DNA Therapeutics Electroporation Device

A biotechnology company focused on developing DNA-based therapeutics partners with Meddux to develop a delivery system for First-In-Human Clinical Trials.

Customer Need

A preclinical biotechnology company pioneering a DNA-based platform technology for delivering antibody and protein therapeutics sought to develop a Minimum Viable Product (MVP) delivery system to advance their First-In-Human (FIH) clinical trials. The system leverages electroporation to optimize targeted delivery of gene therapy across cellular membranes. Initial requirements encompassed user-centered design and product development of a reusable electro-mechanical handpiece paired with single-use sterile cartridges. Subsequent phases required custom process development, complex supply chain management, and timely delivery of devices for GLP animal trials and FIH clinical trials.

Process

Solution

User-centered design including task analysis, usability refinement, and workflow analysis enabled the Meddux team to generate multiple handpiece and cartridge concepts. Through concept refinement, prototype design, and formative studies, the team selected a final design to deliver a concept report and prototyping plan that met the customer's primary objective of gathering clinical data via a handpiece and cartridge design leveraging mechanism-driven injection coupled with therapeutic energy delivery.

The subsequent design and development phase encompassed detailed design engineering and tooling development under the Meddux Quality Management System. This phase culminated in the successful delivery of prototype devices specifically engineered to support critical GLP animal studies, functional benchtop testing, sub-system validation, and thorough integrated system-level performance testing.

Following successful completion of the GLP animal study, Meddux executed comprehensive Design Verification and Validation protocols for both handpiece and cartridge systems, including sterilization validation studies, shelf-life stability testing, biocompatibility assessments, and performance validation testing. This resulted in the timely delivery of validated sterile product ready for deployment in the customer's First-In-Human clinical trial.

Value Delivered

The innovative combination of reposable and single-use devices leveraged Meddux's core competencies in mechanical design, energy delivery systems, and process development. This partnership enabled the customer to concentrate their resources on advancing their breakthrough DNA-based therapeutics while Meddux handled the complex device development. Meddux assembled a team to collaborate closely with the customer, delivering the specialized expertise and quality necessary to position them to execute a successful clinical trial.

Meddux has been a great partner to work with.

— President and Chief Scientific Officer, Biotechnology Startup