PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|February 13, 2023
Elektrofi Establishes Contract Manufacturing Agreement with Thermo Fisher Scientific
Author(s)Pharmaceutical Technology Editors
The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.
Advertisement
On Feb. 7 2023, Elektrofi, a biotechnology company focused on drug formulation and delivery innovations, announced a contract manufacturing agreement with Thermo Fisher Scientific to support the manufacturing of Elektrofi’s ultra-high concentration subcutaneous products.
The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting. The new collaboration will facilitate the establishment of a platform current good manufacturing practice (CGMP) line and is scheduled to be operational in early 2024. This is intended to support early clinical efforts across a 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, in a press release. “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.”
Elektrofi’s proprietary microparticle technology enables small-volume injections for biologics, like monoclonal antibodies or other large-molecule drugs. The technology is intended to help overcome the need for patients to get treated at hospitals or infusion centers.
“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 of Commercial Operations, Pharma Services for Thermo Fisher Scientific, in a press release. “We deeply appreciate their confidence in us and look forward to the clinical research progress we will make together."
Source:
Advertisement
Related to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
2
FDA's IND Pilot Puts CMC Review First
3
Spray Drying Capacity Signals Faster Paths for Poorly Soluble Drugs
4
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
5