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API Regulatory Challenges: 5 Things You Need to Avoid

At the heart of every drug lies one or more active pharmaceutical ingredients (APIs). While the phrase “regulatory affairs” typically conjures thoughts of FDA approvals of finished-dose drugs, regulatory matters affect the entire production chain – and especially APIs.  In fact – as the core of any drug – their regulatory progress (and success) is mission-critical for drug-makers.

Believe it or not, treating APIs as “just another supply chain issue” is a common trap for some pharma firms. And while APIs aren’t quite the same as ordering copy paper or coffee filters, life science firms can jeopardize the success of their products by minimizing the importance of the regulatory aspects of their product’s key ingredients.

API development and commercialization poses a number of unique regulatory challenges for today’s pharma companies. Here are five common API regulatory mistakes to avoid:

  • Choosing the Wrong API Vendor
    Selecting a vendor for your API will depend on a number of factors, including their familiarity with your molecule or class of molecule, the strength of their Chemistry, Manufacturing and Controls (CMC) program (or the availability of CMC information for existing APIs), their ability to secure DMFs, pass regulatory inspections and function successfully with your target market’s regulatory agencies.Remember: regulatory education matters – especially if you’ll be participating in supplier evaluation. Outsourcing your API is fine, but it’s important for you to understand your API’s regulatory path and what your potential supplier-partner will need to do (and whether they have the capability to do it).
  • Incomplete Stability Data
    New APIs mean a lack of stability data, and that doesn’t bode well for regulatory success…or established expiration dates. Make sure you’ve considered this, and your supplier/partner can handle any studies that need to occur. If outsourcing stability testing to a third party, it’s important to ensure the smooth transfer of data and knowledge from your supplier to the testing provider. Make sure stability studies are performed in accordance with ICH guidelines and other protocols.
  • Weak Impurity Characterization
    Analytical and other testing methods must be developed and validated. Remember: identifying, characterizing and synthesizing your API is crucial…but so is identifying, characterizing and synthesizing the impurities that typically surround it. Bottom line: the impurity profile matters to your API’s regulatory success.
  • Problems With Genotoxic Impurities
    In our experience, Genotoxic Impurities can be a major source of regulatory headaches. Analytical methods need to be highly-sensitive to best detect them. And while many genotoxic impurities can be avoided (such as with Route changes, discussed below), often times your manufacturing partner will need to focus on controlling them – whether by adjusting environmental controls, altering purge strategies, using preservatives or another means.
  • Wrong Purification Route Selection
    Having a strong understanding of regulatory matters can affect how processes are developed. In some cases, altering the synthetic route or changing a purification route can minimize the formation of impurities – and ease your product’s regulatory path forward.

API vendor selection, stability studies, impurity characterization, genotoxic impurities, purification route selection – these are just a few of the Active Pharmaceutical Ingredient (API) trouble-spots and regulatory challenges facing the pharma & biopharma industries today.

What API regulatory challenges do you consider important?


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