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When you think of drug development and commercialization, you may not think at rst that the
analytical stage is very exciting, but what happens during analytical development may be one of the
most critical elements, with the ability to make or break your drug’s successful commercialization.
As mentioned in the previous post, analytical procedures are necessary to ensure the identity,
strength, quality, purity, and potency of a drug substance and drug products. In order to le a
substance for commercialization with the FDA, a manufacturer must include a full description of the Accelerate your API
manufacturing process including the analytical procedures that prove the manufactured product manufacturing
meets prescribed standards.
project, please
Yet the FDA continues to raise the bar when it comes to regulatory requirements. Smart companies contact us
understand that strong and thorough analytical development is necessary, and it is not the time to First Name*
cut costs or procrastinate.
Likewise, smart CMOs understand that strong analytical capabilities are what will differentiate them Email*
in an increasingly competitive marketplace. Here at PCI, we have invested millions of dollars in our
analytical staff, as well as in state-of-the-art equipment, but what we have learned is that all the
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equipment and technology in the world can’t compare to the talented scientists who operate them.
CMOs that invest the most in quali ed, expert scientists who can develop robust analytical methods,
most often prove to be the most successful. One of the biggest complaints we have heard from
prospective clients is that their previous CMO had poorly developed and executed analytical
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capabilities.
Below are questions every sponsoring company should ask of a potential CMO partner when it comes
to analytical capabilities:
Regardless of where it is conducted, analytical method development is a continuous and interconnected activity conducted throughout
the drug development process. While validated methods often produce results within known uncertainties, the results are crucial to
continuing drug development.
For most projects, sponsoring companies should plan on spending 25 to 35 percent of the total program cost on analytics over a six-to-
eight-month period (or $200,000 to $300,000 for a $1-million project), and any less should be carefully reconsidered.
While the amount of analytical development work conducted in the early stages of drug development is fairly discretionary until the
process is fully de ned, many companies wisely choose to invest early in their programs. Spending extra money early helps to avoid
problems down the road, when the rami cations are not only more costly, but also can result in failed programs.
Picking a CMO partner that understands the critical role of analytics is one of the most important tasks of any company hoping to bring its
substance to successful commercialization.
Our blog is designed to provide objective, actionable information. If this was helpful, consider our articles on Process Research Best
Practices: 8 Ways to Lower Drug Development Costs and Keep Projects on Track or Four Ways the Kilo Lab Development Phase of Drug
Manufacturing Can Save Time and Money.
Related posts:
Managing Risk in API R&D How to Select a CMO: Part From Molecule Discovery to Process Research Best Are CDMO’s Reducing
Requires Strategic 2 Commercialization: Why it’s Practices Drug Development Costs?
Planning, Collaboration and Good to Have One CDMO
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