When you think of drug development and commercialization, you may not think at first 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 file a substance for commercialization with the FDA, a manufacturer must include a full description of the manufacturing process including the analytical procedures that prove the manufactured product meets prescribed standards.
Yet the FDA continues to raise the bar when it comes to regulatory requirements. Smart companies understand that strong and thorough analytical development is necessary, and it is not the time to cut costs or procrastinate.
Likewise, smart CMOs understand that strong analytical capabilities are what will differentiate them 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 equipment and technology in the world can’t compare to the talented scientists who operate them. CMOs that invest the most in qualified, 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 capabilities.
Below are questions every sponsoring company should ask of a potential CMO partner when it comes to analytical capabilities:
While it’s important that the CMO has the most current equipment and technology, what is more important is the experience of the staff. Anyone can throw money at equipment and other tools, but the people and skills are what distinguish the great CMOs from the mediocre to bad ones. Meet the analytical team and talk to the actual analysts and explore their approach, how they solve problems and see things.
It’s not only credentials or academic degrees that you should inquire about – it’s really all about the experience. Ask about the number and types of projects they have worked on, and how long they have been with the CMO. This type of information is what is really key. Sometimes their experience working at a smaller CMO gives them more responsibility, than being one of many scientists at a huge firm. And beware of a team that has a lot of new people because that can reflect a lot of turnover, which usually is not good for sponsors.
Always ask for referrals and drill down to see if the sponsor felt that the CMO was able to develop methods and resolve impurities in a systematic way. Find out whether they get a sense that the analytics they got were strong.
Not all CMOs have analytical capabilities in-house, and many outsource to contract laboratories that focus solely on analytics. Many CMOs at one point or another have to outsource some of their programs when demand for analytics is extremely high and they need to focus on manufacturing. Yet there are clear advantages to performing analytics in-house where information can be shared more readily with R&D and where there is greater collaboration and process flow.
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 defined, many companies wisely choose to invest early in their programs. Spending extra money early helps to avoid problems down the road, when the ramifications 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.