Forge Biologics

Scaling AAV manufacturing without sacrificing quality? It’s possible. For gene therapy developers navigating the complexities of scale-up and regulatory expectations, FUEL™ is more than a platform—it’s a strategic advantage. Built by AAV experts, FUEL™ combines advanced technologies, cGMP-proven processes, and tailored optimization packages to reduce development risk while accelerating timelines. Whether you're solving upstream bottlenecks or preparing for pivotal milestones, our platform helps you achieve the efficiency, consistency, and compliance your program demands. Explore our full capabilities here ➡️ https://bit.ly/41idL2s

🎉 Happy National Intern Day! This week, our brilliant class of nine interns is wrapping up their projects and gearing up for final presentations. From curiosity to creativity, they've brought energy, fresh ideas, and unwavering dedication to Forge's mission throughout their time here this summer. To celebrate their contributions, they hit up Top Golf with their managers. Thank you, interns, for everything you’ve brought to Forge this summer!

Scoops & Connections 🍦✨ This week, our women's employee resource group, She Forges, hosted a fantastic networking event designed to spark meaningful connections and promote professional growth — all served with a side of Graeter's Ice Cream!

🚨 ICYMI: 23 Questions with Lauren Hall!   We recently caught up with Lauren Hall, MS, PMP, a project manager on our PMO team, to learn how she keeps complex client programs moving forward and what she does outside of work to stay focused and inspired.   From SmartSheets tips to her favorite reads, Lauren gives us a behind-the-scenes look at her routines, priorities, and what makes her tick.   Catch her 23 rapid-fire answers here ➡️ https://lnkd.in/gj-qM4rj

Same product, different batch size. How does this affect my BLA submission? When it comes to filing your BLA,  comparability data  isn’t just a checkbox, it’s the gatekeeper to approval. For AAV gene therapies, consistency in potency, purity, and full/empty capsid ratio is non-negotiable. At Forge, we help you bridge the clinical-to-commercial gap with harmonized assays, in-house analytics, and deep regulatory know-how—so your product holds up, batch after batch. Read more about the BLA filing process here ➡️ https://hubs.li/Q03z6BND0

From Tokyo with innovation 🇯🇵💡 We’re heading home energized by the incredible gene therapy community at #JSGCT. It was an honor to share the week with our colleagues at Ajinomoto and connect with the inspiring developers from across Japan and APAC. Rachael Hardison, Ph.D., shared how our FUEL™ platform is helping gene therapy teams streamline manufacturing and bring their breakthroughs to patients faster. Here’s to continued collaboration!

Developers need a manufacturing partner committed to R&D to stay ahead of breakthroughs and help deliver more doses per batch—supporting more programs and reaching broader patient populations with greater efficiency. That's why in 2023, we published novel findings on the critical role of Ad L4 22/33k proteins in AAV manufacturing. These insights led to the development of our pEMBR™ 2.0 Ad Helper plasmid, now a foundational technology in our FUEL™ platform. Read our peer-reviewed article authored by Angela Adsero, Ph.D., et al., to see how we’re driving innovation in AAV manufacturing: https://hubs.li/Q03yLcSN0

👩🏾🔬 Get (Cleanroom) Ready With Me #GCRWM! Before the science starts, the suit up matters. Join GMP Technician Toi Crimley behind the scenes as she preps for a product changeover, an essential step that keeps our manufacturing suites compliant and client programs running smoothly. From primary gowning to sterile coveralls, see how our manufacturing support team helps protect the integrity of every AAV run with compliance, precision, and care. This isn’t your average #GRWM. It’s how we suit up for science that drives real-world impact.

Our FUEL™ AAV manufacturing platform can deliver more doses per batch, helping developers reach more patients. Hear what fuels our team as they power more productivity for our clients and the patients they serve. Fuel more: https://hubs.li/Q03y9cmy0

Whether it’s optimizing yield or advancing analytics, our team is tackling innovative AAV manufacturing strategies from every angle, and they’re bringing that expertise to Boston for the 17th Annual Bioprocessing Summit! Check out the AAV experts and their sessions below 👇 Esko Kautto, PhD, Ph.D., Senior Scientist Development of NGS Methods for AAV Characterization Tuesday, August 19 | 2:15 PM Danielle Sexton, Associate Director, Process Development Upstream Process Optimization: Using Design of Experiments (DoE) to Create Scalable Manufacturing Processes and Improve AAV Yields and Quality Wednesday, August 20 | 10:40 AM Keerthana Subramanian, Associate Director, Process Development Downstream Process Optimization and Scale-Up for AAV Production Thursday, August 21 | 10:30 AM Frank Agbogbo, Ph.D., Vice President of Process Development Chairing: Advances in Viral Vector Production session Thursday, August 21 | 7:55 AM Let us know if you’ll be attending. We’d love to connect. https://hubs.li/Q03y2hgg0