Lonza has recently launched a new cell culture platform — the TheraPRO® CHO Media System. Can you tell us more about it? What are the key features and benefits, and how does it optimize the production of therapeutic proteins from GS KO CHOK1SV  cell lines?

The TheraPRO^® CHO Media System is a chemically defined animal-component-free cell culture platform designed specifically to support production of monoclonal antibodies (mAbs) and other hard-to-express proteins using GS CHO cell lines (one of the most prevalent therapeutic protein expression systems worldwide).

We crafted the platform to help biopharmaceutical developers and manufacturers better overcome some of the toughest challenges in biologics manufacturing — namely those involved with generating high-quality proteins at scale, quickly.

The end-user was kept in mind when developing the TheraPRO^® CHO Media System. As a result, customers can expect a number of benefits. First is exceptional ease of use and significantly simplified processes, brought about by the ready-to-use expansion and cloning media and the one-part production medium and one-part feed base powders for manufacturing steps. Users also get reconstitution instructions that remove the need for pH and osmolality adjustments or heat steps, further simplifying the process. With less complexity and fewer steps, manufacturers can reduce errors and speed up operations, helping them get their promising therapies to the patients, faster.

What’s more, the platform significantly increases the titer of high-quality proteins that end users can produce — as much as 5 g/L of high-quality protein during a 15-day manufacturing campaign.

And the benefits don’t stop there. The platform is highly versatile, too. For example, different biotherapy developers often use GS CHO cell lines exhibiting different metabolic states — cells that differ in terms of their growth and cell-specific production rates. But the TheraPRO^® CHO Media System has been demonstrated to support this diversity. What’s more, while the platform is optimized for use with GS KO CHOK1SV cell lines, it can accommodate an array of molecule types, including standard mAbs, complex proteins, or fusion proteins.

What specific attributes of the TheraPRO^® CHO Media System enable it to deliver an increased high-quality protein titer?

While we cannot divulge the technical details of the components and attributes behind this unprecedented performance, we can certainly share more about the expertise and approaches that make it possible.

First, Lonza has been doing this for a very long time. We have more than 30 years of technical know-how when it comes to cell culture media systems. That rich expertise and experience, combined with the most advanced technologies, design of experiments (DOE), and the high-throughput nature of our operations has allowed us to identify and optimize crucial platform components to deliver increased cell-specific productivity while maintaining cell viability, for the duration of cell culture. Ultimately, that’s what allows for the greater protein titer.

It's important to note that Lonza doesn’t just have the capability to design and create such high-performance platforms. We also have the capability to rigorously test and prove that performance, across an extensive range of scales. With the TheraPRO^® CHO Media System it’s no different — we’ve created a high-performance product, and we have a robust data package to back it up. That’s not always the case when it comes to media platforms available on the market.

Could you provide some insights into how the system can be applied throughout the cell culturing process? What kind of production volumes can it accommodate?

The TheraPRO^® CHO Media System is designed to provide an end-to-end cell culture media solution, and so is fully scalable from cell line development through to bioprocess manufacturing.

Each component of the system plays a key role in this scalability. The TheraPRO^® CHO Expansion Medium, for example, is utilized from the revival, subculturing, seed train generation, and cryopreservation steps onwards, while the TheraPRO^® CHO Cloning Medium is used for cloning steps, supporting the growth and viability of cells during a variety of cloning methods. The cloning medium is ideal for isolating clones, as well as supporting clone recovery during what can be a very stressful process.

Finally, the TheraPRO^® CHO Production Medium supports the high-density growth and viability of cells during the fed-batch production process, when used with the TheraPRO^® CHO Feed. Importantly, the TheraPRO^® CHO Expansion Medium is optimized to work with the TheraPRO^® CHO Production Medium to ensure a seamless transition from revival to production preparation.

We’ve thoroughly tested the TheraPRO^® CHO Media System in Lonza laboratories across a range of bioreactor types and scales. These include shake flasks and automated high-throughput bioreactors such as the Ambr^® 15 and the Ambr^® 250, 10L stirred tank bioreactors (STBRs), and single-use bioreactors (SUBs) up to 500L. Lonza has even modelled the performance of the TheraPRO^® Media System in stainless steel bioreactors as large as 20,000L.

