Mark Woolf
Understanding Cold-Chain Shipping Challenges and Comparing Solutions for Temperature-Sensitive Product Handling The number of biologic new molecular entities approved by the U.S. Food and Drug ...
Ratish Krishnan
Gene therapies have come a very long way since the first clinical trials back in the early 2000s. Viral vectors and adeno-associated viruses (AAVs) have been studied for over 50 years, and their ...
Nice Insight
The ex vivo cell and gene therapy medicine field has entered into a new era driven by the registration of the first autologous products, namely Kymriah (Novartis, 2017, U.S.), Yescarta ...
Ron Laethem, Ph.D.
Gastrointestinal (GI) issues are common side effects of many drugs. Anticipating such side effects before clinical trials is limited by a lack of effective models for evaluating preclinical ...
Mark Woolf
Understanding Cold-Chain Shipping Challenges and Comparing Solutions for Temperature-Sensitive Product Handling The number of biologic new molecular entities approved by the U.S. Food and Drug ...
Bailey Zwarycz, Ph.D
Both current in vitro and in vivo models used in the development of candidate therapies for the treatment of intestinal diseases have severe limitations. RepliGut®, an in vitro human intestinal ...
Ulrich Reichert, M.D.R.A.
Nitrosamines, potentially carcinogenic compounds, were first discovered at unacceptable levels in valsartan-based blood pressure medicines in June 2018. Since then, they have been found in other ...
Ratish Krishnan
Gene therapies have come a very long way since the first clinical trials back in the early 2000s. Viral vectors and adeno-associated viruses (AAVs) have been studied for over 50 years, and their ...
Daniela Kovats
Contract development and manufacturing organizations (CDMOs) face the challenge of managing new active pharmaceutical ingredients (APIs) in development projects with less toxicity and ...
Vikas Revankar
The timeline, complexity, and cost involved in advancing biologics from lead identification to patient delivery is tremendous. The synergy of process intensification and digital technologies ...
Bailey Zwarycz, Ph.D
Intestinal inflammatory diseases are highly complex, which has thus far prevented development of an effective in vitro disease model. With access to a donor-derived cell biobank and the ability ...
Liz Boazak, Ph.D.
Advanced microphysiological systems can replicate aspects of intestinal complexity, such as epithelium self-renewal by stem cells in in vitro crypts or the interactions of microbes and ...
Gerhard Noessner, Ph.D.
The key to successful development of safe, efficient, and cost-effective active pharmaceutical ingredient (API) production-scale processes is the application of smart chemistry and process ...
Lisa Caralli, Matthew Rota, Jim Spavins
Approximately six out of 100 molecules make it from the discovery stage to phase III clinical trials (Figure 1). The attrition of the other 94 molecules represents a gap in early-stage ...
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