Leveraging innovations in plasmid manufacturing to bring advanced therapies to market

whitePaper | December 5, 2022

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

whitePaper | May 10, 2022

Biotechnology companies are at the epicenter of innovative drug development, with discoveries spanning from small molecules, large molecules, and biologics to genomic medicines

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 | February 15, 2023

The diverse therapeutic attributes of mesenchymal stromal cells (MSCs) lend to their rapid development as cellular therapeutics. These unique attributes include potent immu nomodulatory properties [1,2], the potential to differentiate into multiple cell lineages.

whitePaper | August 21, 2022

The “Government Performance and Results Act” and the “GPRA Modernization Act of 2010 require federal agencies to develop strategic plans setting forth long-term goals and objectives. Guidance.

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.