As 2025 comes to a close, we want to take a moment to reflect on a year filled with progress, partnership, and meaningful impact across the cell and gene therapy community. At Nucleus Biologics, everything we do begins and ends with one mission: helping you bring life-changing therapies to patients faster, with greater consistency, transparency, and control.
This year, that mission came to life in more ways than ever before.
A Year of Innovation and Momentum
Raising the Industry Standard: The First Excipient-Certified Custom Media Provider
One of our proudest milestones this year was becoming the first custom media and reagents provider to earn EXCiPACT certification for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification. This certification is a globally recognized quality standard for excipient GMP manufacturing and reinforces our commitment to transparency, traceability, and manufacturing excellence. It gives customers even greater confidence that Nucleus Biologics products meet the rigorous requirements needed to support clinical and commercial therapeutic programs.
Read our blog: Accelerating Cell and Gene Therapy Development With Excipient GMP Quality Media and Buffers: The Nucleus Biologics Advantage
Chosen as a Long-Term Commercial Supply Partner for Cell Culture Solutions
This year also marked a major milestone in our commitment to supporting our customers through every stage of their therapeutic journey. We signed a long-term strategic supply agreement with a commercial-stage biotechnology company to manufacture all of the cell culture solutions supporting their cell therapy program, including expansion media, cryopreservation media, protein supplement, and all other bioproduction liquids.
This partnership reflects the trust developers place in Nucleus Biologics to deliver high-quality, Excipient-GMP solutions at commercial scale with the consistency and transparency required for global therapeutic supply and underscores our ability to support programs from early development through full commercialization.
Wash Your Hands, Not Your Cells: NB-KUL™ DF Delivers 54% Increase in Cell Recovery – No Wash Step Required
We shared new insights on NB-KUL DF cryopreservation medium, showcasing how T cells cryopreserved in NB-KUL DF achieved 54% average increase in cell recovery without washing when compared to CryoStor® CS10 (after the necessary washing step). This is truly game-changing – you remove a step while improving your final product yield and lowering your cost.
NB-KUL DF delivers:
- Superior cell recovery, with no extra processing needed
- Streamlined workflows that save time, reduce handling, and minimize variability
Contact our team to learn more about this data.
Launching FGF-2 TOP® GMP: The FIRST and ONLY GMP and Thermostable FGF-2 Expressed in Plants
A major highlight this year was the release of FGF-2 TOP in GMP grade. FGF-2 TOP GMP is the first and only GMP thermostabilized growth factor expressed in a novel plant expression system. Because it is produced using a proprietary plant-based expression system, it cuts costs in half and ensures high purity and sustainability while eliminating supply chain bottlenecks. Completely animal-free, it is a safer choice for cell and gene therapy applications.
This launch was a significant step in our commitment to helping developers build safer, more reliable processes for cell and gene therapy manufacturing.
Learn more:
- Optimizing Stem Cell Culture Conditions with Sustainably Produced FGF-2 TOP® GMP
- Plant-Expressed Recombinant Proteins: A Safer, Scalable, and Sustainable Solution for Cell and Gene Therapy
Want to try FGF-2 TOP? Complete the form on the product page to request a free sample*.
*One per customer, and you pay for this shipping.
Accelerating Custom Media Development: Expanding QuickStart Media™ With HEKima™ Suspension
This year, more Therapeutic Developers than ever relied on QuickStart Media to rapidly design, optimize, and manufacture custom formulations with full transparency. From early discovery to clinical readiness, developers used media from our QuickStart Media portfolio to reduce timelines, de-risk scale-up, and improve performance across a wide range of cell types.
And we’re just getting started! We expanded the QuickStart Media platform with the launch of HEKima™ Suspension, a next-generation HEK293 suspension medium designed for high-density growth and improved productivity. Built using the same principles of speed and transparency, HEKima Suspension will give viral vector and protein expression programs a powerful new tool to advance to the clinic faster.
Currently available formulations include NB-ROC™ T cell medium, NB-KUL™ 10 and NB-KUL™ DF (DMSO-free) cryomedium, HEKima™ Adherent HEK cell medium, and NB-MSC™ medium.
Read our blog to learn more: A Deep Dive Into QuickStart Media
Leading the Conversation: Sharing Industry Insights With Life Science Connect
This year, we also had the opportunity to share our perspectives with the global life science community through three featured presentations with Life Science Connect, each focused on the evolving demands of modern bioproduction and the critical role that optimized, GMP-ready media solutions play in therapeutic success.
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Quality By Design: Accelerate Development With Excipient GMP Quality Cell Culture Solutions
In this talk, we walked through how quality principles intersect with media and buffer development and why excipient-grade GMP components are essential for reducing variability and ensuring patient safety. The goal of this presentation is to help the industry rethink the role of media and buffers, adopt higher quality standards, and ultimately bring therapies to patients faster and more reliably. Watch the 15-minute webinar: Quality By Design: Accelerate Development With Excipient GMP Quality Cell Culture Solutions
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Is Your Media Silently Holding You Back? The Case for Optimized and Excipient GMP Cell Culture Solutions
In this session, we examined one of the industry’s most persistent challenges: unseen variability in media, buffers, and supplements. We highlighted how optimized formulations, full transparency, and excipient GMP manufacturing can dramatically reduce risk, improve reproducibility, and accelerate the path to the clinic. The discussion underscored how media and buffers, often taken for granted, can be a hidden bottleneck or a competitive advantage. Watch the webinar: Is Your Media Silently Holding You Back? The Case for Optimized and Excipient GMP Cell Culture Solutions
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Megatrends for Bioproduction Media and Buffers
This presentation focused on the forces reshaping the future of therapy manufacturing. In this session, we explored how regulatory requirements and cost pressures are transforming bioproduction, and why companies are moving toward custom, Excipient GMP-quality media and buffer solutions to accelerate their therapeutic development. Watch the 15-minute webinar: Megatrends for Bioproduction Media and Buffers
What We’re Most Proud of: Your Impact
Across hundreds of programs, developers pushed the boundaries of what’s possible in cell and gene therapy. Whether you were optimizing early-stage formulations or preparing for clinical translation, we were proud to be part of your journey.
Looking ahead in 2026, expect even more ways for Nucleus Biologics to help you reduce costs, accelerate timelines, and simplify your path to the clinic.
Thank You for an Incredible Year
Whether you collaborated with us on a custom formulation, a media optimization project, scaled your manufacturing, or joined us on a webinar, thank you.
We’re honored to be your partner, and we look forward to helping you move even faster in the year ahead.
From all of us at Nucleus Biologics, Happy Holidays, and here’s to a transformative 2026.
