Genetic insights for biopharmaceuticals: Propelling drug candidates into therapeutic assets

whitePaper | January 31, 2023

The first biosimilar approved under the abbreviated pathway established by the Biologics Price Competition and Innovation Act launched in the U.S. in 2015.

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 | May 27, 2023

The Human Genome Project was a monumental effort over more than a decade to determine the human DNA sequence and analyze genetic variation among individuals. The hope was that, armed with this understanding, phenotypic differences would be explainable by genetic variation, and health benefits could follow.

whitePaper | December 20, 2022

The current processing paradigm of large manufacturing facilities dedicated to singleproduct production is no longer an effective approach for best manufacturing practices.

whitePaper | August 19, 2022

The quality of procedures and products used for preparing, transporting and storing cells at cryogenic temperatures have a direct impact on post-thaw viability and functionality, as well as the consistency and reliability of biological agents from a Quality perspective.

whitePaper | April 20, 2023

In the three decades that have passed since the approval of the first gene therapy in 1990, these revolutionary medicines have changed the lives of patients all over the world1.