Twelve months, from initiation of gene synthesis to start cell line development activities, to release of drug product, including one month of stability data, is a remarkable undertaking for antibody therapeutics. It can be accomplished by using a single-source provider that has a well-established, high-quality, flexible and robust drug development platform across all IND-enabling project phases and CMC activities. WuXi Biologics has spent the past 5 years fine-tuning its one-stop service offering to provide our clients a routine 12-month DNA to IND program for multiple biologic product types.
Advantages of an expedited 12-month DNA to IND Timeline with WuXi Biologics:
- Expedite critical medicines into the clinic
- Reduce development costs and internal burn rate compared to traditional timelines
- Simplify project execution by using a single-source versus multi-vendor model
- Achieve competitive advantage by entering clinical trials earlier than competing products
We have a proven track record of expediting global IND filings in 12 months or less.. Additionally, in early 2020, more than 240 scientists at WuXi Biologics were mobilized and worked with multiple clients across the globe to utilize our one-stop technology platforms to accelerate the development of potential antibody-based COVID-19 treatments in only 4 to 6 months (see stories below on 6, 7 and 9 month DNA to IND timelines).
WuXi Biologics’ single-source technology platform, that includes our high performing WuXiaTM cell line development system and our U.S. FDA and EMA-approved quality systems and facilities, is one of the key drivers that enables these accelerated project timelines.