Part 6 — In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 6 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

When you are looking at acquiring or in-licensing a pharmaceutical product, there are numerous technical factors that you should carefully consider, including the manufacturing and packaging process itself as well as quality control, quality assurance, regulatory affairs and logistics. Approach a new product with due diligence and a detailed checklist to ensure you leave no stone unturned.

Your goal, of course, is to come out of the due diligence process fully aware of all the issues or potential issues surrounding the acquisition of a pharmaceutical product — new or existing. We’ve seen some clients acquire new products thinking everything was great, only to find out that their methods were not up to U.S. Pharmacopeial Convention (USP) reference standards, even though their plan was to market the product as USP standard.

When in-licensing a product, analytical methods are one of the critical factors you need to review first. Analytical methods have to be current to today’s regulatory standards and based on the product’s formulation composition. Another critical factor is API. Due diligence requires that you call the suppliers of all the ingredients — API and key functional excipients — because if those ingredients are no longer available from existing suppliers for any reason, your product launch could be delayed and you could lose substantial revenue. We’ve seen cases where a client in-licensed a product only to realize the supplier discontinued the API and that the lead time to source a replacement was months away.

Experience Can Help Avoid Pitfalls

Small and virtual companies may not have the technical expertise to understand the nuances of the manufacturing and packaging processes, and that information may not be documented in development reports, assuming they exist. Another pitfall may occur if the product process requires special handling capabilities — for example, if the product contains alcohol. Many manufacturers do not handle alcohol or other solvents in their facility and/or equipment due to safety or environmental issues. Can your manufacturing site?

Due diligence requires you have a critical, experienced eye looking at and understanding exactly what it is you may be buying and how it will fit into your operation. If you don’t have experienced in-house resources to perform a due diligence audit, seek out experienced consultants or your preferred, experienced CMO who knows what to look for — they should have experience with a multitude of technical transfer projects and dosage forms.

Does the product require a lot more development work for it to be approved by a regulatory authority or is it an easy transfer? It pays to be sure, because what you may think may be an easy transfer can turn into a long and very costly exercise to actually bring it to market.

Lastly, when assessing 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. For example, you should consider:

  • Were there any FDA 483s 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 is expecting to be completed that your company may have to assume?

Again, these issues could delay your ability to get the product to market and may be very costly to complete.

Involve Your CMO Early in the Process

Assessment Qualification with a CMO PartnerIf your company is considering buying a pharmaceutical product, engage the help of your existing manufacturing partner in the process from the beginning. The sooner they’re involved, the fewer unexpected challenges you will face down the road.

The technical staff at your CMO should be able to find potential pitfalls. For example, if an analytical method is not specific or precise enough, or if there’s a certain processing parameter that hasn’t been well qualified or well documented, your CMO will be able to tell you. This can help you avoid potential problems down the road.

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. By doing this upfront, it makes the tech transfer much easier, with fewer surprises along the way.

Dig deeper. Request our eBook, “Technology Transfer Success with a CMO Partner: Ensuring On-Time Product Launches, Quality Products and Well-Managed Programs.”

Next Time: Part 7 — How Does the FDA's Process Validation Guidance Simplify a Technology Transfer? 

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Topics: due diligence, excipients, development reports, in-licensing, API, complaint history, USP standard

Norm is the technical transfer manager, business development, for WellSpring. He has over 21 years in the pharmaceutical manufacturing industry and has held development, transfer and commercial manufacturing positions over the course of his career with Patheon, Global Pharm (formally Pharmacia Upjohn) and Genpharm (owned by Merck). Norm is responsible for overseeing technology transfer and all validation activities in the organization.

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