SAN DIEGO, Oct. 24, 2022 / — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced the appointment of Charles Calderaro III as Chief Technical Officer. Mr. Calderaro brings three decades of manufacturing and engineering experience to Shoreline, with industry-leading expertise in building and optimizing technical and manufacturing infrastructures for cell therapy products.
“Chuck is a drug manufacturing expert, highlighted by the successful creation and implementation of end-to-end manufacturing and commercial operations for Kite, a Gilead company and a leading cell therapy company. I am thrilled to welcome him to Shoreline as Chief Technical Officer,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Co-Founder, Chairman and CEO. “With Chuck’s expertise and our iPSC platforms, we are well positioned to implement our planned scalable manufacturing approach, designed to reduce the cost and complexity of manufacturing and enable the development of true ‘off-the-shelf’ products for use in outpatient settings. This could lead to a significant competitive advantage as we move our iNKs and iMACs towards the clinic.”
Prior to joining Shoreline, Mr. Calderaro served as Global Head of Technical Operations for Kite, a pioneer in cell therapy development, where he was responsible for leading all aspects of Kite’s technical operations, including process development, CMC regulatory, manufacturing, quality, supply chain, engineering, and end-to-end optimization of commercial and pipeline products. While at Kite, Mr. Calderaro oversaw the manufacturing of CAR-T cell therapy products at commercial scale. Prior to Kite, Mr. Calderaro was Senior Vice President, Global Manufacturing at BioMarin Pharmaceutical, where he was responsible for the strategic oversight and leadership of a diverse international manufacturing network, which utilizes small molecule, oligonucleotide, biotechnology, and gene therapy technologies to deliver an innovative portfolio of clinical and commercial products to patients. Before that, he spent fourteen years at Genentech in roles of increasing responsibility in product management, engineering, and manufacturing. Early in his career, Mr. Calderaro spent time at Alcon, a division of Novartis, and at Aventis Behring, spanning roles in manufacturing, validation, and biopharmaceutical operations. Mr. Calderaro received a Bachelor’s degree, Electrical Engineering from the University of Notre Dame, a Master’s Degree, Nuclear Engineering from the US Naval Nuclear Power School and a Master of Business Administration from Texan Christian University.
“It is clear that a major gating factor to increasing the number of cellular immunotherapies on the market is the lack of automation in the manufacturing process. Shoreline’s smart manufacturing system holds tremendous promise to create a novel, scalable, end-to-end process, that will optimize the product quality of iPSC-derived cell therapies,” added Mr. Calderaro. “The strength of the technology and the team created a compelling opportunity for me and I look forward to creating the manufacturing system of the future, with the goal of finally winning the war on cancer and delivering benefit to patients.”
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.