Are Nitrosamines a Concern for Biologic Manufacturers?

whitePaper | October 27, 2022

The cell and gene therapy (CGT) market is rapidly transitioning from ultra-niche cutting-edge science to approved and available therapies that can address previously intractable and often devastating diseases.

whitePaper | August 11, 2022

Reliable and accurate cell counts are crucial for many different purposes such as the maintenance of cell cultures in biological research or in-process controls in industrial bioprocessing.

whitePaper | August 25, 2022

Patient engagement has become a measure of healthcare analytics that many in rehab therapy have sought to quantify.

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

whitePaper | June 23, 2022

Cell and gene therapies require both efficient and reliable freeze-thaw systems. Building the most effective system depends on selecting the right materials and instruments.

whitePaper | March 22, 2023

If scaling issues strike you as obvious or even boring, you should read “On Being the Right Size,” a 1926 essay by geneticist J.B.S. Haldane. It makes the case that a difference in scale—a seemingly simple matter—may demand subtle changes in form and function.