Solutions for Cell and Gene Therapy
The success of a cell or gene therapy is critically dependent on the quality and efficacy of the therapeutic product. Cell culture media is an often overlooked critical raw material that can directly impact the therapeutic potential and success of your therapeutic cells. Learn how to expedite, optimize, and even save money with our unique portfolio of products and services.
Solutions for Every Stage of Your Development
Including comprehensive services, innovative digital platforms, pre-optimized reagents and media, and cutting-edge instrumentation, our solutions help facilitate a quicker path to commercialization with early optimization, ownership, and the quality necessary to lower regulatory hurdles.
Research and Development
Early-stage development is fast-paced and rapidly evolving. Final formulations are being iterated, and defining the components that drive the performance of your cellular model is crucial. Due to the rapid pace, ready access to cost-effective, GMP cell culture media, supplements, buffers, and balanced salts is necessary.
Research and development products and services
- Physiologix XF GMP serum replacement
- NB-ROC T Cell SF medium
- NB-AIR cloud-based media designer
- NB-Lux online media and solution configurator
- Krakatoa point-of-use pod-based media maker
Process Development
Process development requires the fine-tuning of conditions and protocols to find the optimal process for your therapy. During this stage, formulations are optimized for performance, de-risked, and analyzed for downstream scalability.
Process development products and services
- NB-AIR cloud-based media designer
- NB-ROC T cell SF medium
- Expert-guided Formulation services
- NB-Lux online media and solution configurator
- Comprehensive GMP services
- Physiologix XF GMP serum replacement
- Krakatoa point-of-use pod-based media maker
Pre IND
As cell and gene therapy products move into the later stages of development, formulations, protocols, and processes are locked down. At this stage, steps are taken to ensure a smooth path to regulatory approval, looking ahead to process scale-up and the need to increase process volumes to full manufacturing levels.
Pre-IND products and services
- Physiologix XF GMP serum replacement
- Reagents including buffer and balanced salt solutions
- NB-Lux online media and solution configurator
- Comprehensive GMP services
Clinical Trials and Manufacturing Scale-Up
Timely supply of the appropriate quantity of raw material is of the utmost importance to ensure trial and manufacturing runs operate as quickly and efficiently as possible with minimum waste. This is especially challenging for cell and gene therapy products where the viability of living cells must be considered and timing becomes crucial. Acquiring optimized custom cell culture media in a timely fashion becomes even more important.
Clinical trials and manufacturing products and services
- Physiologix XF GMP serum replacement
- Reagents including buffer and balanced salt solutions
- NB-Lux online media and solution configurator
- Comprehensive GMP services
The Nucleus Biologics Advantage for Cell and Gene Therapy
Take control of your media and accelerate your cell and gene therapy program. Our team has the experience and expertise to guide your cell culture media needs and the innovative tools to speed your discovery to cure.
Accelerate Your Research
Speed and flexibility are critical to bring your research to the clinic and, oftentimes, off-the-shelf media can feel like the only viable solution. However, each component in your media can contribute to experimental variability, thus, it is crucial to know each ingredient and concentration in order to optimize your media to best meet your performance goals. Easily customizing your media and owning your formula IP can have significant downstream impacts and make media your competitive advantage.
Iterate for Optimization
Iteration in small volumes reduces cost and waste, and allows for the rapid identification of an optimal formulation before scaling. Quickly search peer-reviewed articles to extract a list of high-value components and their effect on cell performance with NB-AIR. Add, remove, or adjust components through NB-Lux and test variations to find the optimal composition for your application. Or, take a more hands-off approach and let our team of media experts design a formula that meets your specifications from start to finish.
Validate Your Process
Prepare for scale-up by ensuring your process is delivering a consistent and reliable product. Partner with Nucleus Biologics to expedite your path to market, finalize and lock in your optimized formula (your IPs), manufacture your media or solution, and let our GMP services team do your validation and qualification heavy lifting. We can get you steps closer to commercializing your cell and gene therapy product.
Scaling Up
Manufacturing cell and gene therapy products require a reliable supply of often complex raw materials. In this environment, the desire to flex raw material lot sizes to match your dynamic production demands is important. NB-Lux is designed to scale with you. Easily adjust the lot size of your critical raw material as required in order to meet changing manufacturing schedules, ensuring a consistent and reliable supply of the raw materials needed to support the complex manufacturing process.
GMP Manufacturing Facility
When you partner with Nucleus Biologics, you can expect premium quality cell culture media products and services. With over 7,000 square feet of manufacturing space and 7 clean rooms operating under ISO 13485:2016-certified quality system, we leverage our scientific expertise with media development and GMP manufacturing to provide validation and development services aimed at delivering a specialized product that meets your stringent requirements.
Documents and Downloads
Become a cell and gene therapy media master. Review our helpful product information to learn how our products and services can accelerate your groundbreaking research.
NB-AIR™ Product Note
Learn more about how NB-AIR can help you formulate better-performing media.
NB-Lux™ Product Note
Learn more about NB-Lux and the benefits of customizing your media via this online media configurator.
Krakatoa™ Product Note
Review the technical details, features, and benefits of the Krakatoa media maker.
Need Help?
Get in touch with our customer support team for any questions you may have.
Visit NB-Lux™
See all available media products and customize according to your requirements.
Formulation Services
Get expert help in developing or optimizing your media to your desired characteristics.
Resources
Take your cell culture media mastery to the next level with our knowledge resources and learn how cell culture media can be a competitive advantage on your path to commercialization.
