Community Publications

The following publications from across industry, government, and academia address current challenges, opportunities, and plans for action in the regenerative medicine field. These collected publications provide a broad overview of current thinking in the community to help align efforts around common priorities. Please contact SCB if you know of a publication that should be featured on this list.

2021

The Importance of Feasibility Assessments in the Standards Development Process

  • Cell & Gene, July 2021

  • Author: Catherine Zander, Ph.D., Standards Coordinating Body

2020

Innovation in the Time of COVID-19: ARM Global Regenerative & Advanced Therapy Medicine Sector Report (H1 2020)

  • August 2020

  • Author: Alliance for Regenerative Medicine

ARM Annual Report & Sector Year in Review: 2019

  • March 2020

  • Author: Alliance for Regenerative Medicine

Risk Assessment Approach to Microbiological Controls of Cellular Therapies

  • PDA Journal of Pharmaceutical Science and Technology, January 2020

  • Authors: Anthony M. Cundell, Don Singer, Irving Ford, Scott Drummond, and Dona Reber

2019

TOWARDS A COMMON FRAMEWORK FOR DEFINING ANCILLARY MATERIAL QUALITY ACROSS THE DEVELOPMENT SPECTRUM

  • Cytotherapy, December 2019

  • Authors: Oliver Ball, Claudia Zylberberg

  • See also: SCB-coordinated project on ancillary materials used in cellular therapy production

WORKSHOP ON THE CHARACTERIZATION OF FIBER‐BASED SCAFFOLDS: CHALLENGES, PROGRESS, AND FUTURE DIRECTIONS

  • Journal of Biomedical Materials Research, December 2019

  • Authors: Lexi Garcia, Sherif Soliman, Michael P. Francis, Michael J. Yaszemski, Jayesh Doshi, Carl G. Simon Jr., Rebecca Robinson‐Zeigler

  • See also: SCB-coordinated project on fiber-based scaffolds

CELL MANUFACTURING ROADMAP TO 2030

  • November 2019

  • Authors: National Cell Manufacturing Consortium; National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT); Georgia Tech, Marcus Center for Therapeutic Cell Characterization and Manufacturing; Prepared by Nexight Group

CELL AND GENE THERAPY GMP MANUFACTURING IN THE UK: CAPABILITY AND CAPACITY ANALYSIS

  • November 2019

  • Author: Cell and Gene Therapy Catapult

CLINICAL TRIALS IN EUROPE: RECENT TRENDS IN ATMP DEVELOPMENT

  • October 2019

  • Author: The Alliance for Regenerative Medicine

CELL AND GENE THERAPY CATAPULT ANNUAL REVIEW 2019

  • July 2019

  • Author: Cell and Gene Therapy Catapult

GETTING READY: RECOMMENDATIONS FOR TIMELY ACCESS TO ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) IN EUROPE

  • July 2019

  • Author: The Alliance for Regenerative Medicine

LEADING INNOVATION: THE UK’S ATMP LANDSCAPE

  • July 2019

  • Authors: The Alliance for Regenerative Medicine, UK Bioindustry Association

REGENERATIVE MEDICINE & ONCOLOGY REPORT

  • June 2019

  • Author: The Alliance for Regenerative Medicine

REGENERATIVE MEDICINE & INHERITED BLOOD DISORDERS REPORT

  • April 2019

  • Author: The Alliance for Regenerative Medicine

REGENERATIVE MEDICINE & RARE DISEASES REPORT

  • February 2019

  • Author: The Alliance for Regenerative Medicine

2018

CIRCULAR OF INFORMATION FOR THE USE OF CELLULAR THERAPY PRODUCTS

  • October 2018

  • Authors: AABB, America’s Blood Centers (ABC), American Red Cross (ARC), American Society for Apheresis (ASFA), American Society for Blood and Marrow Transplantation (ASBMT), College of American Pathologists (CAP), Cord Blood Association (CBA), Foundation for the Accreditation of Cellular Therapy (FACT), ICCBBA, International Society for Cellular Therapy (ISCT), Joint Accreditation Committee of ISCT and EMBT (JACIE) Accreditation Office, National Marrow Donor Program (NMDP), World Marrow Donor Association

FDA AND NIST COLLABORATION ON STANDARDS DEVELOPMENT ACTIVITIES SUPPORTING INNOVATION AND TRANSLATION OF REGENERATIVE MEDICINE PRODUCTS

  • Cytotherapy, June 2018

  • Authors: Judith A. Arcidiacono, Steven R. Bauer, David S. Kaplan, Claire M. Allocca, Sumona Sarkar, Sheng Lin-Gibson

SUMMARY OF THE NIST AND U.S. FDA CELL COUNTING WORKSHOP: SHARING PRACTICES IN CELL COUNTING MEASUREMENTS

  • Cytotherapy, June 2018

  • Authors: Sheng Lin-Gibson, Sumona Sarkar, John Elliot

ALLIANCE FOR REGENERATIVE MEDICINE 2018 ANNUAL DATA REPORT

  • February 2018

  • Author: Alliance for Regenerative Medicine

2017

POINTS TO CONSIDER FOR CELL MANUFACTURING EQUIPMENT AND COMPONENTS

  • Cell & Gene Therapy Insights, December 2017

  • Authors: Sheng Lin-Gibson, Brian Hanrahan, Sandro Matosevic, Aletta Schnitzler, Jiwen Zhang, & Claudia Zylberberg

COMMENTARY: NEW BODY FOR REGENERATIVE MEDICINE LAUNCHED

  • MedNous, a publication of Evernow Publishing Ltd., May 2017

  • Alexa Machikas and Elena Kfoury

2016

GUIDELINES FOR STEM CELL RESEARCH AND CLINICAL TRANSLATION

  • May 2016

  • Author: International Society for Stem Cell Research (ISSCR)