PACT continues to achieve its objectives in contributing to the advancements in the field of cellular therapy through information exchange and research.
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FDA Webinar Resources
- OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn)
FDA Guidances
Websites
- Information on Submitting an Investigational New Drug Application for a Biological Product
- CBER Guidance, Compliance and Regulatory Information (Biologics)
Gene Therapy Guidances
- Draft Guidance for Industry: Chemisty, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), July 2018
- Draft Guidance for Industry: Long Term Follow-up After Administration of Human Gene Therapy Products, July 2018
- Draft Guidance for Industry: Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacturing and Patient Follow-up, July 2018
- Draft Guidance for Industry: Human Gene Therapy for Hemophilia, July 2018
- Draft Guidance for Industry: Human Gene Therapy for Rare Diseases, July 2018
- Draft Guidance for Industry: Human Gene Therapy for Retinal Disorders, July 2018
Guidance Documents
- Draft Guidance for Industry: Rare Diseases: Common Issues in Drug Development, Jan 2019
- Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception, Nov 2017
- Guidance for Industry: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, Nov 2017
- Draft Guidance for Industry: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, Nov 2017
- Draft Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, Nov 2017
- Guidance for Industry: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, Nov 2017
- Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, Nov 2013
- Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products, June 2015
- Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, Jan 2011
- Guidance for Industry: Cellular Therapy for Cardiac Disease, Oct 2010
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), April 2008
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), April 2008
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Aug 2007
- HHS-FDA Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishment; Inspection and Enforcement; Final Rule, Nov 2004
- Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, Sept 2004
- HHS-FDA Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule, Feb 2004
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy, March 1998
FDA Presentations
US/International Organizations
- AABB on Cellular Therapies
- The American Association of Immunologists (AAI)
- American College of Cardiology (ACC)
- American Heart Association (AHA)
- Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA)
- American Society for Apheresis (ASFA)
- American Society for Blood & Marrow Transplantation (ASBMT)
- American Society of Gene & Cell Therapy (ASGCT)
- American Society of Hematology (ASH)
- American Thoracic Society (ATS)
- Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC)
- Biotechnology Industry Organization, Cell & Gene Therapy Committee (BIO)
- Center for International Blood and Marrow Transplant Research (CIBMTR)
- California Institute for Regenerative Medicine (CIRM)
- Cell Transplant and Regenerative Medicine Society (CTRMS)
- European Society for Blood and Marrow Transplantation (EBMT)
- FDA INTERACT Program
- Foundation for the Accreditation of Cellular Therapy (FACT)
- International Society for Cellular Therapy (ISCT)
- International Society for Stem Cell Research (ISSCR)
- The Joint Accreditation Committee EBMT-ISCT Europe (JACIE)
- National Marrow Donation Program (NMDP)
- Regulatory Affairs Professionals Society (RAPS)
- Tissue Engineering International & Regenerative Medicine Society (TERMIS)
Cell and Gene Therapy Programs
- NIH Regenerative Medicine Innovation Project (RMIP)
- NIH Regenerative Medicine Program - Stem Cell Lines
- National Gene Vector Biorepository (NGVB)
- Gene Therapy Resource Program (GTRP)
On-line Cell Therapy Resources
- Circular of Information for the Use of Cellular Therapy Products
- BioCoR
- Cell Therapy News
- National Institutes of Health Stem Cell Information
- Stem Cells Translational Medicine journal - Register for free online access.
AABB Transfusion and Cellular Therapies Suppliers Guide
AABB Transfusion and Cellular Therapies Supplier Guide is an online resource for the field of transfusion and cellular therapies providing a one-stop resource listing of only the products and services relevant to the field of transfusion and cellular therapies.
AABB Transfusion and Cellular Therapies Suppliers Guide
ISCT
The Cell Therapy Bioprocessing Tools and Reagents Database, developed by the ISCT Commercialization Committee, is a free, centralized and universal source for new and available products used in cell therapy processing, manufacturing and research. The database connects end users with other users and manufacturers.
Registration is required to access the database. Click on the image below to register with ISCT.
(You must have ISCT member status to view this site)
Cell Therapy Books
NHLBI PACT Supported:
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Cell Therapy: cGMP Facilities and Manufacturing Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. |
This volume contains a collection of chapters authored by individuals who are active in the field of cell therapy product manufacturing. The collection and editing of these chapters was supported in part by the National Institutes of Health (National Heart, Lung and Blood Institute) program Production Assistance for Cellular Therapies (PACT). (2009, 256 p. 62 illus., 11 in color., Hardcover) All book orders are to be processed through Springer Print and complete this form to order a copy via postal mail or fax. Mailing information is included in the form. |
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AABB Publications:
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Standards for Cellular Therapy Services, 7th edition The seventh edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.
