Early-stage molecular diagnostics (MDx) companies that are focused on R&D have seemingly endless considerations to make such as: what supplier to purchase custom oligo probes from, how to select the most cost-effective option for assay components, and will their multiplex test or platform work.
Amidst the immediate and tangible research and development priorities, it is easy to overlook the broader, long-term objective that drives your entire team: How can we reduce the time required to bring our product to market?
One aspect in particular is often neglected: how will your product design (including essential components making up an assay) scale for manufacturing and commercialization?
Many MDx companies and their chosen suppliers can encounter problems regarding quality, batch-to-batch consistency, technology transfer, as well as regulatory compliance during preparation for large-scale manufacturing. Eventually, these problems can interrupt a product launch.
Fortunately, such future challenges can be anticipated and addressed in advance, and there is no time like the present. Companies can proactively avoid numerous common obstacles encountered during scale-up by partnering with a raw materials supplier well-versed in guiding laboratories through the intricate path to commercialization. 4 tips on mastering assay scale-up
This is not a decision that should be taken lightly. Selecting whom to buy enzymes, master mixes, or oligonucleotides from demands extensive research, vetting, time, and energy, which all detract from core tasks at the bench.
This guide outlines a streamlined approach for the selection of an experienced and trustworthy supplier for your MDx components. Investing time into thinking through these aspects of assay design and development early on, can save the difficulty of trialling new components in the later stages of product design, avoid the need for assay redesign, or save you time in researching and onboarding a new supplier during the chaotic manufacturing process.
Step 1: Assess your needs
Before even starting to consider suppliers, there are some fundamental questions that need to be answered before engaging with any potential vendors.
After reading this section, you should be able to:
- Understand the current supply requirements for your team
- Appreciate how these requirements will change as you scale up for manufacturing
What do we need right now?
You may need a complex fluorescent probe for qPCR or a customized oligo synthesized with a proprietary modification. This can narrow down the list of potential suppliers to just one or two.
If a routine reagent is required, such as T4 ligase or standard oligo, then the decision is likely more difficult since there may be between 10 and 20 suppliers still in the running.
Defining exactly what you require upfront can help to streamline the decision-making process. If you already have a regularly scheduled weekly status meeting, dedicate a fraction of the meeting for the collection and refinement of your internal needs, asking questions such as the following:
- How much do we require of X?
- What price range is satisfactory for purchasing X?
- What level of QC/QA is required at this stage?
What will we require in the future?
If all goes well, your R&D will develop, manufacturing will become a reality, and regulatory approval will be within reach. However, you may decide to go to market as an RUO assay. Regardless of your market strategy, you will reach certain milestones, and your current requirements will change.
It can be challenging to anticipate what will be required in the future, but a rough approximation of what it may look like can help to raise awareness about some of the potential issues regarding scaling up that may arise and help to visualize where the work is going.
Understanding the long-term requirements will also help when it comes to communicating with any potential suppliers. This leads to the suppliers being able to better inform you of their capabilities and how they can support where you are going.
Meet with your internal team again, and be sure to include any members of the team who would be handling procurement, compliance, or technology transfer. They may also have expertise in the commercialization process and can assist with better refining what your future requirements will be.
Some further questions to guide this meeting could include the following:
- How much of X will be required for scale-up and manufacturing?
- What price range is satisfactory for securing the large-scale, manufacturing-grade supply of X?
- What standards will X need to be manufactured under?
- What costs are acceptable concerning scale-up and quality considerations?
- What quality management and control systems will we need to have implemented?
- Will our product operate as RUO or IVD designation?
- What regulatory agencies will be required to provide approval for our assay?
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