Personalised culture media solutions support timely biopharmaceutical manufacturing

What are the clients’ goals in seeking out a personalised culture media solution?

Oftentimes, our clients’ goals are to increase cell growth, improve protein titers and optimise product quality attributes. Biopharmaceutical manufacturers find that custom media can provide tailored solutions.

What are some of the challenges manufacturers face?

One of the biggest challenges manufacturers face is lot-to-lot consistency. They need to resolve any issues that affect cell performance and quality, whether it is media optimisation or process improvement. They also want to produce larger quantities of viable media in a timely manner. By providing a personalised culture media solution we can help our clients understand the critical points in the manufacturing process and help facilitate their efforts to reduce risk and cost during late-stage development.

Having scale-up-ready media and processes is a big concern as well. As manufacturers move through the media development process to scale-up manufacturing, they must establish stringent quality guidelines for their media and processes in order to meet quality and regulatory standards.

How do you approach the process of developing customised media?

Initially, we examine the details of our client’s manufacturing process. A thorough review often reveals that the reasons clients fail to reach their goals lie with cell performance in the current media, or with their culture processes. Further discussion often exposes significant problems with lot-to-lot consistency with current media suppliers and scale-up to supply all their manufacturing sites globally. Our R&D team is happy to present custom media development and manufacturing options for our clients to consider, to meet these challenges.

What are some of the solutions FUJIFILM Irvine Scientific can offer?

One option could be a complete ‘fresh start’. Clients can survey a panel of animal component-free, chemically defined Chinese hamster ovary (CHO) media prototypes, supported by the FUJIFILM Irvine Scientific R&D team, to identify an optimal medium for achieving the desired improvements. Because these media are already available and well‑characterised, a quick assessment is possible. Additionally, the media have been tech-transferred for good manufacturing practice (GMP) manufacturing, which enables rapid integration into the manufacturing process.

However, some groups want to use their own current media as a starting point for further optimisation. A second option is to develop an entirely customised medium tailored to the group’s cells, application and therapeutic protein in a Media Development and Optimization (MDO) project. The MDO project can be performed at the client’s facility, in a self-serve capacity, using media developed and manufactured at FUJIFILM Irvine Scientific facilities in Irvine, California.

Lastly, if capacity or resources are the limiting factors, full-service media development and testing can be conducted at FUJIFILM Irvine Scientific facilities. Discussions with the client enables the right service to be selected for their needs.

How does a self-service MDO project satisfy the client’s requirements for custom media?

For groups wanting to participate in the development and verification process, the self-service MDO option is the ideal choice. We begin by assessing the requirements for productivity, manufacturing footprint, manufacturing time, and improved quality of the therapeutic protein.

Our R&D begins by designing a custom panel of cell culture media for small-scale screening, based on the clients’ current medium, followed by further optimisation of the top candidate media using a Design of Experiment (DoE) approach.

During the design process, spent media samples can be analysed for amino acids and nutrients to fine-tune the media based on the cells’ needs. Throughout the development process cell growth and viability are monitored and protein titer and quality can be assessed.

Finally, the media can be optimised for culture in bioreactors, with the goal of identifying several candidates for confirmation at the client’s site. The media can be rapidly manufactured through FUJIFILM Irvine Scientific’s non-GMP Express Media Service (EMS) to provide larger amounts of each formula for testing at the client’s site.

How can custom media be produced at larger scale for use at the manufacturer’s site?

Once an ideal candidate medium is identified, the cell culture media experts at FUJIFILM Irvine Scientific can help optimise the client’s cell culture process further. The process of ordering powder or liquid media from the FUJIFILM Irvine Scientific GMP facility is simple, economical and efficient for the client. A supply agreement for consistent, regular delivery of GMP media can be implemented, helping to address concerns regarding dependable supply for global manufacturing sites.

Are there any other programmes that can provide further optimisation of a client’s media process?

Sometimes, clients need support with improving and simplifying their media preparation process; for example, when clients have begun using a supplement to improve cell growth. This process can be laborious to integrate into the final medium, as well as cause issues with solubility.

To address these issues at the large scale of manufacturing, our experts in the Manufacturing Science and Technology (MSAT) Service can help clients by improving their existing medium. For example, MSAT can work with clients to integrate a supplement with an easier and faster preparation process and by modifying components to prevent precipitation.

The new, improved medium can then be manufactured in the cGMP facility and, once tested, it often forms one element in a holistic approach to optimised biopharmaceutical manufacturing. A platform medium across several applications requires robust growth and titer, and a medium that is easy and safe to prepare; thus, the design and preparation method for this custom medium is key.

What do you see as the main advantage of your Custom Media Services programmes?

Collaboration delivers consistent results. Through a collaborative partnership between FUJIFILM Irvine Scientific and upstream process development groups, a custom medium solution can be developed which improves cell yield, protein titer and product quality.

In addition, FUJIFILM Irvine Scientific’s media experts can help clients to increase productivity and efficiency of manufacturing, reduce costs and risks, and save time during late-stage development. The consistent delivery of high-quality medium ensures reliable, timely manufacturing and enables biopharmaceutical manufacturers to focus on delivering life-saving therapies.

FUJIFILM Irvine Scientific fully commits to being an integral part of its clients’ process to deliver high-quality biologic drug substances to biopharma manufacturers. It is a responsibility that ultimately builds good industry partnerships and long-term relationships that result in achieving high quality therapies.