(2015, AABB, softcover, 154 pages) |
(AABB, 2014, ISBN# 978-1-56395-913-4)
List Price: $200
AABB Member Price: $175
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Core Principles in Cellular Therapy, 3rd edition This handy text provides a focused look at hematopoietic and nonhematopoietic cellular therapy that will be useful to those working on the periphery as well as the mainstream of this exciting field. Written by experts, these chapters excerpted from the AABB Technical Manual, 18th edition, were also peer-reviewed by AABB cellular therapy committee and subsection members. Together, these chapters capture what is essential to know about cellular therapy and regenerative medicine—for example, new advances in induced pluripotent stem cells, mesenchymal stem cells, adipose-derived stem cells— as well as more established cellular therapy products. |
(AABB, 2014, ISBN# 978-1-56395-892-2) Product Code: 143030 |
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Cellular Therapy: Principles, Methods, and Regulations, 2nd edition This manual was designed as a compendium of state-of-the-art practices and methods for developing and producing cellular therapy products, and for development and operation of a cellular therapy facility, whether for research, translational or clinical. Applicable to academia, government and industry, it is also an essential reference for those in regulatory affairs and quality assurance as well as for laboratory technologists, managers, directors, physicians and scientists. Through descriptions of the rationale and methodology for a variety of cell processing and evaluation techniques, it will assist laboratory staff in developing procedures that comply with applicable regulations and standards. In addition to numerous examples and templates for laboratory document preparation, several methods are provided that include a general overview of the critical steps, materials and equipment used in each process. Each section has been compiled and edited by a team of experts in the field, with subchapters contributed by specialists in the specific subject matter. As regenerative medicine becomes more integrated into the field, considerations for regenerative therapies are also integrated within each section. |
(AABB, 2016, hard cover, 897 pages, ISBN# 978-1-56395-916-5) Product Code: 153420 |
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Hematopoietic Stem Cell Transplantation: A Handbook for Clinicians, 2nd edition This second edition of Hematopoietic Stem Cell Transplantation: A Handbook for Clinicians (HSCT) offers comprehensive and practical information for healthcare providers working in the HSCT field. It provides relevant information on all areas of HSCT, including indications for transplantation; donor and patient evaluation; conditioning regimens; collection, processing, and characterization of stem cell products; management of immunosuppressive therapy; evaluation and management of the most common complications during HSCT; supportive care management; common procedures; and aspects of follow-up care. The emphasis of the Handbook is placed on providing up-to-date information in a clinically meaningful way. This edition’s content has been reorganized to facilitate finding topics of interest more easily and the authors emphasized an educational bent in presenting their material. Each of the topics in the first edition has been revised to ensure the content is up to date. New chapters covering nonmalignant diseases, haploidentical transplants, photopheresis, financial considerations, and iron overload have been added. |
(AABB, 2015, ISBN#978-1-56395-876-2) Product Code: 143425
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Other Cell Therapy Publications of Interest
Circular of Information for Cellular Therapy Products September 2013
Immunology
Handbook of Human Immunology Second Edition By Maurice R. G. O'Gorman and Albert D. Donnenberg. 2008. CRC Press. Taylor and Francis Group (623 pages).
Cell Preservation
Advances in Biopreservation, ed. John G. Baust, CRC Press, Boca Raton, FL, USA, 2005.
This book covers a range of topics from preservation fundamentals to specific techniques. Systems studied include macromolecules, cells, and tissues (native and engineered). Life in the Frozen State, Ed. Fuller, B.J., Lane, N, Benson, E, CRC Press, London, 2004.
The preservation of cells, tissues, and gametes and supplemented by an extensive discussion of plant, bacteria, fungi preservation.
Clinical applications of Cryobiology, Ed. Fuller, B.J., Grout, B.W.W., CRC Press, Boca Raton, FL, USA, 1991.
NIH Regenerative Medicine Innovation Project (RMIP)
2020 RMIP Funding Opportunity Announcements
- Title: RMIP Investigator-Initiated Clinical Trials
- ID Number: RFA-HL-21-003
- Activity Code: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
- Earliest Submission Date: September 2, 2020
- Application Due Date: October 2, 2020
NHLBI Funding Opportunities
NINDS Funding Opportunities
- PAR-17-456 CREATE Bio Optimization Track for Biologics (U01)
- PAR-17-457 CREATE Bio Optimization Track for Biologics (SBIR-U44)
- PAR-18-542 CREATE Bio Development Track: Nonclinical and Early-Phase Clinical Development for Biologics (U01 Clinical Trial Optional)
- PAR-18-543 CREATE Bio Development Track: Nonclinical and Early-Phase Clinical Development for Biologics (U44 Clinical Trial Optional)