Resource Center

PACT continues to achieve its objectives in contributing to the advancements in the field of cellular therapy through information exchange and research.

Contact Us if you would like to be added to our distribution list for PACT updates (e.g., Web Seminars, Newsletters)

 

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PACT Updates
Clinical Research Roadmap

Cellular Therapy: Clinical Research Roadmap

The NHLBI Production Assistance for Cellular Therapies (PACT) Program’s Cellular Therapy Clinical Research Roadmap was developed by PACT’s cell processing facilities (CPF). The roadmap was developed as a resource for researchers new to the field of cellular therapy. It is intended to provide a high-level overview that will assist researchers in the identification of the critical areas that need to be considered when developing a cellular therapy intended for evaluation in human clinical studies under an Investigational New Drug (IND) application.

Click here to view the roadmap.

Click on the blue boxes under each category below to view the critical areas.

SOP Request

PACT provides general facility SOPs upon request to assist you in developing your own cell processing facility SOPs. PLEASE NOTE that these SOPs are for INFORMATIONAL PURPOSES ONLY and therefore require validation by your own facility. Below in the table are the SOPs currently available. Once you have provided all required information, we will process your request as soon as possible. You should receive the SOPs you have requested in Adobe Acrobat format.  If the link above does not function properly with your email client, you may simply send us an email to the address below with the same information.

Click here to request one or more SOPs
*This will open an email window with an email request.

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Cleaning Procedures
  • Changeover Procedure between Cellular Therapy Products
  • Cleaning Procedures for the GMP Cell Processing Facility
  • Facility Cleaning
  • Facility Cleaning and Waste Disposal
Deviation Management
  • Deviation from Written Procedures
  • Deviation Management Program
  • Variance and Incident Reports
Environmental Monitoring
  • Decontamination of Material and Equipment
  • Environmental Monitoring (3 SOPs)
  • Gowning for Controlled Environment Areas
  • Technical Procedure Template
Personnel Training
  • Cell Therapy Training
  • Employee Training Program
  • Personnel Training
  • Retrospective Documentation of Training
Quality Assurance/Quality Control
  • Batch Record Review
  • Corrective and Preventative Action
  • Laboratory Out of Specification Investigation Procedure
  • Laboratory Patient Chart Review and Product Release Policy
  • Quality Assurance Review
Quality Management
  • Change Control Program
  • Document Change Control
  • Documentation System
  • GMP-GTP Manufacturing Facilities Quality Management Plan
  • Preclinical Study Progress Report
  • Product Quality Assurance Program and Release and Return of Clinical GMP/GTP Product
  • Product Receipt and Inspection
  • Quality Management Program
  • Quality Manual
  • Receipt and Inspection of Reagents, Media and Supplies
  • Receipt and Issue of Cellular Product for Pre-Clinical Studies
  • Request for Processing and Releasing of Product
  • Transport and Storage of Hematopoietic Progenitor Cell Products
  • Transportation of Cryopreserved Cells
  • Transportation of Cryopreserved Cellular Therapy Products
  • Transportation of Non-Cryopreserved Cellular Therapy Products
Standard Operating Procedures (SOP): Development & Management
  • Document Control and Generation and Management of Standard Operating Procedures
  • Standard Operating Policies, Processes and Procedures (SOPs)
  • Standard Operating Procedures
Validation Process
  • Equipment Installation and Qualification
  • Equipment Qualification
  • Material and Equipment Specifications
  • Ordering Materials
  • Process Validation
  • Supplier/Vender Qualification
  • Validation
  • Validation, Verification and Qualification Program
  • Vendor Qualification Process
Links to Other SOPs and Regulatory Documents

Association of Academic Biologics Manufacturers (AABM) is a cooperative network of non-profit academic based biologics manufacturers serving as a national resource to bring together clinical investigators with manufacturing capacity and expertise, develop and share facility operations expertise amongst members, provide quality, manufacturing and regulatory training opportunities, and hold annual meetings. AABM has assembled a library of SOPs that are available to registered members. The available SOPs cover such areas as facility operations, biological waste management, good documentation practices, document control, employee training policies, and gowning. Register to become a member or register your facility and receive access to these SOPs at www.aabmonline.org. There is no fee to register.

 

The Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) provides resources and expertise for development of investigational biological agents. The BDP supports feasibility through development and Phase I/II cGMP manufacturing plus regulatory documentation. The BDP has over 300 documents online that are available free for any investigator, company, or group developing biopharmaceuticals. These documents are useful to scientific, clinical manufacturing, quality control and quality assurance professionals.

Regulatory References

FDA Webinar Resources

  • OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn)

 

FDA Guidances

Websites

Gene Therapy Guidances

Guidance Documents

FDA Presentations

Related Links

US/International Organizations

Cell and Gene Therapy Programs

On-line Cell Therapy Resources

 

Perspective: Communications with the Food and Drug Administration on the Development Pathway for a Cell-based Therapy: Why, What, When, and How?
Feigal, et al.
Stem Cells Transl Med. 2012 Nov;1(11):825-32

 

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)

 

ISCT Beacon Suite of Navigational Tools

Cell Therapy Publications

Cell Therapy Books

NHLBI PACT Supported:

Cell Therapy Book 2nd Edition

Cell Therapy: cGMP Facilities and Manufacturing/2nd Edition/Coming Summer 2021
Edited by Adrian Gee, MIBiol, PhD

  • Fully updated and expanded second edition reflects all recent developments and changes in the field
  • Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more
  • Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc
This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and  shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for
academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

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). 

