Compared to traditional drug delivery techniques in animal healthcare, microspheres offer a host of benefits, including an extended duration of action, better bioavailability, and improved active pharmaceutical ingredient (API) palatability.
But it can be difficult to bring microspheres-based animal health products to market. Notably, their development is fraught with setbacks to overcome, such as API-excipient compatibility or drug-loading difficulties.
A contract development and manufacturing organisation (CDMO) can guide you through the complexities of bringing a microspheres-based treatment to market. By partnering with a CDMO, you can reduce the risk, time, and costs associated with microspheres development and manufacturing, and get your product to market quicker.
In this article, we talk about three key reasons to partner with a CDMO for your programme — quickly confirming feasibility, simplifying regulatory compliance, and accessing necessary expertise and infrastructure. It’s important to flag, though, that not all CDMOs are equal. For tips on how to choose the best CDMO partner for your programme, download our eBook.
- Confirm feasibility quickly
In drug discovery, failing early is critical to minimise unnecessary costs and resource usage. But it can be challenging to recognise any fail-early indicators if you do not have the necessary expertise in microspheres.
A suitable CDMO partner will have extensive knowledge and experience in microspheres development, regulatory submission and manufacturing, allowing them to identify any programme-halting concerns early on. For example, they will be able to identify any incompatibility between APIs and target species, and know which microspheres carriers and excipients are likely to work with a given API.
Further, as mentioned in our earlier blog post, exploring drug-loading potential is vital in early development, but can be challenging to do without the appropriate experience. A CDMO will be equipped with the tools, technologies and expertise to explore drug-loading potential, helping them determine whether microspheres technology is suitable for the API under investigation.
- Simply comply with regulations
The regulatory landscape for microspheres-based therapies can be difficult to navigate for those just venturing into it. To help you, some CDMOs will have a dedicated regulatory affairs team, allowing them to confidently advise on requirements, limitations, and pitfalls with microspheres development and dossier creation.
Additionally, unlike first-time developers of microspheres-based treatments, CDMOs have a wealth of experience from previous programmes to draw on, helping them anticipate regulatory questions, queries, and requests. As such, they can significantly strengthen the application, making it more likely to get rapidly approved.
- Access necessary expertise and infrastructure
As your project moves further through development, you will have to scale up your manufacturing. But many organisations do not have the infrastructure or the expertise to do so simply. A CDMO with microspheres experience, on the other hand, will have the ready-built facilities and experience needed to easily transition from lab scale to commercial scale production.
What’s more, the CDMO will have optimised process parameters and a validated cleaning method. As such, they can ensure there is no carry-over contamination, which substantially lowers risk, time, and costs for this stage of development.
Streamline microspheres development with the right partner
Not all labs have the right in-house knowledge, experience, and infrastructure to overcome the challenges of bringing a microspheres product to market. By partnering with an expert CDMO, you can access the expertise you need for smooth, rapid, and successful product delivery.
However, the breadth and depth of capabilities can widely vary from CDMO to CDMO. To maximise your chances of success, you should consider a number of factors when choosing your partner.
To discover what makes a good CDMO partner and accelerate the path to market for microspheres-based treatments, download our eBook today.
