Elektrofi Announces Collaboration with Thermo Fisher Scientific to Strengthen Manufacturing Capabilities for Future Clinical Trials
Collaboration will establish a platform cGMP line to support Elektrofi’s planned clinical trials of injectable biologics
BOSTON, Feb. 07, 2023 (GLOBE NEWSWIRE) — Elektrofi, a biotechnology company focused on drug formulation and delivery innovations, today 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.”
Elektrofi is a biotechnology company focused on improving administration for a wide range of medicines including monoclonal antibodies, therapeutic proteins, and other large molecule drugs. Its breakthrough formulation platform enables stabilized, highly concentrated formulations for subcutaneous administration. The company is using this technology to transform therapies that are administered intravenously, and to enhance injectable products by reducing the volume and frequency of dosing. Elektrofi partners with pharmaceutical companies to jointly develop patient-friendly delivery solutions. Headquartered in Boston, the company is shaping the future of biologics delivery. For more information, visit www.elektrofi.com or follow us on Twitter and LinkedIn.