On the heels of Akron Biotech’s acceptance of our Drug Master File for interleukin-2 by the FDA, it is appropriate to highlight what such an acceptance means and why one should be concerned with the quality of any interleukin-2 used in their immunotherapy projects.
As the first immunotherapy approved by the FDA for treatment of metastatic melanoma, interleukin-2 (IL-2) has come a long way from where it was two decades ago: the subjects of extensive research, it remains one of the most important cytokines used in the development of cancer-targeting immunotherapies. There is compelling data of immune activation leading to cancer regression after treatment with IL-2 activated T-cells, and such research continues.
But not all interleukin-2s are the same: the path to the clinic – and eventually, regulatory approval and commercialization – is paved with a number of checkpoints that are often overlooked.
Oftentimes, when it comes to sourcing raw materials – including interleukin-2 – one of the most important factors taken into consideration is cost. This is a reasonable selection criterion, but one that fails to address the complexity and severity of proper selection of IL-2.
No consideration of cost should come at the expense of quality – but what does quality mean, exactly?
Across the industry, there is widespread confusion about terms such as “GMP,” “research grade,” “injectable grade,” “clinical grade,” as well as the importance and use of batch records, drug master files, SOPs and quality documentation. Common questions one should be expected to know the answers to are: when are these documents needed? Who is responsible for writing them? What kind of data and information is needed for each of them?
If you were asked which of the above are required for pre-clinical development of an IL-2-based immunotherapy, would you know? What about clinical trials?
Moreover, if you are currently a user of interleukin-2 either as a raw material in a current immunotherapy development process or as a reseller to end users , are you aware of the type of documentation available for the IL-2 and how the needs for this documentation change as the development pipeline progresses? What is needed at the research and development phase is very different to what one needs when submitting documents to the FDA. Not being adequately prepared often causes scrambles down the road and, more worringly, regulatory denials.
This happens often and has caused regulatory issues that have costed companies significantly more than it would have cost them had they sourced their raw materials correctly.
It is very common to underestimate the need for such documentation as well as background data supporting these products, but most of all, misunderstand the need for continued support and updates to such documentation.
Unfortunately, many IL-2 suppliers also do not have a full understanding of the clinical development process and as such, do not translate this information adequately to customers thereby further promoting miseducation about this.
Just like not all immunotherapies are the same, not all IL-2s are the same either: ask yourself, what kind of IL-2 is your supplier providing? What kind of data – stability, functionality, pre-clinical and clinical – are they able to provide you?
Do not be surprised if most of this information is not available, or if you are not able to obtain answers to such questions.
Make sure that your supplier is able to provide a full portfolio of information, data, but most importantly, support to help guide the development process.
While this post should not come across as a direct promotion of Akron Biotech’s interleukin portfolio, we want to highlight the unique prospect of working with us on your immunotherapy products: not only is our interleukin-2 (and many other growth factors) manufactured as pharmaceutical grade, the product is supported by an extensive dossier of data – from stability, to functionality, all based on international standards – that allows us to provide the right product for the right stage of development.
More importantly, the flexibility of adjusting documentation as your process changes is possible and done easily and quickly.
Ask yourself: is your current interleukin-2 right for you?