©2009 American Type Culture Collection (ATCC). ATCC: A Model for Biological Materials Resource Management Frank Simione October 8, 2009

2 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL ATCC Overview Global non-government BRC Non-profit BRC [501(c)3] More than 95 years of experience and expertise Diverse collections in life sciences International Depository Authority (IDA) Global Distribution ISO 9001, 34 and ANSI Accredited SDO No government subsidy for collections

3 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL ATCC History 1964 – Owned facilities/Government Assistance 1973 – Financial Difficulty/Government Assistance 1975 – Seed stock system for QC/Government Assistance 1976 – Facilities needs/Government Assistance 1980 – IDA, IP protection & tech transfers/Government legislation 1982 – Scientific needs/Government Assistance

4 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL ATCC History 1985 – Data authentication & integrity/ Government assistance 1993 – Contemporary facility needs/Not capitalized 1998 – New Facilities/Capitalized 2009 – Financially Strong – revenue from: (1) Products and services (2) Government and commercial contracts

5 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL ATCC Operational Focus  Protection of biological assets for the advancement of life sciences  Uncompromising commitment to users in quality, standards, biosafety, biosecurity & regulatory compliance  Ensure standardization for global research activities

6 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL Biological Assets Protection  Microbial strains since 1925 including prior Winslow collection materials (1911)  Ensure biological resources meet changing scientific needs  Expansion of unique position as a knowledge and tech transfer broker between research & commercial entities  Manage business to ensure continuity and no loss of biological resources

7 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL Quality of Biological Materials  Strains are maintained as close as possible to original materials as received at ATCC  ATCC brand ensures high-quality standards with low passage numbers  New technologies are applied to AAPPDD activities  Continuous facility planning and standard operating procedures updates

8 ©2009 American Type Culture Collection (ATCC). CONFIDENTIAL Standardization  Authenticated and quality assured standard reference strains helping to ensure viability, reliability, reproducibility and validity  Proficiency Testing Standards Program  Quality control standard reference strains  Development of written consensus standards