Forge Biologics

“In the current state, facilities aren’t inspected until the market application is submitted… there’s a lot of opportunity here.” The FDA recently convened a meeting with 30 CDMOs to explore earlier engagement and strengthen U.S.–based biologics manufacturing. Our own Christopher Shilling was one of just 30 manufacturers invited to participate on the panel, representing the gene therapy industry. Chris also shared Forge’s perspective and key insights with Fierce Pharma, highlighting the importance of early collaboration between the FDA and manufacturers to advance innovation and ensure quality in gene therapy production. 🔗 Read the full article and get his insights here: https://hubs.li/Q03Q1qSh0

When it comes to connecting Forge with Ajinomoto’s global initiatives, Masahito Kuroda (Masa) plays a vital role in building bridges that drive innovation. As part of Forge's Client Development team, Masa helps identify new opportunities in Japan’s gene therapy space helping to bring global collaboration to life. Outside of work, you’ll often find Masa exploring the Columbus Zoo with his family, reminiscing about his tropical fish tanks back in Japan, or getting lost in a sci-fi novel like The Three-Body Problem. Learn more about Masa here ➡️ https://hubs.li/Q03PR-mY0

Our featured AAV case study demonstrates how early assay design turned initial production runs into powerful learning tools. Early developers often ask, “How do I define QTPP and CQAs when I have so little insight into my product or process?” The answer starts with a preliminary QTPP that outlines the intended characteristics of the therapeutic, paired with early CQA targets to guide assay design. By testing early batches with a focused panel of assays, including a phase-appropriate potency assay, teams can begin linking process parameters to potency and consistency, refining CQAs with real data and building a foundation for process control and cGMP readiness. Explore more in our article: Where do I start and will it work? ➡️ https://hubs.li/Q03PJFtc0

Making more—and testing it better. Forge performs 30+ in-house assays, from rcAAV to mass spectrometry, to enable efficient and accelerated characterization and release. Learn more: https://hubs.li/Q03Pt7xJ0

Press play on discovery and stay curious! Subscribe to Forge on YouTube for lab life, 23 Questions, and more ➡️ https://hubs.li/Q03PkVyq0

🔬 Hiring Spotlight: Senior Associate Scientist, Downstream Process Development Are you ready to play a hands-on role in advancing gene therapy manufacturing? We are seeking a Senior Associate Scientist to help develop and refine the downstream processes at Forge. In this role, you’ll be deeply involved in vector purification and process optimization, from culturing and transfection to harvest, lysis, and purification using techniques like FPLC and density gradients. You’ll also help maintain critical equipment and materials, ensuring our labs operate at the highest standards of quality and compliance. Your contributions will directly impact our mission of enabling access to life-changing gene therapies. Learn more & apply here ➡️ https://bit.ly/4nUVilZ

Step inside our QC lab with Allison Creech as she calibrates the osmometer, a critical tool that helps us verify the safety and quality of every AAV product, all under one roof! #GLRWM #QualityInAction

We know how important early molecular design decisions are for long-term manufacturing success. That’s why our team created this AAV developer checklist for GOI and rep/cap plasmids. It's a simple tool you can use right away to reduce risk and keep manufacturability in focus. Download your copy: https://bit.ly/496Krk9

As one of only 30 CDMOs in the room, Forge joined discussions on how the FDA and industry can engage earlier to enable more efficient U.S. manufacturing of biological products. Christopher Shilling and our regulatory team break down important takeaways for AAV developers: a shift from inspection to partnership, decoupling facility readiness from product review timelines, establishing clearer mechanisms for early FDA engagement, and more. 🔗 Read here: https://bit.ly/4q5Zb96

In honor of Breast Cancer Awareness Month, we were grateful to welcome guests from the Susan G. Komen Foundation to speak with She Forges, our women’s employee resource group. Their stories and insights inspired meaningful conversation around early detection, prevention, and the power of community support in the fight against breast cancer.