Thermo Fisher Scientific, a leading biotechnology company, recently provided expert insights into its new media and feed system, Gibco™ Efficient-Pro™ Medium and Gibco™ Efficient-Pro™ Feeds 1 and 2, in an interaction with BioPharma APAC. The interview delves into the features and benefits of its next-generation monoclonal antibody (mAb) manufacturing solution, designed to help improve CHO-based cell culture performance. The interview also highlights how the Gibco portfolio of CHO media and feeds can support optimal CHO cell culture and optimize the workflow for researchers and scientists.

Furthermore, Thermo Fisher discusses how it helps to ensure the quality and consistency of its media formulations and what measures are in place to enable this. Overall, the expert insights from Thermo Fisher provide valuable information to biopharmaceutical developers and manufacturers looking to enhance their cell culture performance and accelerate their journey to market.

• Can you provide a detailed overview of the new media formulations, Gibco™ Efficient-Pro™ Medium and Gibco™ Efficient-Pro™ Feeds 1 and 2, and their features?

The Gibco Efficient-Pro Medium and Feeds system is a next-generation mAb manufacturing solution from Thermo Fisher, designed to help improve CHO-based cell culture performance.

The medium and feeds system consists of an advanced, high-performance medium and two innovative, single-part feeds formulated specifically for use in key bioproduction cell lines. Feed 1 is designed for use with CHO-K1 and CHO-K1 GS cells, and Feed 2 for use with DG-44, CHO-S, and CHO-K1 GS cells.

Through using an advanced multi-omics and bioinformatics modeling approach, the formulations were developed to help improve process performance through sustaining optimal culture health and cell viability, as well as lower levels of toxic metabolite production [1]. The formulations of both the medium and feeds are chemically defined and animal origin-free, helping manufacturers maximize batch-to-batch consistency.

While both the medium and feeds can deliver improvements individually, the great performance benefits can be gained when used together—either as an off-the-shelf solution or a starting point for further customization. Overall, by using the basal medium alongside the appropriate feed for their chosen cell line, the system can help manufacturers maintain strong titers and potentially improve product quality [1].

• How do these new media options differ from the existing ones and what are the benefits for cell culture performance?

The Gibco Efficient-Pro Medium and Feeds system represents an innovative new approach to CHO cell-based mAb production. Recognizing the need for continued improvements to mAb manufacturing productivity, this solution can boost cell culture performance while also streamlining processes. Ultimately, these factors can help developers reduce costs and accelerate their journey to market.

When using the Efficient-Pro Medium with either Feed 1 or Feed 2 (depending on the cell line), it is possible to achieve up to 238% greater titers and up to 180% greater specific productivity compared to products from other media suppliers [1]. Furthermore, through improvements in culture health and cell viability, manufacturers can maintain longer production runs of up to 17 days, enabling greater productivity from existing processes with limited re-optimization.

Moreover, the Efficient-Pro Feeds have been designed as single-part solutions, facilitating simpler reconstitution and feeding, and ultimately requiring fewer external components. As they are also nutritionally-complete, balanced formulations, manufacturers can use up to 50% less feed volume per manufacturing run. They are also stable at room temperature, which can limit precipitation and reduce the need for feed line flushing or replacement during the traditional 14-day bioproduction process.

• Can you explain how the complete collection of Gibco™ CHO media options can support optimal CHO cell culture?

The Gibco portfolio of CHO media and feeds includes a wide range of options for maximizing cell culture performance across many bioprocessing applications and cell lines. All solutions within the portfolio have been designed to deliver exceptional cell culture performance off-the-shelf, while also offering substantial ease-of-use benefits. As a result, our catalog solutions can not only enable manufacturers to optimize process productivity, but also help reduce development time and accelerate speed to market.

• How do these new media options support Gibco™ High-Intensity Perfusion (HIP) CHO Medium and Gibco™ ExpiCHO™ Stable Production Medium (SPM)?

The Efficient-Pro Medium and Feeds system is the latest addition to the Gibco portfolio of CHO media solutions, which includes the Gibco High-Intensity Perfusion (HIP) CHO Medium and Gibco ExpiCHO Stable Production Medium (SPM). Taken together, these solutions can offer a high level of flexibility for developers working on CHO-based bioprocesses.

The breadth of the portfolio gives developers a multitude of options, enabling them to choose a solution that meets the unique requirements of their process. For example, the Gibco HIP CHO medium is designed for use across the complete range of perfusion processes, offering a chemically defined, animal origin-free solution that can deliver high titers all while using less medium. Moreover, for developers working with ExpiCHO-S cells, the Gibco ExpiCHO SPM is an end-to-end workflow solution, designed with scalability in mind.  

• What makes Gibco™ CHO media a high-performing option for cell culture and how does it optimize the workflow for researchers and scientists?

Every product in the Gibco CHO media and feed portfolio has been designed for use as a ready-to-use workflow solution that can fit seamlessly into existing processes and optimize yields, product quality, and process efficiency.

They are available in a range of formats, including liquid, dry powder (DPM), and Thermo Fisher’s proprietary Gibco™ Advanced Granulation Technology (AGT™) format. The AGT format is designed for rapid dissolution and is pH and osmolality preadjusted, which can simplify reconstitution by speeding up media preparation and help reduce time and labor costs compared to traditional dry media.

Furthermore, with its extensive knowledge and expertise, Thermo Fisher can provide developers with in-depth support to help them choose the right product and implement it within their process.

• How does the company ensure the quality and consistency of its media formulations and what measures are in place to guarantee this?

Thermo Fisher reliably delivers high-quality, consistent media products to biotherapeutic developers and manufacturers across the world. With its comprehensive global network of media manufacturing facilities, Thermo Fisher can offer robust supply assurance and consistent product quality, ultimately enabling developers to maximize confidence in their processes.

To help maintain the consistency of media formulations, Thermo Fisher has established an in-depth global equivalency program, which is implemented at all sites within its media manufacturing network. This program includes harmonized capabilities across four key pillars: raw materials sourcing, equipment, manufacturing processes, and finished product testing.

Raw material harmonization includes a global qualification process for raw materials and suppliers, which helps ensure that equivalent raw materials are used at every facility. When it comes to harmonizing equipment and manufacturing processes, this means all equipment and validation processes are equivalent at all sites, and that manufacturing procedures, validation protocols, and employee training processes are consistent across the network. Lastly, finished product testing harmonization is achieved by utilizing equivalent quality assurance (QA) and quality control (QC) testing equipment, methods, cell lines and specifications.

• How does the company plan to continue to innovate and expand its product portfolio in the future to meet the evolving needs of cell culture researchers?

Thermo Fisher is constantly evolving its capabilities, using the latest innovations to deliver industry-leading solutions for customers looking to elevate their processes. This includes leveraging artificial intelligence, machine learning, and best-in-class instrumentation to support next-generation analytical capabilities, such as advanced bioinformatics and multi-omics.

Thermo Fisher uses these technologies to gain in-depth insights into intracellular processes and pathways, facilitating the development of cutting-edge media designed to deliver optimal cell culture performance. Additionally, Thermo Fisher continues to be an industry leader in scalability, automation, and continuous manufacturing, making use of its depth and breadth of expertise to continue to support the transition to Biopharma 4.0.

[1] Thermo Fisher Scientific (2022) Efficient-Pro Medium and Feeds improve productivity in CHO-K1, CHO-S, and DG44 cells. http://assets.thermofisher.com/TFS-Assets/BPD/Application-Notes/efficient-pro-medium-and-feeds.pdf