Perspectives

Biologic Products DNA to IND Timeline in 9 Months – Yes it can be done!

Apr. 11, 2019

Biologic Products DNA to IND Timeline in 9 Months – Yes it can be done!

The ability to rapidly develop biologic products from conception to human clinical trials is an increasingly important aspect of controlling drug development costs and in expediting the drug’s pathway to one day provide critical treatments. Hence, there has been an increased focus on ways to shorten the timeline through product development. These expedited timelines are especially important when dealing with infectious disease control.

At the recent CBI Speed to IND for Biologics Conference in San Francisco, there were many interesting talks on strategies for reducing time to IND. One of the talks was a perfect fit as it discussed a process that brought a product from DNA to IND in a record 9-month timeline for for biologics drug development (in this case, recombinant protein therapeutics produced from mammalian cell culture). It also highlighted the kind of collaboration that was necessary to achieve such timeline. The talk, “From DNA to IND in 9 Months – How organizations worked together to meet a national healthcare initiative,” was presented by Jie Chen, Vice President of CMC Management at WuXi Biologics.

To read the full article, please visit: https://cellculturedish.com/biologic-products-dna-to-ind-timeline-in-9-months-yes-it-can-be-done/.

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