As the leading contract development and manufacturing organization (CDMO), we have signed a contract with Korean drug development specialist Liveome for the formulation, development and clinical manufacture of a targeted release formulation containing lyophilized microbial cells suitable for phase one clinical trials. The drug substance is being supplied by Australia-based Luina Bio.
“Starting with these CDMO contracts for LIV001, we plan to build a cell bank, develop a production process and produce clinical samples,” Liveome CEO Song Ji-yoon said. “We aim to complete a nonclinical toxicity test this year and start a global clinical trial by 2023.”
We were selected for the project because of our proven expertise in the product development and clinical supply of therapies derived from the microbiome, which includes not only microbes but also small and large molecules that require targeted delivery throughout the body. SGS is the leading CDMO licensed for the support of oral drug products manufactured utilizing live biotherapies. We offer a breadth of expertise in formulation development across many delivery routes, along with an understanding of isolation and containment techniques to protect the environment during the manufacturing process.
In particular, we have introduced procedures to effectively handle many types of microbes during the development and manufacture of drug products in order to maintain their potency.
“We are delighted to be working on this important project,” commented Commercial Operations Director, Maireadh Pedersen, of SGS’s Quay Pharma. “Our appointment by Liveome underlines not only our development and manufacturing capabilities in this significant new sector, but also our ability to deliver our services globally and continue to grow our support of the South Korean market.”
SGS’s advanced manufacturing facilities in Deeside, UK include a suite of laboratories with a compartmentalized design to containment level 2, enabling us to work on a variety of projects and different microbes simultaneously.
Established last year, Liveome, a subsidiary of Medytox, is a company specializing in the development of next-generation new drugs. It has two live biotherapeutic product (LBP)-related technologies – N-LBP, a natural microbiome-based platform technology, and E-LBP, which maximizes gene-editing treatment efficacy. Liveome is rapidly expanding its new drug pipeline for intractable diseases based on the two platforms.
LIV001 is a candidate for the treatment of inflammatory bowel disease, which has applied Liveome’s E-LBP platform technology. The drug has been designed to have maximized therapeutic efficacy by regulating immune function to ensure safety as a therapeutic agent.
Liveome has recently confirmed the therapeutic efficacy of LIV001 for acute and chronic enteritis through a preclinical trial.
SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 96,000 employees, we operate a network of over 2,600 offices and laboratories around the world.