Agile Process Development In Biopharmaceuticals

whitePaper | September 17, 2021

The adoption of CAR T therapies in the UK NHS is a success story, especially seen in relation to the experience in many other countries. The UK NHS showed itself to be agile, and responsive to addressing the unique challenges these therapies present, which facilitated access to patients earlier than in many other countries. (including delivery centre selection, development of service specifications, collaboration with manufacturers throughout the preparation phase for adoption, establishment of national multidisciplinary CAR T team to ensure equity of access and prioritization of resources (where needed)).

whitePaper | November 12, 2019

This document describes a novel Quanterix lysate diluent for running lysate samples with Simoa assays diluent.

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 | August 22, 2022

Biosimilar therapies offer more unique approaches to treating patients with serious diseases, such as cancer.

whitePaper | December 9, 2022

There is an upward trend for pharmaceutical companies to ask their contract development and manufacturing organisations (CDMO).

whitePaper | October 21, 2022

Just as thieves developed a new interest in explosives following the 1861 invention of the combination lock—and the concurrent rise in the popularity of bank vaults.