In the first installment of this two-part blog, contract assay development was defined as “the outsourcing of assay development.” In that blog, we outlined the benefits of outsourcing.
In this installment, we’ll discuss some of the challenges inherent to using a contractor for product development. We’ll also suggest some strategies for dealing with those challenges.
Many organizations claim to be able to do contract assay development. They will point to their own product lines or lists of publications as evidence that they know how to develop assays. They are, for the most part, correct: they can develop assays in those circumstances and for those purposes.
The requirements for developing assays for another organization’s purposes, however, are quite different. If you want an assay for a short-term research project in your own labs, then an academic laboratory with a track record evidenced in a series of publications may be a good choice as an outsourcing partner. On the other hand, if you want an assay that can be manufactured reliably over years on a scale sufficient to supply customer laboratories around the world, choosing an academic lab to do the development is probably not a good idea. This is simply because most academic labs have no experience in large-scale production over an extended period of time. This means that they will most likely not understand the importance of such considerations as having reliable sources of critical raw materials such as antibodies. A polyclonal pool that is sufficient for 50,000 tests may sound like a lifetime supply to an academic group, but a commercially successful assay can burn through that in just a few years or less if the assay is successful. Having a monoclonal is one solution to this supply issue, but if care is not taken to establish master cell banks, working cell banks, and clone repositories in off-site locations, the product developed might be just one extended power failure from being off the market for months—or from having to essentially redevelop the product with a new monoclonal. Again, this will not be part of the skill set of most academic labs.
Working with commercial organizations that have developed their own products can solve many of these issues. They will understand what it takes to develop and manufacture assays and keep them in the market. If they did not have those skills, it’s unlikely that they would still be in business.
There is a subtle difference in developing products for your own organization and developing products for another organization, and it has to do with focus. If an organization’s primary focus is its own product line and contract development is just an adjunct activity, there is a built-in potential for conflict. All immunoassays need periodic tweaking and adjustments. The need for optimization can be a previously unseen variability in some raw material, or an advance by a competitor that suddenly threatens the viability of a key product line. In either case, it will be an unforeseen emergency that will require scientific and managerial resources to resolve the issue. Adjunct activities such as contract development for another organization will be deprioritized, and development timelines will begin to slip.
The best solution is to select an outsourcing partner whose sole business model is focused narrowly on contract assay development. If they have been in business for a number of years, it is likely that they will have a list of satisfied clients who are willing to make it known that this organization has developed products for them. The clients may not want the CAD partner to disclose which assays were developed for them, and that is understandable from a brand projection standpoint. That said, it is often possible to find joint publications or presentations on the assay by the contracted organization and its clients. If the contract organization does not have such a list of satisfied clients, they are either just starting out in the business (which is not a disqualifier, since everyone must start somewhere) or they did not satisfy the expectations of prior clients. In any case, the lack of a verifiable track record is a red flag that may indicate increased risk.
Once an outsource partner has been selected, the next step is to get a comprehensive contract in place that defines the roles and responsibilities of both parties. If the partner has been in business for several years, they will most likely have a standard development contract that they will have used with a number of clients. This is an excellent starting point, especially if the client organization is new to contract development. It does not mean that the client company should accept every term in the contract without thoroughly understanding it and having it reviewed by legal counsel. The process includes pushing back on the partner and crafting terms better suited to the client’s needs. The negotiations will also provide a clearer understanding of the outsourcing organization’s flexibility and willingness to work with the client. A contract is also no substitute for understanding that the only successful partnership is a win/win for both parties. If either party to the contract attempts to take unfair advantage of the other, mistrust and resentment will wreck the relationship in spite of what the contract says. Successful relationships develop multiple assays over years, not just one.
Assay development projects typically last 15–18 months (or longer) from inception to product launch. As in most human activities, communication is vital to the success of the project. Weekly teleconferences with the project developers and the client’s scientific, marketing, regulatory, and (especially) manufacturing representatives are the norm. An agenda for the meeting should be published by the contractor in advance of the scheduled meeting. Action items with names responsible for the action should be developed before the meeting ends and circulated to both the contractor and client organization’s respective management. Written monthly progress reports should supplement the weekly teleconferences. Quarterly face-to-face meetings in both facilities by key development team members are an excellent way to build common understanding and personal relationships. This is especially true of the manufacturing environment in which the assay will be manufactured over time. R&D is an interesting and necessary component of assay development, but if the product cannot be reliably manufactured, nothing else matters.
It must be understood that no product was ever developed without problems and mistakes. These are the inevitable result of the exploratory nature of immunoassay product development and the humans that carry out this process. While there are commonalities in assays, it seems that every time a new assay is developed, there is something new that must be learned and dealt with. This novelty means that new solutions will need to be explored. The reality is that some of them will not work. Finger pointing and Monday-morning quarterbacking do not build the teamwork needed to solve the problems at hand and the issues that will arise with the next assay.
For all the issues inherent in contract assay development, a successful practitioner of the process will be able to develop more products more quickly and with better allocations of resources than their competitor. They will also likely develop some professional relationships with colleagues in the partner organization that are deeply satisfying and that will expand their world.DCN Dx is an international leader in the contract development and commercialization of rapid diagnostic tests at its ISO 9001:2015 and EN 13485:2016 certified facility in Carlsbad, Calif. The company’s team of in-house scientists and engineers develop and integrate all aspects of assay systems, including cassettes, sample handling devices, and reader systems. Since its founding more than 12 years ago, DCN Dx has been committed to furthering the rapid diagnostic test market through the continued evolution of technologies and applications related to lateral flow assays.Contact us about your assay development project today.
