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Unlocking the Best Solution for API Sourcing

Janel Firestein was referenced in an article in PharmTech magazine, highlighting the best solution for API sourcing. An excerpt from the article can be found below.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

Global government regulatory agencies are paying increasing attention to the contract manufacturing space, with increased inspections particularly of overseas contract manufacturing/contract development and manufacturing organizations (CMOs/CDMOs) supplying the US market. At the same time, most pharmaceutical companies are focusing on supply chain diversity as a risk management/mitigation strategy. The increasing complexity of APIs and drug delivery technologies is also leading sponsor firms to seek service providers with demonstrated expertise in complex chemistry, high-potency API production, and small-volume manufacturing. Manufacturers of APIs are crucial links in the pharmaceutical industry supply chain. Selecting the right API supplier has become essential for the success of any new drug development or commercialization project.

An effective selection process
Before the selection of API suppliers begins, it is important to conduct an internal needs assessment in order to understand the expertise needed to support a company’s entire API portfolio, according to Janel Firestein, life-sciences lead at Clarkston Consulting.

In addition to having the right technical capabilities and resources to support production needs both today and in the future based on the pharma company’s organizational strategy, the right supplier will be able to demonstrate compliance, flexibility, and costs for any existing, established APIs it produces, as well as have a proven track record for hitting regulatory milestones successfully, according to Firestein. She adds that the ideal CMO/CDMO will also have the ability to partner in support of other portfolio and pipeline projects, have innovative technical capabilities in early-phase formulation development, and have developed a roadmap that shows commitment to keeping their facility compliant and efficient.

To view the full article continue through to PharmTech’s site: Unlocking the Best Solution for API Sourcing.

To schedule an appointment with Clarkston Consulting or to connect with Janel Firestein, please contact us.