Key Considerations When Outsourcing Cell-Culture Medium Development - The authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium con


Key Considerations When Outsourcing Cell-Culture Medium Development
The authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium consumer.

BioPharm International Supplements
Volume 24, Issue 3, pp. s15-s18

Well-defined project structure

Figure 2. A knowledgeable medium-development partner will help sponsors identify and set goals and priorities.
While scoping the technical aspects of a project to develop cell-culture medium, one needs to outline the project structure in parallel. Within the project structure, one needs to determine the amount of laboratory work that will be performed in-house versus outsourced, identify any critical performance steps that need end-user verification, and agree upon norms for joint team decisions. Also to be considered is whether the project has a time-critical element (such as the need for Phase II manufacturing in six months), as the technical strategy will be affected by how much experimental time can be dedicated to the project. For example, the sponsor may choose a sequential two-level study design followed by a central composite design of experiments (DOE) to pick the optimal medium formulation if the project can extend to 10–11 months; however if the sponsor has only three months, the project would more likely be designed following a single integrated basal medium or feed study to improve performance beyond current baseline (5). In each of these examples, having a knowledgeable media-development partner will allow the parties to set goals and priorities (see Figure 2).

Figure 3a. Life Technologies's media-manufacturing site in Grand Island, New York.
Beyond project specific decisions, performing the appropriate due diligence on a potential outsourcing partner's business processes is crucial. In particular, sponsors should inquire about success rates, functional roles within the project team, program management, and how the service provider manages crucial project decisions. Such "outsourcing best practices" are beyond the scope of this article, but are discussed in depth by several other authors (see, for example, the article by Douette et al. in this supplement). Most authors on this topic agree that a strong program-management infrastructure and proven track record are essential to minimizing the risks of outsourcing process development (6).

Medium supply terms

Figure 3b. Life Technologies's media-manufacturing site in Inchinnan, Scotland.
Thinking about medium-supply terms at the outset of a medium-development project might seem premature, but addressing certain concepts at this phase will make the overall process smoother. A medium-development partner that has thought through supply issues, and preferably has an established plan for commercial medium supply, will have a long-term advantage as the project proceeds. One difficulty in addressing supply terms at the outset of a medium-development project is that since the final product does not yet exist (because the medium is still to be developed), any terms should be flexible enough to handle unexpected outcomes or changes in the overall project scope or design. In most cases, a supply agreement should include pricing tiers by volume based on annual forecasting and a common set of quality standards. In recent years, as the biopharmaceutical industry has become more focused on risk management, many companies have begun to seek additional safeguards against an extended interruption in culture media supply. Most suppliers will present redundancies within their manufacturing operations as an assurance of continuity of supply (see Figure 3a and 3b), and direct any additional safeguards to be outlined within a supply agreement. In general, it is a good strategy to ensure that the general supply concepts are covered and save the final details until the development program is complete.

Intellectual property ownership

"Lifting the veil of secrecy." "Breaking the code." Such phrases may sound like a plot for a 1920s movie, but in fact these expressions describe a challenge faced by every cell-culture scientist charged with improving bioreactor productivity while being blinded to the composition of the medium used to culture the cells. Historically, improvements in medium performance were primarily reimbursed to developers through profits on media sales, which led vendors to maintain successful innovations as trade secrets to recoup their R&D investment.

Despite this history, visibility to the composition of cell-culture media formulations is becoming a priority as the field becomes further specialized and therapeutic companies become more focused on product life-cycle management. As a result, the parties should discuss the level of knowledge-sharing about the composition of custom media in any outsourcing negotiation. Typically a project sponsor will desire disclosure of a medium formulation for regulatory and further internal development purposes, while the developer will be concerned about protecting intellectual property and freedom to operate. One standard approach is for the developer to maintain ownership of the medium formulation and contractually define end-user rights to the intellectual property. Often, such intellectual-property terms can be linked with supply-agreement terms that address everyone's business interests. Experienced outsource providers will have thoroughly thought through these issues and can offer helpful guidance on what is best practice as it relates to a specific project.

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