Live Biotherapeutic Products
A microbiome is a collection of genomes or microbes in a system. The term Live Microbial Product (LMP) or Live Biotherapeutic Product (LBP) refers to products containing whole, live microorganisms, such as bacteria or yeast with an intended therapeutic or preventive effect in humans, regardless of the route of administration (oral, topical, intravenous, etc.).
LuinaBio’s experience in producing Live Biotherapeutic Products, with both aerobic and anaerobic organisms, includes the development of scalable and fully closed axenic production processes. There is limited manufacturing capability throughout the world and our expertise in both development and production makes LuinaBio the perfect choice for cost effective full service fermentation of both aerobic and anaerobic microorganisms.
Our services in microbial fermentation for both bacterial and yeast strains include:
- Master and working cell bank preparation, validation and storage
- Fermentation and subsequent downstream purification
- Downstream processing optimisation and development
- Multiple feed strategies and media options
- Lyophilisation of live
LuinaBio has experience in working with many different types of Live Biotherapeutic Products and helped its customers to create a robust and controlled process, which gives the ability to move products through the various clinical phases towards commercial launch.
Our licensed facilities are prepared to meet preclinical to marketed production needs with fermenters ranging from 5L to 500L and the associated downstream processing working in cGMP. Our state of the art facilities include a series of modular clean room laboratories with ISO 8 fermentation suites and support areas, as well as ISO 7 clean rooms for purification and final product isolation suites. Raw material, In-process and finished product storage areas in our cGMP compliant facility range from -80°C to controlled ambient temperature. These facilities are supported by cGMP compliant QA and QC services.