The answer has significant strategic implications for every stage of the product’s development cycle and manufacturing process, from the first clinical batches and regulatory submissions, to Phase 3 scaleup and market authorization, to the product’s lifespan. Product stability – and any steps that must be taken to protect it – is a critical component of both the clinical and commercial profile of any injectable medication.
Of course, this question also begs another – how do you know which strategy you need for ensuring your product’s long-term stability, and which dedicated stability program will allow you to put that strategy into action?
As you formulate your drug product its substance class will provide you with the information on how stable or not it is at room temperature.
Certain groups of molecules have well-known, readily identified stability limits. Several examples include:
- Large molecule biologics, such as proteins, antibodies, and peptides
- Lipid nanoparticles
- Viral vectors
Products based on molecules like those often degrade at room temperature, and thus require additional steps to ensure they remain stable. If your molecule falls into one of these groups, your development team may be able to quickly determine that similar stability considerations may apply. If your product is part of an established or well-characterized substance class, or a biosimilar, related or precedent products can give you a clear indication of which stability strategy may be best for your molecule.
If your drug substance doesn't have comparable products already launched in the market, stability studies conducted during preclinical development will often be the first indicator of any stability limits that may affect a future drug product.
If your product is not stable at room temperature or at 2 to 8°, you need to consider other methods to stabilize the product for long-term storage. For most injectable drug products, the answer is one of three well-established methods – each with its own benefits and drawbacks. Here’s a closer look at each one.
In our clinical manufacturing video series, Dr. David Brett, Product and Service Manager at Vetter, discusses each of the three options as well as three key considerations to keep in mind when creating a smart strategy:
- Target markets. The stability plan will depend on whether your company is supplying to many different countries in various scenarios.
- Distribution channels. Is the product going to be widely distributed? This also affects the strategy.
- End-user resources. For example, are there settings where the cold chain isn’t a given? This is critical in determining the best stability plan.
It is also important if the company is considering licensing out the product. Putting a stability strategy in place may add value to the product and enhance future deal potential.
Even if a company is not planning on licensing, choosing the correct approach to stabilizing their product can have a big impact on its market profile.
Interested in more drug stability insights?
Did you find this CDMO Insights post helpful? Dr. David Brett speaks in depth about creating an optimal product stability plan in a how-to video on the Vetter Video Hub. Sign up today to stream this feature and more – including insights on planning your clinical batch and complying with cGMP in your early-stage filling projects.