Media development for cell therapies can be a time consuming and costly effort, often involving testing of multiple formulas prior to selection. Some opt to select an off-the-shelf media option to save time and streamline development. However, additional customization to these formulations is often difficult because they involve proprietary formulations. In addition, cell therapy companies frequently include media composition as part of their intellectual property portfolio, which isn’t possible with an off-the-shelf formulation.
Another option is to create a customized media; this frequently requires combing the literature for publicly available formulas and then customizing to suit an individual process. However there isn’t an easy way to see the effect custom media configurations have on pricing and custom media formulations can frequently take up to six months to manufacture.
In recognition of a clear need in the industry Nucleus Biologics recently launched NB-Lux™, an online configuration, ordering, and tracking platform for custom cell culture media. The platform was designed specifically for cell and gene therapy and vaccine developers to streamline and simplify custom media formulation. The platform provides real time pricing for cGMP grade media in lot sizes from two liters to 2,000 liters.
Users can optimize each individual chemical component and concentration, testing requirements including USP methods, and packaging including bags and bottles. By customizing a media to the unique critical attributes of each therapy, developers can take control of formulations, rapidly progress from small- to large-scale production, and move therapies to the clinic faster. In addition, larger organizations can assign Super Users and Sub Users with individual access permissions to protect the intellectual property of the formulas. This feature allows the platform becomes a management tool for the company’s IP. Nucleus Biologics is also testing a Beta AI functionality where users can select cell types, critical quality attributes, and get feedback on the components to select for their formulations. This feature is based on peer reviewed publications.
Ordering Custom Media is Simplified with Consumer-based Interface
In looking for myself, I was impressed by the interface, which is very straightforward to use and mimics what one is used to seeing on consumer-based retail websites.
You begin the customization process by choosing what you would like to customize. The options are media, buffers and balanced salt solutions, cryo media, or you can click to access Nucleus Biologics’ formulation services.
As part of my test drive, I selected media customization. Next, I had the option of customizing by searching for the base media using cell type, keyword or manufacturer catalog number. I selected cell type.
After selecting cell type, I was provided a list of cell types to choose from. I selected MSCs, which then generated a 21-page list of media to choose from to begin my customization.
I selected the first in the list, DMEM from Corning. This took me to a page that contained all pertinent details about the selected media, along with menus for additional customization.
Here, I have the ability to select the media format and testing options that I would like and the order quantity and packaging.
Next, I am given categories from which to select further customization – amino acids, vitamins, inorganic salts, proteins, cytokines and growth factors, nucleotides and other components are all on the menu.
One of my favorite features is that as you make changes and select different options, in the upper right portion of the screen is a window that is updating the predicted osmolality, price per liter and total price in real time.
In speaking with David Sheehan, Founder, President and CEO of Nucleus Biologics, about why they created the NB-Lux platform, he said “Our mission is to speed the time from discovery to cure. We listened to the frustration of our cell therapy customers and reimagined the cell culture media configuration and ordering experience. No longer must a scientist guess what to add to proprietary, sole sourced medias or wait almost half a year to receive custom media.”
To try out NB-Lux, please see https://nblux.nucleusbiologics.com/home