(0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Sep 24, 2013 8:30 AM - Sep 24, 2013 5:00 PM

1750 Rockville Pike, , Rockville, MD 20852 , USA

The Development of Live Biotherapeutics

Back to Agenda

Product Definition and Characterization

Session Chair(s)

Ann Sutton, MPH

Ann Sutton, MPH

Senior Consultant

The Biologics Consulting Group Inc., United States

Selection of strains to be included in an LBT should consider source histories to support safety assessment. Establishing methods for strain-specific identity testing will support product control and clinical development. Final identity and potency testing as viable count for products that consist of 2 or more strains may pose challenges. Assurance of purity requires sensitive in-process control and release testing for detection of extraneous contaminants.

Speaker(s)

Trevor Lawley, PHD

Rational Selection of Candidate Bacteria for Bacteriotherapy Development

Trevor Lawley, PHD

Wellcome Trust Sanger Institute, United Kingdom

Faculty

John Aunins

Manufacturing Issues in Working with Live Products

John Aunins

Ventures/Seres Health, United States

Executive Vice President, CMC

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.