Unlocking the potential benefits of Live Biotherapeutic Products (LBPs) for the treatment of bacterial vaginosis…
Introduction Bacterial vaginosis (BV) BV is a common vaginal condition characterised by odorous grey vaginal discharge which can be really…
Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the…
Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various…
Overcoming the key hurdles in the development of Phage Medicinal Products
We have seen in the first part of our Phage therapeutics Series that Phages, these viruses that can infect and provoke…
Building an Efficient Path Towards Phase 2 Clinical Study in the US for a Live…
An APAC-based biotech had developed a live biotherapeutic product to target a rare liver disease with a high unmet medical…
A deep dive into the regulatory framework for Phage Medicinal Products
Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
Ask the Experts: How to use microbiome as an innovative diagnostic tool
Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling…
The EU Regulatory Framework for Microbiota Transplants: An Industry Perspective
The current European regulatory framework for Blood Tissue and Cells is being replaced by a new Regulation, which includes a…
Cell banks characterization expectation for microbiome therapeutical products
The last decade has marked the emergence of numerous microbiome treatments investigated in clinical trials. With a broad landscape, spanning…