By Christa Myers, Associate / Lead Process Engineer – CRB
and Kevin Debbs, Process Specialist, CPIP – CRB
The age-old debate for mature, emerging and virtual biopharmaceutical companies remains whether to outsource production to a contract manufacturing organization (CMO) or not.
At the core of the issue is brand protection. While outsourcing can minimize capital and labor costs, the challenge lies in the process of evaluating and selecting the right CMO as your manufacturing partner. How can you minimize potential consequences, including damage to your brand and loss of market share and revenue? How can you minimize the risks to product quality, while ensuring that equipment, processes and procedures used in manufacturing will maintain the intended strength, integrity, safety, purity and quality of the drug or product? And how can you do it all within budget?
While the answers to these questions will be specific to each company and its products and processes, there are some key drivers to help you make the right decision if you do turn to a CMO. Keep in mind, these drivers need to be in line with your business goals and ultimately get your product to market in a safe, compliant and cost effective manner.
To learn more about these key drivers, visit the CRBlog at http://www.crbusa.com/blog/537-to-outsource-or-not-that-is-the-question
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