AdAlta Limited (ASX:1AD) has executed a Master Services Agreement (MSA) establishing CTPL as AdAlta’s preferred manufacturing partner of cellular immunotherapies.
This agreement provides AdCella, AdAlta’s cellular immunotherapy collaboration with SYNthesis BioVentures (SYNBV), with key product development, manufacturing and supply chain capabilities.
CTPL will support AdCella in delivering AdCella’s objective of providing innovative cellular immunotherapies originating in Asia with access to AdAlta’s i-body technology and a pathway to western regulated markets.
Under the MSA, CTPL and AdAlta have agreed to work together on each product that AdCella may in-license, subject to certain limitations and conditions related to capability and commercial competitiveness. CTPL will provide a range of services, including process development, technology transfer, analytical testing, clinical product manufacturing and supply, and regulatory support. The MSA establishes service standards, governance mechanisms and customary terms related to commencing and ending projects under the MSA.
"This collaboration with CTPL is the next key building block in our strategy to bring highly innovative cellular immunotherapies into a western regulated environment,” AdAlta CEO and Managing Director, Dr Tim Oldham, said.
“CTPL’s demonstrated expertise over many years and multiple clients ensures that we will have access to the skills, experience and facilities needed to realise this goal, and importantly that we can immediately demonstrate this to our in-licensing partners. "
The financial costs and timelines of each project will be set out in individual Work Orders to be agreed as required and are not anticipated to be material prior to AdCella securing rights to its first assets. Initial work under the MSA is anticipated to include Technical Feasibility Assessments of AdCella's in-licensing candidates. The Technical Feasibility Assessments will evaluate the suitability of these products for manufacturing at CTPL under both Australian and US regulatory frameworks and will provide AdCella with critical data to support its in-licensing decisions. Should the results of Technical Feasibility Assessments be satisfactory and if AdCella successfully in-license any of these product candidates, AdCella and CTPL will work together to transfer manufacturing processes into CTPL facilities and manufacture patient doses for Phase I clinical trials.
