THE NEXT GENERATION IN MEDIA DESIGN
As mentioned earlier, optimizing the upstream manufacturing process in terms of quality, predictability and consistency is
dependent on all process materials and affected by supplier and customer relationships.
The importance of these relationships and the desire for the supplier of media supplements to address customer needs has seen
the development of specialized media optimization services. Such services allow suppliers to work in conjunction with media
development scientists to gain a better understanding of how various supplements and feeds function in different cell culture
Media optimization services allow confidential information to be shared between the supplier and customer under specified
agreements. This arrangement provides transparent opportunities in media enhancement strategies such as chemically defined,
animal-component free, and serum-free media (SFM) optimization for individual applications. Solutions can be quite creative
and cost-effective when such collaborative approaches are adopted and long-term relationships are forged. In some cases, a
perpetual service agreement is enacted to allow for continued technical support and service. This value-added service can
result in dramatic advances in productivity and consistency.
For example, studies examining the benefit of adding various supplements in the Sheff-System to either a commercially available
SFM or the basal medium, DMEM, demonstrated a significant effect on CHO cell productivity. Supplements were tested at both
the low and high recommended concentrations. Increases in product titer were observed in all supplemented cultures with increases
almost 5-fold greater for SFM supplemented with a chosen supplement (see Figure 8a) and up to 10-fold in the supplemented
basal medium (see Figure 8b).
Figure 8: Low and high recommended concentrations of Sheff–CHO products were supplemented in two types of basal media, SFM4CHO(a)
or DMEM(b), and total productivity (solid) and specific productivity (Qp, hashed) measured. Increases in product titer were
observed in all supplemented cultures.
Close customer relationships also provide an opportunity for suppliers to recognize evolving requirements and concerns in
process and product development, improve existing systems, and develop new solutions designed specifically for cell culture
and vaccines clients.
In an attempt to lower production costs, and improve time to market while increasing product output, the biopharmaceutical
industry is looking to streamline production processes. Media-development strategies are a constant area of focus with simplification,
predictability, and consistency of upstream processes as major goals.
The response to industry requirements has seen major advancements in areas of cell culture media design with respect to supply
of specifically designed supplements and feeds. In addition, trends towards incorporation of QbD principles across the entire
manufacturing process has meant drug manufacturers are looking to raw material suppliers to provide quality products that
are fit for purpose.
Media and supplement system suppliers are also moving towards specialized performance optimization services, allowing for
the transfer of information freely between supplier and customer to develop specific media formulations. These custom-designed
products and services can not only provide manufacturers with enhanced upstream process performance but also have the potential
to reduce process timelines and time to market.
Sally Grosvenor is a freelance writer and science communicator.