Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB)

At a Glance
  • Status: Active Consortium
  • Year Launched: 2011
  • Initiating Organization: Massachusetts Institute of Technology
  • Initiator Type: Academia
  • No disease focus
  • Location: North America

Abstract

The Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) aims to advance the safe and reliable production of biopharmaceuticals by mitigating the risk of cell culture contamination through agents such as viruses or mycoplasma, by creating a central database of accumulated industry knowledge. Currently, industry knowledge about contaminating adventitious agents and successful approaches to combat them is largely limited to each company’s individual experience. The collection, analysis, and dissemination of the full body of industry experience would enhance the reliable manufacture and supply of such safe and effective medications. This consortium operates under the umbrella of Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation (CBI).

Mission

Currently, data and expertise from the pharmaceutical industry for combating the contamination of cell-based therapeutics is largely limited to each company’s individual experience. CAACB aims to centralize the collection, analysis, and dissemination of the full body of industry experience to enhance the reliable manufacture and supply of such safe and effective medications. CBI coordinates the consortium.

CAACB’s specific goals are (a) confidential collection and analysis of industry adventitious agent contamination data and (b) dissemination of the most effective industry practices used to combat contaminations during the reliable manufacture of lifesaving biotherapeutic medications.

Consortium History

2014: CAACB hosted a workshop on “The Role of Testing in Control of Viral Contamination in Biopharmaceutical Manufacturing” at the MIT Media Lab.

2014: Michael Wiebe, CAACB lead investigator, and Paul Barone, CAACB associate director, co-presented “An Update on the Activities of the Consortium on Adventitious Agent Contamination in Biomanufacturing” and “An Update on the CAACB Virus Contamination Project” at the PDA/FDA Virus and TSE Safety Conference in Bethesda, Maryland.

2013: CAACB hosted a workshop on “Adventitious Agent Control in Non-Sterile Cell Culture Operations” at the MIT Media Lab on December 9 and the Boston Marriott Cambridge on December 10.

2013: CAACB hosted a workshop on “Virus Risk Assessment Approaches” at the MIT Faculty Club on June 24 and the Boston Marriott Cambridge on June 25.

2013: Stacy L. Springs, executive director of CAACB and Biomanufacturing Research Program, presented “Leveraging Collaborative Innovation: The BioMAN Research Program and Consortium on Adventitious Agent Contamination in Biomanufacturing” at the Annual Bio-Manufacturing & Process Innovation Leaders Summit in Boston.

2013: Michael Wiebe, CAACB lead investigator, presented “The MIT/Industry Initiative on Preventing Adventitious Agent Contamination in Biomanufacturing” at the PDA European Virus & TSE Safety Forum in Berlin.

2013: James C. Leung, CAACB lead investigator, presented “An Academic and Industry Collaborative Initiative on Preventing Adventitious Agent Contaminations in Biomanufacturing” during CBI’s seminar series.

2013: James C. Leung, CAACB lead investigator, presented “An Academic and Industry Collaborative Initiative on Preventing Adventitious Agent Contaminations in Biomanufacturing” at the IS Biotech 3rd Annual Meeting in Rosslyn, Virginia.

2013: Michael Wiebe, CAACB lead investigator, presented “The MIT/Industry Initiative on Preventing Adventitious Agent Contamination in Biomanufacturing” during the Viral Safety for Biologics session at the IBC Biopharmaceutical Development and Production week in Huntington Beach, California.

2012: CAACB hosted a workshop on “Virus Contamination” at the MIT Faculty Club on December 13. The workshop consisted of open discussions focused on the viral contamination data collected from consortium members. The event brought together more than 40 people from 15 different companies and organizations.

2012: CAACB hosted a workshop on “Media Treatment in Biomanufacturing” at the MIT Faculty Club on June 21 and 22. The workshop consisted of 1.5 days of talks, open discussion, and networking focused on high temperature short time treatment of cell culture media to inactivate adventitious agents, as well as several alternative methods, such as ultraviolet-C treatment. The event brought together more than 50 people from 19 different companies and organizations.

2011: Houman Dehghani, of Amgen, presented on “Maximize the Knowledge of Past Virus Contamination Events to Benefit the Future—An MIT-led and Industry-Sponsored Project” about the CAACB initiative at the PDA Virus and TSE Safety Forum in Barcelona.

2010: Michael Wiebe presented “Industry Consortium on Adventitious Agent Contamination in Biomanufacturing” at the PDA/FDA workshop on Adventitious Viruses in Biologics: Detection and Mitigation Strategies.

2010: A CAACB representative presented at the 2010 BioMAN Summit Science to Manage Risk in Biomanufacturing.

2010: The CAACB kick-off meeting took place.

Structure & Governance

Consortium Organizers:
Paul Barone, Ph.D.
Associate Director, CAACB
Associate Director, BioMAN Program, MIT CBI
pbarone@mit.edu

James Leung, Ph.D.
Lead Investigator, CAACB
leungjc@mit.edu

Stacy Springs, Ph.D.
Executive Director, CAACB
Director, BioMAN Program, MIT CBI
ssprings@mit.edu

Michael E. Wiebe, Ph.D.
Lead Investigator, CAACB
President and Founder, Quantum Consulting
quantumco@comcast.net

Faculty Director:
Anthony Sinskey, Sc.D.
Faculty Director, MIT CBI
Professor of Biology and Health Sciences and Technology, MIT

Impact/Accomplishment

CAACB’s aim is to provide a standardized and comprehensive analysis of adventitious agent contamination data to inform the pharmaceutical industry on the best practices to mitigate the risks that lead to adventitious agent contamination. Specifically, CAACB seeks to develop a comprehensive understanding of the adventitious agents encountered, the source of such agents, and a risk-based analysis of the most effective barriers to contamination. The collection, analysis, and dissemination of this information should enhance the uninterrupted supply of vital, safe, and effective biotherapeutic medications.

Points of Contact

cbi@mit.edu
phone: 617-324-9640
fax: 617-253-0687

Sponsors & Partners

Amgen

Aquafine

AsahiKASEI Bioprocess

Baxter

Biogen Idec

BioMarin

Boehringer Ingelheim

Bristol-Myers Squibb

Genentech

Genzyme

Histogenics

MedImmune

Life Technologies

Lilly

EMD Millipore

Novartis

PALL

Pfizer

Sanofi

Sanofi Pasteur

Shire

SAFC


Last Updated: 04/14/2016

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