Click here for more details

(2021, 502 p. 97 illus., 79 in color. e-book/available soon; Hardcover)
eBook ISBN: 978-3-030-75537-9
Hardcover ISBN: 978-3-030-75535-5
eBook: $149 - Hardcover $199

All book orders are to be processed through Springer

Pre-order your eBook on-line
 

To pre-order a hard copy book, in US and Canada, please contact Customer Service at +1-800-777-4643, Latin America please contact Springer at +1-212-460-1500 (24 hours a day, 7 days a week)  Due to COVID restrictions, shipping of hard copy books may be impacted.  Please visit this page for details.

Second Edition Full Table of Contents:

Part 1.     Regulatory

  • Regulation of Cell Therapy in the United States 
  • Regulatory Landscape and Emerging Trends In Advanced Therapies Manufacturing: An EU Perspective 
  • Australian Cellular Therapy Regulations 
  • Landscape for Regenerative Medicine Manufacturing in Japan 
  • GLP Regulations for Non-clinical studies 
  • Ethical Considerations in Cell Therapy 
  • Investigational New Drug Applications for Cell Therapy Products
  • FDA Inspections 
  • Commercialization of Investigational Cell Therapy Products 

Part 2.   Quality Systems

  • The Meaning of Quality 
  • Development and Maintenance of a Quality Program
  • Quality Control of Cellular Therapy Products and Viral Vectors 
  • Quality Management Software – Q-Pulse 
  • Selection of Contract Manufacturing and Testing Organizations 

Part 3.     Facility Design

  • Introduction: Facility Design 
  • PACT CPFs: Design and Operation of a Multiuse GMP Facility at the City of Hope 
  • PACT CPFs : Design and Operation of a Multiuse GMP Facility at the University of Miami 
  • Design of a New Academic GMP Facility for Today and Beyond at the Dana-Farber Cancer Institute
  • Design and Licensure of an American Cord Blood Bank 
  • Indiana University Vector Production Facility (IUVPF) 
  • Qualification and Commissioning of a New GMP Facility 
Part 4.    Facility Infrastructure
  • Environmental Monitoring 
  • GMP Facility Cleaning and Maintenance 
  • GMP Documentation 
  • Process Validation 
  • Equipment Qualification 
  • Vendor Qualification and Supply Management 
  • Staffing, Training and Competency 

Part 5.    Product Management

  • Product Accessioning, Tracing and Tracking 
  • ISBT 128 in Labeling of Cellular Therapy Products 
  • Product Processing, Manufacturing and Administration 
  • Transport and Shipment of Cellular and Gene Therapy Products 
  • Regenerative Medicine: The Newest Cellular Therapy
  • Cellular Therapy Applications for COVID-19 

Part 6.    Professional Standards and Support Organizations

  • Professional Standards for Cellular Therapy: The Foundation for the Accreditation of Cellular Therapy (FACT) 
  • AABB Cell Therapy Standards
  • USP Standards for Cell-based Therapies
  • The Role of the National Institute of Standards Measurement Assurance for Cell Therapies
  • National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT) 
  • Financial Considerations for Academic GMP Facilities 
  • Governmental Support Opportunities for Cellular & Gene Therapies in the United States 

 


 

Cell Therapy Book 1st Edition

Cell Therapy: cGMP Facilities and Manufacturing
Edited by Adrian Gee, MIBiol, PhD

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)
ISBN: 978-0-387-89583-3
eBook: $109 - Hardcover $199

All book orders are to be processed through Springer

Order your e-book on-line

Print and complete this form to order a copy via postal mail or fax. Mailing information is included in the form.


AABB Publications:

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.
Significant changes to the 7th edition include:

  • Donor and patient informed consent requirements have been separated to provide more focused standards; this includes the expansion of Reference Standards 4.5A and 4.7A.
  • Enhanced Chapter 5 Process Control to divide the chapter into four distinct areas of focus: general process control, procurement activities, processing activities, and clinical activities.
  • New standards requiring specific time intervals depending on the nature of storage devices have been added in Standards 5.10.3.1 and 5.10.3.2.
  • Standards relating to in-utero and ex-utero cord blood collections have been added to the 7th edition to assist users as it relates to product labeling.
  • Donor evaluation standards focused on clinical activities have been added to this edition in Standards 5.24.1 – 5.24.1.2.

(2015, AABB, softcover, 154 pages)

(AABB, 2014, ISBN# 978-1-56395-913-4) 

Product Code: 153110

List Price: $200
AABB Member Price: $175


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
List Price: $89
AABB Member Price: $59


Cellular Therapy: Principles, Methods, and Regulations, 2nd edition
Edited by Ellen M. Areman, MS, SBB(ASCP), and Kathy Loper, MHS, MT(ASCP) 

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 
List Price: $225
AABB Member Price: $195
 


    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
    List Price: $192
    AABB Member Price: $156


    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 Funding Opportunities/Notices