all en…

Article Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…

Article Optimizing KiH bispecific antibody chromatography steps
Bispecific antibodies (bsAbs) are a promising class of therapeutic agents due to their ability to bind to two different types of antigens or two different epitopes on the same antigen. This a…

Article Introducing the VH3 ligand ELISA kit
This kit is essential for users of MabSelect™ VH3 resin in process development and production, providing a comprehensive and reliable solution. Learn more about the VH3 ligand ELISA kit and view de…

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