One Year Strong: Reflecting on Growth, Momentum, and What’s Ahead at Genezen

As we close out 2025, we’re proud to mark an important milestone for Genezen: one year since the acquisition of our Lexington, MA commercial viral vector manufacturing facility. What began as a strategic expansion in July 2024 has become a defining chapter in our company’s growth — strengthening our capabilities, our partnerships, and our impact across the cell and gene therapy ecosystem.

This anniversary is more than a date on the calendar. It’s an opportunity to reflect on what our teams have accomplished together and to share how we’re positioning Genezen for the future.

A Strategic Step Forward

The Lexington acquisition marked a pivotal moment for Genezen. With the addition of a commercially capable, state-of-the-art facility, we expanded our end-to-end offering — supporting clients from early research through late-stage and commercial viral vector manufacturing under one organization.

Over the past year, our teams worked seamlessly to integrate the Lexington site into Genezen’s broader network alongside our Indianapolis operations. From site validation and readiness to onboarding active client programs, the focus has remained consistent: execute with excellence, maintain regulatory rigor, and deliver for our partners.

Scaling Capabilities with Purpose

Since July 2024, Genezen significantly expanded its manufacturing footprint and technical capabilities at both sites:

• Increased capacity for multiple viral vector modalities, including AAV in Lexington, and lentiviral, retroviral, and oncolytic virus in Indianapolis
• Support for both suspension-based and adherent manufacturing systems
• Upgraded cleanrooms, QC laboratories, and digital quality systems

These investments were made with one goal in mind — ensuring our clients’ programs are designed to scale efficiently while meeting evolving regulatory expectations.

“I am amazed at the tremendous growth we’ve experienced here…we’ve made numerous improvements, we’ve modified the facility footprint to accommodate multiple customers simultaneously, we’ve also included many pieces of new equipment to allow us to operate across different production scales and modalities.” – Scott Hemphil, VP & Lexington Site Head

In addition to the Lexington acquisition and site enhancements, our Indianapolis site also scaled to support new customers, including multiple GMP clinical-stage batches such as a Phase III retrovirus program. Our Process Development teams in Indiana have been full steam ahead to get these programs ready for GMP, leveraging our existing standard vector manufacturing processes and establishing tech-transferred client manufacturing processes.

Investing in People and Culture

Behind every milestone is a team committed to making it happen. Since the acquisition, Genezen has grown from 45 employees to almost 300 across our Lexington and Indianapolis sites.

This growth reflects deliberate investment in manufacturing, quality, process sciences, and leadership roles, while fostering strong collaboration across sites. Even as we scale, our culture remains rooted in Genezen’s CURES values: Commitment to scientific excellence, Urgency for patients, Resilience and grit in operations, Executing with excellence and integrity, and being Solutions-driven for our partners.

“We deliver a truly unique value proposition to our customers. Not just because of a deep technical expertise, and a commercial facility that is very unique. But it’s how we do things, and it’s how we live those CURES values.” – Steve Favaloro, Chairman & CEO

Hear more from Steve in his recent BiotechTV interview:

This year, we were recognized org-wide with two separate awards: a BioSpace Best Place to Work and as a Great Place to Work Certified™ company. These awards are the result of our commitment to our people, our culture and to serving patients.

Advancing Client Programs and Partnerships

Over the past year, we’ve had the privilege of partnering with leading innovators across a wide range of therapeutic areas, including rare disease, oncology, and CNS disorders. Highlights of our new partnerships include:

• Strategic supply agreements supporting  uniQure’s clinical portfolio and CSL’s commercial HEMGENIX®  program
• Being named a preferred partner to  Eli Lilly through their Lilly Catalyze360 program
• cGMP manufacturing support for  Optieum Biotechnologies’  lentiviral vector used in a novel CAR-T therapy for glioblastoma
• Process transfer and cGMP manufacturing of a recombinant VSV construct for  Humane Genomics’  pediatric liver cancer program

These programs underscore the value of continuity — supporting clients from development through commercial manufacturing while minimizing risk during critical transitions.

We also remain committed to our parent-foundation partners and are thrilled for the milestones achieved this year and new programs that have come on board with us. Some of these programs include:

• CMC expertise to support Elly’s Team for development of analytical/ancillary studies for an AAV9 gene replacement therapy targeting Neurodevelopmental Disorder with Regression, Abnormal Movements, Loss of Speech, and Seizures (NEDAMSS).
• CMC support to SLC6A1 Connect and we participated in Science Day as part of their annual symposium. Amber Freed’s son Maxwell (8) made history in September when he became the first patient to receive treatment for SLC6A1.
• We are proud to continue conversations and provide guidance to our partners at NF2 Biosolutions in the development of a treatment for Neurofibromatosis Type 2.
• We’re looking forward to sharing details in the New Year about our exciting project with the Charlotte & Gwyneth Gray Foundation for a treatment for Batten’s disease.

These partnerships underscore our dedication to the rare disease community and further demonstrate our CURES values. It is our sincere mission to partner with foundations like these and grow with them as they advance from early-stage trial to commercial treatment.

Looking Ahead

As we enter the next phase of growth, our focus remains clear:

• Continued investment in capacity, automation, and digital integration
• Expanding partnerships with biopharma innovators worldwide
• Anticipating regulatory expectations and industry needs — not just meeting them

Above all, we remain driven by a single mission: helping our partners bring potentially life-changing gene and cell therapies to patients with confidence.

“Every one of our 300 employees acts with urgency to get these medicines to market with a sense of resilience and grit that you need within biopharma manufacturing.” – Steve Favaloro, Chairman & CEO

Thank you to our employees, clients, and partners who have made this year since the acquisition such a meaningful success. We look forward to what we’ll achieve together in the year ahead.