Early engagement and regulatory considerations for biotech

whitePaper | May 20, 2022

We are living in a unique time in which the world is changing faster than ever. This largely is due to an influx and infusion of digital technologies that are reinventing and reimagining businesses across nearly every sector, and dramatically shifting societal and economic interactions. While the life science industry has, to some extent, adopted various digital technologies, it has not had a significant digital transformation in how it does business.

whitePaper | May 30, 2022

Many concerns are being expressed about the biodegradability, biocompatibility, and longterm viability of polymer-based substances. This prompted the quest for an alternative source of material that could be utilized for various purposes.

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 | July 13, 2023

Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising therapeutic potential such that their applicability to a variety of therapies is being explored.

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 | November 8, 2022

Using experienced-based best practices and documented tools, ICON has conducted over 63 CGT trials across multiple therapeutic areas from haematology-oncology torare and orphan diseases.