The cell and gene therapy industry experienced unprecedented growth in 2024, marked by transformative advancements in technology, research, and clinical development. Key achievements included:
- Therapeutic Approvals: Several therapies for rare diseases were approved, including breakthrough treatments for hemophilia B.
- CRISPR-Based Gene Editing: Progress continued with CRISPR technologies, demonstrating potential to correct genetic diseases more precisely than ever before.
- Allogeneic (Off-the-Shelf) Therapies: The first wave of allogeneic CAR-T cell therapies began to showcase early clinical success, offering scalable and more accessible alternatives to autologous approaches.
- CAR-T for Solid Tumors: Researchers made strides in expanding CAR-T cell applications beyond hematological cancers, with promising response rates in traditionally challenging solid tumors like ovarian and pancreatic cancers.
- Increased Clinical Trials: The pipeline for cell and gene therapies grew rapidly, with hundreds of active clinical trials globally, spanning all phases of development.
Despite this remarkable progress, the field still faces challenges, particularly in pricing, manufacturing scalability, and ensuring global patient access to advanced therapies.
At Nucleus Biologics, we remain dedicated to addressing these obstacles by providing customizable and scalable solutions that simplify workflows, accelerate development, reduce costs, and ultimately improve patient outcomes and access. Below are some milestones the team at Nucleus Biologics achieved in 2024.
Revolutionizing Media Formulation with QuickStart Media™
At the forefront of our 2024 accomplishments was the launch of the QuickStart Media™ family, a portfolio of pre-optimized, customizable media solutions designed to give researchers a head start in formulating high-performance media.
Each product in the QuickStart Media™ family is engineered for specific cell types and applications, delivering exceptional scalability and flexibility for researchers while at the same time being fully customizable from components to packaging to meet our customer’s unique experimental and bioprocessing needs.
QuickStart Media™ Products Launched in 2024
- NB-KUL™ DF Cryopreservation Medium
A DMSO-free, chemically-defined, serum-free, and xeno-free cryopreservation medium designed to improve operational efficiency, enhance safety, and reduce patient risks. Download our white paper to review our comparative study. Click here to read our blog. - NB-KUL™ 10 Cryopreservation Medium
Specialized DMSO-containing cryopreservation media offering superior cell viability during freezing and thawing. Download our white paper to review our comparative study. - NB-ROC™ T Cell Serum-Free Medium
Designed for T cells, NB-ROC™ improves proliferation, transduction efficiency, and functionality to support CAR-T and immunotherapy research. - HEKima™ Adherent HEK Cell Serum-Free Medium
Optimized for adherent HEK cells, HEKima™ Adherent enhances proliferation, transduction efficiency, and virus production, reducing vector manufacturing costs for gene therapy applications. Download our white paper to review our comparative study. - NB-MSC™ Serum-Free Medium
A serum-free, xeno-free medium for mesenchymal stem cells (MSCs) that eliminates batch variability while enhancing proliferation and functionality, outperforming traditional DMEM + 10% FBS. Download our white paper to review our comparative study. Click here to read our blog.
Sustainable and Scalable FGF-2 TOP® GMP
In collaboration with Core Biogenesis, we launched FGF-2 TOP® GMP, a thermostable, sustainably-sourced recombinant protein. Designed to improve scalability and reduce costs, FGF-2 TOP® optimizes stem cell culture conditions while meeting the growing demand for sustainable solutions in cell therapy. This product is available as RUO samples currently and the GMP version will launch officially in early 2025!
Krakatoa™ Benchtop Media Maker Expands Globally
Our Krakatoa™ Benchtop Media Maker continued its global expansion in 2024, including an installation at the University of Central Lancashire (UCLan) in the UK. Elinor Whalley, Senior Laboratory Technician shared this incredible feedback:
“Since having our Krakatoa installed last July, we have seen significant improvements to lab processes. By using Krakatoa media, we have released huge amounts of fridge space previously taken up by media bottles. We have had no problem with supply chain delays and have saved time on orders by being able to make our own in-house media. Not only has time and space been saved, but our staff find the Krakatoa easy to use, and we feel particularly supported by the Stoic Bio and Nucleus Biologics team. The media itself has been brilliant, and cells grow very quickly and are in great morphological condition. On top of all these benefits, we have improved the sustainability of our lab, something as a team we constantly strive for. We are looking forward to continuing to work with the team and utilizing all the benefits the Krakatoa has to offer.”
This testimonial reflects how Krakatoa helps researchers simplify workflows, improve sustainability, and overcome supply chain challenges.
Custom AAV Buffers
We saw a significant increase in interest around custom gene therapy buffers to address the growing complexity of gene therapy manufacturing. Tailored buffers optimize downstream processing, reducing development time and improving therapeutic yields.
MediaVerse™: Digital Transformation for Media Manufacturing
We launched MediaVerse™, an internally developed electronic batch record system, to streamline media production and ensure compliance with 21 CFR Part 11. Benefits include:
- Faster lead times and QA turnaround.
- Real-time monitoring and comprehensive data capture.
- Digital documentation for enhanced traceability and customer satisfaction.
Looking Ahead to 2025
2025 promises to be another exciting year. We’re looking forward to:
- Expanding the QuickStart Media™ portfolio with new solutions for HEK suspension cells and NK cell research.
- Launching FGF-2 TOP® GMP to further support scalable stem cell therapy development.
- Receiving Excipient-Grade Certification allowing us to deliver even higher quality custom media, buffers, reagents, and other laboratory solutions to our customers.
Thank You for an Incredible Year
At Nucleus Biologics, we are proud to provide solutions that simplify cell and gene therapy development, reduce costs, and improve patient outcomes. Our innovations are not just products – they are bridges to life-changing therapies.
From all of us at Nucleus Biologics, thank you for your continued support. Please visit our website for more information about our products and services. We wish you a safe and happy holiday season, and we look forward to driving innovation together in 2025!
