What Makes a Successful Due Diligence When In-Licensing a Pharmaceutical Product?

Posted by Wellspring Pharma Services

stockvault-paperclips104659When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed.  Navigating through all of the technical documents can be very time consuming and confusing.  The technical parameters that a company needs evaluate can be complex.  You need to glean as much technical information as possible on the manufacturing and packaging process itself as well as from Quality Control, Quality Assurance, Regulatory, and Logistics of a pharmaceutical product.  

You should go into the product due diligence with a detailed checklist to ensure you leave no stone unturned.  The goal, of course, is that you come out of the due diligence process fully aware of all the issues and potential issues of acquiring a pharmaceutical product – new or existing.  We've seen some clients acquire new products thinking everything was great, only to find out, for instance, that their methods were not USP standard methodologies, even though their plan was to market the product as USP standard.

What are the elements in a technical package that a pharmaceutical company might look at when trying to in-license a product?

Analytical methods are one of the critical factors to review right off that bat.  Analytical methods have to be current to today’s regulatory standards, but it even goes back further than that, based on the product’s formulation composition.  Is there supply of API? Is it reliable? Have you talked to the API suppliers? Maybe the company has some API in house but their supplier is dropping out.  How do you check that out? You need to call the suppliers of all the ingredients – API and key functional excipients.  It’s possible that they are no longer being made by these suppliers.  If that is the case, this could delay the launch of your product and cost your company hundreds of thousands of dollars in lost revenue.  The availability of a $10/kg material could cost you months of lost market sales.

We've had a couple of clients where they've acquired or in-licensed a product and wanting to start the transfer work only to realize that in one case the API supplier discontinued manufacturing that API so it was no longer available.  In another case, the lead time was close to eight months in getting an API sourced. It could be a couple of years by the time you find and qualify that new API supply, get it into your process, qualify the process and get the qualification lots placed on stability.  In extreme cases, you may not be able to launch the product at all.

Experienced Technical Help Can Help You Avoid Potential Pitfalls

Determining-Best-Manufacturing-Processes-Guide-For-Pharmaceutical-Products If you're a virtual company, you may not have the technical expertise to really sit down and understand what the manufacturing and packaging processes are or what the product nuances are.  How well were they documented in development reports? If there's even a development report because a lot of older products, they don't have that documentation.  Is there alcohol in the product?  Many manufacturers do not handle alcohol or other solvents in their facility and/or equipment due to safety or environmental issues – can yours?  Due diligence of all of these factors needs a really critical, experienced eye looking at and understanding just exactly what it is you might be buying.

If there's specific equipment that's required and you need to outsource the manufacturing of that product, how easily is that equipment available at your potential contract manufacturing partner sites?  Are some of the excipients even available, like we mentioned before?  How well were the process parameters developed?  Does the product require a lot more development work in order to get it to the point where it's approvable by a regulatory authority or is it an easy transfer?  What you may think is an easy transfer can turn into a long and very costly exercise in order to have the product in a position where you can market it.

If your company is considering buying a pharmaceutical product, you should really consider engaging the help of your existing manufacturing partner in the process right up front.  The sooner they're involved, and if that's the site where the product will be transferred to, the fewer unexpected challenges you will face down the road.  Hopefully, those issues can be identified with enough time so that solutions can be developed that will not delay your market introduction.

The technical people at your contract manufacturing site would probably have enough expertise to be able to look at a file objectively and find potential pitfalls within that product.  For example, if an analytical method is not specific enough or precise enough they may be able to identify that or uncover that for you in advance.  If there's a certain processing parameter that hasn't been well qualified or well documented they'll be able to tell you that also. They'll be able to help you avoid potential problems down the road.

Look at the Product’s Complaint History to Identify Quality Concerns

stockvault-pills-125957Lastly, when considering product quality, make sure you look into the complaint history for the product – it could give valuable insight into potential manufacturing issues and whether they have been adequately addressed.  Were there any FDA 483’s issued related to the manufacturing or testing of the product and were those satisfactorily addressed?  Were these issues adequately documented and reported to the regulatory agency?  Are there any documented commitments that the regulatory agency, like FDA is expecting to be completed that your company may have to assume once you acquire the product?  Again, these issues could delay the product getting to market and may be very costly to complete.

Time to complete a due diligence is usually very tight. You would be well served by developing a thorough check list that spans manufacturing, quality, regulatory and logistics. And, by doing that upfront, it makes the transfer so much easier. Fewer surprises along the way means a smoother tech transfer - where ultimately, you get to the market just that much quicker.

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Topics: Manufacturing Scale-Up

WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.

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