02.01.23 -- Frequent Deficiencies In GMP Inspections, Part 3

Identifying variations in the expected nutrient profile before its use may prevent undesirable culture outcomes such as poor growth and low productivity.

Immunogenicity assessment is an area where "standard" in vivo toxicology assessments might lack clinical relevance. Get an expert view on early immunosafety assessment challenges and risk mitigation strategies.

Explore our tips for single cell isolation and how to ensure optimal results across several key application areas.

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.

While extracellular vesicles represent significant opportunity for the biologics space, researchers are still building a foundation of knowledge surrounding their biology, application, and ultimate value.

Manufacturing complex and highly potent ADC treatments presents unique challenges. Get an insider look at how these treatments make it from development to commercialization.

We give an overview on the theory of scaling, present workflows and strategies, discuss which data are needed for successful scaling, and present case studies that use a web-based scaling tool.

Continuous capture chromatography allows for improved resin capacity through continuous loading of multiple columns in series, reducing the cost of goods.

Learn how incorporating multiple methods of quantification and quality assessment can ensure accurate viral titers of high quality and safety for use in people.

This notebook from the Biopharmaceutical Scientific Operations Team at Waters illustrates key attribute monitoring workflows to improve and streamline MAM analysis of biotherapeutic proteins.

A gene therapy’s path from the research lab to the clinic and, ultimately, the market requires manufacturing processes that will meet the regulatory requirements and logistics to get therapies to clinical trial sites.

Plug and play platforms can be adapted to different therapeutic genes without starting the development from scratch for each product, making the transfer to GMP as fast and smooth as possible.

In this study we share the results of our recent partnership with Merck to perform an in-house evaluation of the DynaDrive S.U.B system to get a hands-on feel for the ergonomics of the new bioreactor technology.

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner.