1. What are live biotherapeutic products, and how do they work?
Live biotherapeutic products contain a single species or consortium of live microorganisms such as bacteria or yeast isolated from human donors for use in the prevention, treatment, or cure of a disease or condition. They work primarily by interacting with the host’s microbiome, immune system, or other physiological processes in the human body.
2. Which regions are leading in live biotherapeutic clinical trials, and what drives their growth?
The Asia-Pacific region leads live biotherapeutic clinical trials due to well-defined regulatory pathways to facilitate early-stage development, followed by North America and Europe, reflecting the global expansion of this emerging field. France and Belgium continue to be manufacturing hubs, while in Asia, Japan and South Korea show emerging interest with regional biotech investments.
3. What are the latest advancements in live biotherapeutic products engineering and delivery methods?
Advances in live biotherapeutic product engineering include genetic modification of bacterial strains, and innovations in synthetic biology. For example, LBPs may be designed to sense and respond to cues in the gastrointestinal (GI) tract to alter the host’s biology in situ.
Live biotherapeutic products are commonly administered orally. Developments in oral delivery are aimed at protecting the products from degradation in the GI tract. Some advances in delivery systems include microencapsulation to encase the product in a protective coating to prevent enzymatic breakdown, or by using pH responsive materials that release the therapeutic product in response to specific pH levels across the GI tract.
4. How do live biotherapeutic products integrate with combination therapies to improve outcomes?
Live biotherapeutic products are increasingly being integrated into combination therapies, particularly in areas such as cancer, gastrointestinal disorders, metabolic diseases, neurological disorders, and infectious diseases. These combinations make use of an LBP’s ability to modulate the host microbiome, immune system, and metabolism, making them a powerful adjunct to traditional and advanced therapies. Examples include combination with immune checkpoint inhibitors (ICIs), and anti-inflammatory drugs.
5. What is the regulatory landscape for live biotherapeutic products and how does it vary globally?
Live biotherapeutic products (LBPs) are regulated through CBER by the US FDA and follow the BLA pathway for approval. In Europe, they are regulated through the Committee for Medicinal Products for Human Use (CHMP), as biological medicinal products, and sometimes as advanced therapy medicinal products (ATMP) depending on product characteristics. In Japan, LBPs are generally classified as biological drugs through the Pharmaceuticals and Medical Devices Agency (PMDA).
Genetically modified LBPs differ in regulation amongst regions, with Japan and Europe expecting stricter requirements to for environmental safety and risk assessment.