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DNA to IND – 12 month antibody therapeutic development timeline

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.

 

WuXI Biologics 12 month DNA to IND Timeline

 

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.

  • A diligent, intensive and dedicated project management team

    Critical to achieving these expedited timelines is the employment of a highly-trained and dedicated project management team. The project managers (PMs) plan and work closely with all functional and technical teams from both the client and our organization to move the program efficiently between the various project phases. Our PM teams utilize widely-recognized industry project management tools and secure information sharing platforms to make communications efficient and timely.  

  • Over 400 industry veterans with 10-30 years's experience

    Every project has some type of technical hurdle or operational challenge and having extensive expertise and experience to manage those scientific and operational obstacles and finding solutions to ensure project timelines stay on track and maintain product quality is paramount. WuXi Biologics has over 400 industry veterans with 10-30 years’ experience, across all functional areas, including bioassay and formulation development and viral clearance validation study design and execution to enable right-first-time execution.