Leveraging innovations in plasmid manufacturing to bring advanced therapies to market

whitePaper | January 4, 2022

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.

whitePaper | November 10, 2022

The call for achieving representative diversity in clinical trials and development programs is not new and indeed dates back more than five decades in the United States but has been amplified over the course of the COVID-19

whitePaper | November 4, 2019

Revenues from biologics increased by 70% from 2011 to 2016. Biologics account for 20-22% of total pharmaceutical spending. IQVIA estimates US biologics spending will reach $320bn by 2023

whitePaper | March 30, 2023

The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered atrisk.

whitePaper | November 11, 2022

Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi, respectively.

whitePaper | March 16, 2021

Cell and gene therapies have emerged as a new treatment paradigm, and with them has come the potential to alter the course of many rare diseases. In many cases, there is an opportunity to correct the underlying dysfunction with a one-time administration of a therapy and provide either a functional cure or a substantial improvement in health outcomes. In other cases, long term symptom relief will be the primary therapeutic objective. Some of these indications may require more than one dose to achieve continued symptom relief and scientists and companies are working on technologies that will enable the use of a repeat dose.