IS THE CDMO CREATIVE AND FLEXIBLE?
New drug compounds often need to be adjusted depending on early clinical testing. A sponsor company should be certain that
its CDMO has the necessary flexibility to address the changing needs of the compound and the market, such as new regulatory
demands, upcoming competitive products, and changing healthcare systems. Determine whether the CDMO team is nimble and able
to act quickly to update project specifications under tight timeframes. Be certain it has the expertise and dedicated staff
to offer proactive approaches to challenges that may occur at each stage of drug development.
ARE INTERNATIONAL QUALITY STANDARDS BEING MET CONSISTENTLY?
Today, aseptic manufacturing is becoming more rigorous and demanding. Regulatory bodies demand that CDMOs keep current with
new and emerging regulations and are enforcing more regularly quality standards around the globe. These rigorous standards
also mean that a partner's facility must remain cutting-edge, from the way it is built to the technology it uses. Providing
high quality yield of valuable product is a must.
IS THE CDMO'S FINANCIAL PICTURE CLEAR AND STABLE?
Because drugs take an extended period of time to develop, the relationship a sponsor company develops with a CDMO will often
be a long-term one. Thus, be certain that the contract organization is able to demonstrate independent financial standing.
A CDMO with a consistent history of organic growth is likely to be a strong partner, and also a strong ally.
DO YOU SHARE A COMMON VISION?
Good communication among team members, particularly in the beginning of a relationship, is not always easy to achieve. Differences
in corporate cultures and business models and varying levels of knowledge and experience are just a few of the issues that
can make communication among parties more difficult. Developing the right relationship and vision from the start will help
ensure that the sponsor company's plan for the future is equally shared by the CDMO.
Having choices is a good thing. However, it is important to understand your company's needs and goals when making a choice.
The recommendations offered in this article should help a sponsor company select the right CDMO for its organization. Any
partner will strongly influence a company's future, so choose wisely.
Peter Soelkner, managing director, Vetter, + 49 751 3700-0, info@vetter-pharma.com
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