Avaà Bio, Inc., an emerging biotechnology company developing cell-based therapies for diabetes, age-related disorders, and anti-aging, has announced – together with its joint venture partner and global biotechnology firm, Austrianova – a milestone in the company’s path to clinical trials, the completion of a master cell bank (MCB) of genetically modified cells that overexpress the α-Klotho protein.
Now, the MCB will undergo testing to confirm the absence of pathogenic viruses, as well as standard assays to verify the MCB is free from adventitious agents such as bacteria, mycoplasma, fungi, and yeast to meet regulatory expectations, including those set by the FDA. This will be conducted independently by a third-party provider, separate from Austrianova, Avaà Bio, and their combined joint venture, Klothonova. Following successful completion, the next step will be the generation of a working cell bank (WCB) using α-Klotho protein–overexpressing cells derived from the MCB. These cells will be used to manufacture the final Cell-in-a-Box encapsulated clinical product.
An MCB is a GMP-compliant, fully characterised, and homogeneous collection of vials derived from a single clone. It serves as the critical starting material for the scale-up and production of cell therapies, ensuring product consistency while reducing risk by protecting against contamination, degradation, extraneous agents, and genetic instability. By establishing and maintaining a high-quality MCB as the primary source for all WCBs under good manufacturing practice (GMP) standards, Avaà Bio and Austrianova said they are strengthening the foundation for a reliable, scalable, and sustainable supply chain.
This marks a significant step forward in Klothonova’s mission to develop a sustainable, cell-based approach to restoring declining levels of the α-Klotho “longevity protein” associated with aging. The approach is intended to address both general aging and age-related conditions, including kidney disease, neurodegenerative disorders, and vascular diseases.
“We are pleased that this first step in the production phase of α-Klotho producing cells has been successfully completed. We look forward to the completion of the subsequent steps needed to fulfil our commitment to deliver safe, effective treatments for the ever-burgeoning array of aging associated diseases,” said Chris Winter, CEO of Avaà Bio.
Brian Salmons, CEO of Austrianova, said: “The Austrianova team is pleased to have completed the production of the α-Klotho protein expressing cells on behalf of Klothonova, our Joint Venture with Avaà Bio. We look forward to completing the next steps that will culminate with the production of Cell-in-a-Box encapsulated clinical product for application to patients.”