blog
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…
blog
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…
Case study
Solid Strategic Development Plans Eliminates the Blocking Points for Live Biotherapeutic Product
A French biotech had developed a live biotherapeutic product to target obesity and metabolic disease but were hindered by blocking…
webinar
Ask the experts: EU regulatory framework for microbiome product development
Microbiome-based products, such as Live Biotherapeutic Products (LBPs) are very innovative, therefore associated with many challenges. Navigating the complex regulatory…
publication
Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy
This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding…
webinar
MICROBIOME: Navigating Regulatory and CMC Technical Development Roadmap
Advances in genomic and big data analysis trends have significantly increased the interest of academia in the symbiotic relationship between…
blog
The Microbiome Journey: Development of a Drug Product
In a wide range of therapeutic areas, recent studies have highlighted the link between microbial imbalance (dysbiosis) and the development…
blog
The Microbiome Journey: Development of a Food Product with Health Claims
The microbiome and its relationship to the maintenance of health is a topic that continues to gain more and more…
