Elektrofi, a biotechnology company focused on drug formulation and delivery innovations, announced a strategic contract manufacturing agreement with Thermo Fisher Scientific to support clinical manufacture of Elektrofi’s breakthrough ultra-high concentration subcutaneous products.
Elektrofi’s platform technology is designed to overcome the challenges of delivering biologic-based therapies by enabling patients to self-inject therapies at home rather than in a hospital setting. Based on strong preclinical validation and partner interest, the company expects to initiate multiple clinical trials in 2024. The collaboration with Thermo Fisher will facilitate the establishment of a platform cGMP line, scheduled to be operational in early 2024, that will support early clinical efforts across a wide variety of pipeline programs and enable rapid scale-up for late-stage and commercial development.
“We are eager to begin investigating our subcutaneous delivery technology in human clinical trials to explore how it can positively impact the healthcare space, both by easing the burden on patients and caregivers and by improving therapeutic outcomes,” said Chase Coffman, CEO and Co-Founder of Elektrofi.
“To successfully initiate clinical development, we need to establish certified cGMP manufacturing capabilities. We’re thrilled to partner with Thermo Fisher, a global leader in development and manufacturing, to meet this goal and continue advancing our efforts to change the way biologic-based drugs are delivered.”
High-dose protein therapeutics are mainly administered through intravenous infusion due to formulation limitations at high concentrations. Elektrofi’s proprietary microparticle technology enables small-volume injections for biologics such as monoclonal antibodies, therapeutic proteins and other large molecule drugs that are of growing importance to human health due to rapid innovation in the biopharma industry. This technology helps overcome the need for patients to get treated at hospitals or infusion centers, a process which requires time and supervision from healthcare professionals, and has potential to drive significant positive change for patients.
“Our expertise in drug development and manufacturing will help Elektrofi pioneer a significant advance in how medicine is introduced into patients,” said Leon Wyszkowski, President, Commercial Operations, Pharma Services for Thermo Fisher Scientific. “We deeply appreciate their confidence in us and look forward to the clinical research progress we will make together.”
