Every journey to contract manufacturing is unique. Some biotech companies know, at the start, they want to work with a contract manufacturing organization (CMO), while others choose to engage a CMO later in the product design process or even after production has started. While flexible providers will accommodate companies at any stage of their process, when is the right time to select a biotech contract manufacturer? Examining the pros and cons of early, late, and post-production engagement reveals the best time to select a biotech contract manufacturer.
Selecting a biotech contract manufacturer early in development offers the most comfortable timelines. While quicker than establishing in-house capabilities, contract manufacturing still requires lead-time prior to production. Documentation, tech transfer, and engineering runs can take months to complete in some cases. Regulatory needs may also be a factor. While most materials can be procured quickly, sufficient time should also be allowed for any long lead-time materials to arrive. By selecting a biotech contract manufacturer early, companies are comfortably able to navigate most hiccups without delaying the product launch.
Select a biotech contract manufacturer early to comfortably navigate most hiccups without delaying the product launch.
Despite the timeline advantages, is it possible to engage a CMO too early? For production, contract manufacturers need clients to provide the final bill of materials (BOM) and work instructions for their project. The finalized state of the BOM and work instructions are termed “locked.” Before the BOM and protocol are locked, documentation cannot be completed and materials that are procured may be a risk. If changes are required, the company will be forced to perform document change orders and possibly scrap the pre-ordered materials. For this reason, some CMOs may decline to finalize documents or order materials until the entire project has been locked.
However, in our experience, it still makes sense to select your CMO partner even if your project is far from being finalized. Engaging as soon as general requirements are known allows the CMO to forecast your tentative production timelines, and they may be able to assist with design for manufacturability (DFM) analysis or engineering runs. If you have a rough BOM, work instructions, and production forecast, you have enough to begin contacting potential CMOs.
Engaging as soon as general requirements are known allows the CMO to forecast your tentative production timelines.
A project further along in the development process has specs that are near-final or already locked, which brings a different set of pros and cons. Selecting a biotech contract manufacturer late in your development phase means that tech transfer activity could begin immediately, although the tradeoff is timeline flexibility. Transferring a project later in development means less delays for change orders, but it also means less available time to complete the entire manufacturing start-up process before launch. CMOs can strategically run advance procurement in parallel with tech transfer to overcome a late start. Materials with longer lead-times can be ordered at an earlier phase in the process with minimal risk, since the BOM will already be locked.
Transferring a project later in development means less delays for change orders, but it also means less available time to complete the entire manufacturing start-up process before launch.
One major drawback to contacting a contract manufacturer late in development is that product specs are nearly or completely locked by the time they are reviewed by a CMO’s manufacturing specialist. In some cases, the CMO’s technical operations team might uncover processes that are not conducive to manufacturing at scale. These hurdles can include labor-intensive manual steps, small batch processes, raw material availability, QC/QA requirements, and other bottlenecks. Consulting with a CMO earlier would have allowed identification and alternatives of bottlenecks before lock-in.
Consulting with a CMO earlier would have allowed identification and alternatives of bottlenecks before lock-in.
If you are already manufacturing your product, it is not too late to select a biotech contract manufacturing organization. There are many reasons why a product already in production might need to be transferred. Perhaps your popular product lines have outgrown internal manufacturing capabilities, a sunset portfolio is tying up valuable resources, or an existing CMO partner is not meeting your needs. While timelines on these projects are tight to avoid overlap of manufacturing expenses, they are often the most streamlined and have highly favorable outcomes. With locked product specs and existing manufacturing documentation, the project onboarding process is usually rapid.
While timelines on these projects are tight to avoid overlap of manufacturing expenses, they are often the most streamlined and have highly favorable outcomes.
As a biotech contract manufacturer, Argonaut has worked with companies in early and late development stages as well as organizations with products in active manufacturing. In our experience, all of these strategies can successfully work with a biotech contract manufacturing organization. Early projects have the most flexibility around timelines, late development projects are more prepared for tech transfer, and projects in production already have a working process in place to hand over. No matter where you are in the project lifecycle, now is the right time to engage a CMO.
In our experience, all of these strategies can successfully work with a biotech contract manufacturing organization.
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