The TheraPRO^® CHO Media System is chemically defined and free of animal components. What are the benefits to biopharmaceutical manufacturers in terms of regulatory compliance and product quality? How does Lonza ensure the chemically defined and animal-component free nature of the system?

A chemically defined medium with no animal components is the gold standard for biopharmaceutical manufacturers and has several advantages. Most importantly, a medium that is devoid of inherently variable animal components can offer greater lot-to-lot consistency, which means customers can benefit from more reproducible and reliable cell culture results. Animal component free media also eliminates the risk of contamination with adventitious agents or compounds that could hinder culture and protein production, leading to safer, more consistent, and more productive protein manufacturing.

Chemically defined, animal component free cell culture systems are also more regulatory friendly. To further assist with regulatory submission, Lonza can also, upon request, provide TheraPRO^® CHO Media System customers with a Drug Master File (DMF), as well as consultative regulatory support.

While chemically defined, animal component free media have clear benefits, manufacturing such products in a consistent manner is no easy feat. It demands robust quality control covering all aspects of raw material sourcing, processing, and manufacturing, as well as meticulous supply chain management.

At Lonza, we operate to the highest standards of quality control and embed excellence into all aspects of our manufacturing procedure. We have a global quality system in place that ensures we comply with the latest applicable FDA, ISO, and GMP requirements across all of our global manufacturing sites, and which adheres to ISO 9001:2015 and ISO 13485:2016

Importantly, we have a strong and robust supply chain that ensures we can continue to produce our high-quality products without interruption. With multiple manufacturing sites, and the ability to transfer manufacturing between them, we can further mitigate supply and production risks.

Given the complexity of manufacturing high-quality biologics, what kind of technical support and expertise does Lonza offer to customers using the TheraPRO^® CHO Media System? How does Lonza assist in troubleshooting and optimizing the production process?

As mentioned earlier, Lonza has extensive expertise and technical know-how when it comes to cell culture processes. As a company, we are responsible for the production of a vast array of large molecules and that arms us with considerable process knowledge and insight that we can use to help our customers be more successful.

From the get-go, we provide TheraPRO^® CHO Media System customers with the scientific protocols and guidelines to streamline their production processes, and provide guidance, tips and tricks as needed to get them up and running as swiftly and efficiently as possible.

Given the extensive testing of the system, and its demonstrated utility across a range of molecules, cell line metabolic states, and production scales, users should experience superior performance right out of the box. But if customers do encounter any challenges, our subject matter experts — and even the formulation developers themselves — are on hand to guide them to success.

We know that troubleshooting can be costly, both in terms of time and money. That’s why we’ve designed the TheraPRO^® CHO Media System to be as user-friendly as is possible.

Ensuring product traceability and lot-to-lot consistency is crucial in biopharmaceutical manufacturing. Could you elaborate on Lonza's ISO 13485 certified facilities and the quality control measures in place to maintain the highest standards in the manufacturing process of the TheraPRO^® CHO Media System?

As mentioned earlier, Lonza operates at the highest industry standards of quality control. All our facilities are ISO 13485:2016 certified and maintain a stringent quality management system. That way, we can ensure that our products meet customers’ exacting requirements in terms of quality and consistency, as well as adhering to stringent regulatory requirements.

What’s next for Lonza when it comes to cell culture media offerings? Where can readers find out more about the new TheraPRO^® CHO Media System?

Lonza is committed to enabling a healthier world by helping its customers to deliver new and innovative medicines to market. The TheraPRO^® CHO Media System is one part of that journey. But the journey is dynamic, and we know the importance of continual innovation and advancement. As such, we have a host of new cell culture media products in the pipeline, each designed, like the TheraPRO^® CHO Media System, to deliver superior functional performance coupled with ease-of-use — each designed to help customers overcome the biggest roadblocks on their route to biotherapy success. There’s a lot to be excited about.

Readers can find out more about the TheraPRO^® Media System on our website, or they can always get in touch with one of our knowledgeable cell culture experts via phone (+1 800 521 0390) or email (scientific.support@lonza.com).

.