Integrated Biologics: Enabling high throughput drug discovery at Amgen

whitePaper | April 16, 2020

Accurate diagnosis is the cornerstone of medicine; it is essential for informed care and promoting patient and family well-being. However, families with a rare genetic disease (RGD) often spend more than five years on a diagnostic odyssey of specialist visits and invasive testing that is lengthy, costly, and often futile, as 50% of patients do not receive a molecular diagnosis.

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 29, 2022

The market is experiencing a surge in the availability of cell and gene therapies (CGTs); it’s estimated that by 2025 as many as 20 will be introduced into the US each year.1,2

whitePaper | August 5, 2022

The field of gene and cell therapy is experiencing a renaissance, with innovations in the use of viral vectors as a gene delivery vehicle being a key factor in the field’s growth.

whitePaper | November 17, 2022

Gene therapy is the modification of specific genes in targeted cells in order to address genetic mutations that cause some of the most debilitating human conditions.

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.