Optimizing Freeze-Thaw Processes for Cell and Gene Therapy Commercialization

whitePaper | April 24, 2023

Implementation of a metabolite-based cell density<br /> estimation and evaluation of harvest strategies for<br /> Lentivirus production with HEK293T cells

whitePaper | October 28, 2022

Adoptive cell therapy (ACT), a branch of immunotherapy, offers a promising treatment for chronic viral infections and malignant diseases such as cancer [1]. This innovative approach involves the autologous or allogenic transplant of immune cells into the patient’s body.

whitePaper | December 16, 2021

Use of cells, tissues, and gene therapy products for the treatment of diseases or 72 physiological conditions has become of wide interest due to their potential to address serious 73 unmet medical needs.

whitePaper | December 7, 2022

OVER THE LAST 20 years, the worldwide value of traded pharmaceutical goods has grown six‑fold, from $113 billion in 2000 to $629 billion in 2019.1 Yet amid such robust growth comes risk to supply chain security as manufacturers become increasingly dependent on a global network of suppliers

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 | September 27, 2022

Cell and Gene Therapy (CAGT) activity has increased dramatically in recent decades, especially in Chimeric Antigen Receptor T-Cell (CAR-T) clinical trials and therapy registrations. The IQVIA CAGT Hot Buttons series covers basic concepts in CAGT for newcomers to this field.