"Early Investment in Your Media Strategy Will Pay Off in the Long Run"

Sartorius has recently expanded its cell culture media and buffer offering to better support drug developers across their complete production process. To share some of our expertise, we talked to Mayank Gupta, Product Specialist in Cell Culture Media. In the following blog post, Mayank provides some insights to help you optimize your CHO media development and shares how Sartorius delivers solutions throughout the media pipeline.

^{This article is posted on our Science Snippets Blog}

Media selection and optimization are critical in the lifecycle of the drug development process. Identifying the right basal medium and feed combination is important for achieving the maximum titer with expected product quality. You will also need to choose a reliable supplier who can provide high-quality products according to your needs.

In a conversation with Mayank Gupta, we discuss how you can create a media strategy for your protein production platform.

What challenges do drug developers face when developing a cell culture media strategy?

“The first challenge is finding the right combination of basal medium and feed to suit your cell line, whether a commercially available off-the-shelf media or a custom media created in-house or by an external partner. There is a huge range of specialty media on the market supporting different cell lines and applications, for example, media supporting cell culture for protein production using a CHO platform, or the culture of viral vectors using a HEK cell line.

It is certainly worth taking the time at this stage to screen multiple media types for effect on yield and product critical quality attributes to find opportunities for improvement.”

Employing a design of experiments (DoE) approach can significantly shorten timelines and improve experimental outcomes.

Mayank Gupta, Product Specialist in Cell Culture Media

That sounds like a long process…

“Depending on how you approach the screening process, it could take a significant amount of time to find the best medium composition and feed strategy. A substantial number of parameters can be adjusted within the screening experiment, and different components have complex relationships with one another.

However, employing a design of experiments (DoE) approach can significantly shorten timelines and improve experimental outcomes. A DoE strategy can help identify the optimal medium formulation (and process parameters) in fewer experimental runs than a one-component-at-a-time approach. Taking advantage of supporting software, such as virtual bioreactors, can generate accurate in-silico predictions to further reduce experimental runs.

Another way to simplify the selection process is to access a high-throughput screening or media development service from an external vendor.”

This screening would be done on a small scale. How can you ensure that the medium performs as expected when you transition to a large scale?

“Small-scale bioreactor systems – such as Ambr^® 15 – are fully scalable from the lab to commercial manufacturing. So, the medium that performs best at a small scale has a high chance of behaving similarly at production scale. Using such comprehensive, scalable tools can help streamline your scale-up process.”

Once you have found the right media and ensured the strategy is scalable, what other considerations are there for developing a media strategy?

“One important feature to remember is how your media preparation, storage, and feeding strategy affects the day-to-day running of your facility. To streamline the process, you will want media that is easy to prepare and handle. While liquid formulas offer ease of use, they are typically more expensive and require a greater storage area. In that case, you will want a high-quality powder formulation and simple hydration protocols to simplify preparation.”
 

    +       eBook - A Comprehensive Guide to Finding the Right Cell Culture Media

What about finding the right vendor?

“As well as optimizing the composition of the cell culture media, you also need to consider the qualities of your chosen supplier. Two important features to look out for are assurance of supply and how they can help you meet regulatory requirements.

Sartorius has recently expanded its media offering, providing a specialty media portfolio and feed supplements to support protein production and gene therapy applications.

Mayank Gupta, Product Specialist in Cell Culture Media

A media supplier should be reliable and agile. Look for vendors with dual raw material sourcing and a global manufacturing network to help deliver security in your supply chain. Your partner should also be able to demonstrate raw material traceability and strict quality control guidelines for a manufacturing facility and product release. This transparency will help simplify your regulatory submissions.”

Finally, can you tell us a bit about how Sartorius supports media development?

“Sartorius has recently expanded its media offering, providing a specialty media portfolio and feed supplements to support protein production and gene therapy applications. As well as this ready-to-use culture, we offer a range of flexible services that simplify your media journey and improve your product titers, including process development, cell line adaptation, and media optimization. Finally, Sartorius can perform spent media analytics testing to give you a broader picture of how your cell population uses the medium and what metabolites accumulate during the process.”