Contract development and manufacturing organization (CDMO) SGS Quay Pharma has signed a contract with Korean drug development specialist Liveome for the formulation development and clinical manufacture of a targeted release formulation for the treatment of inflammatory bowel disease 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.”
 
SGS Quay Pharma was selected for the project because of the company’s proven expertise in product development and clinical supply for therapies derived from the microbiome, which includes not only microbes but also small and large molecules that require targeted delivery throughout the body. Quay is licensed for the support of oral drug products manufactured utilizing live biotherapies. The company’s expertise in this area is based on its breadth of expertise in formulation development across many delivery routes, along with its understanding of isolation and containment techniques to protect the environment during the manufacturing process.                                                                  
 
In particular, Quay has 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 SGS Quay Pharma’s commercial operations director, Maireadh Pedersen. “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.”
 
Quay’s advanced manufacturing facilities at its Quay House facilities in Deeside, UK, include a suite of laboratories with a compartmentalized design to containment Level 2, enabling the company to work on a variety of projects and different microbes simultaneously.
 
Established last year, Liveome, a subsidiary of Medytox, specializes in the development of next-generation new drugs. It recently confirmed the therapeutic efficacy of LIV001 for acute and chronic enteritis through a preclinical trial.