Facilities for Cord Blood Processing: Gowning-Cleaning Procedures eCast (AABB Center for Cellular Therapies), November 16, 2017-November 16, 2019 
Description: Live and On-Demand eCast. This program will demonstrate administrative and engineering practices and policies required to ensure a safely sourced and a sterilely manufactured cellular product (cord blood) produced under aseptic processing conditions with optimum patient safety. This program’s objectives with be accomplished by discussion with these practices.

Microbiology Lab in Cell Therapy Facility: Operational Aspects and Merits On-Demand eCast (AABB Center for Cellular Therapies), May 11, 2017-May 11, 2019 
Description: Microbial studies and testing in cell therapy processing and/or banking facilities require different settings than clinical labs where specific activities expected to be performed such as validation studies of sterility test method for intended use, environmental microbial monitoring, disinfectants effectiveness studies, media fills to assure aseptic competency, etc. The focus of this program will be to present operational options for cell therapy processing/banking facilities to cover relevant microbial activities taking into consideration two operational models: onsite lab model and outside service model. Selection of appropriate model is governed by nature and size of work and availability of resources. Speakers will identify advantages and challenges related to each model and share their own experiences.

Training/Competency Program for CT Facilities (ISCT) 
Description: A strong training and competency program is an essential component of a cellular therapy laboratory. It ensures that regulatory requirements are met and that safe, effective products are supplied to patients. This webinar reviews potential problem areas in training and provides ideas for how to strengthen your training programs.

Potency Assays for Mesenchymal Tissue Regeneration (ISCT) 
Description: This webinar addresses how it is possible to establish potency assays for adult multipotent mesenchymal progenitors by distinct strategies dissecting both cellular differentiation and soluble factors release. Two distinct paradigms of cell-based regeneration are proposed, on one side bone regeneration and on the other side cardiac repair.

Clean Room Facilities: Cleaning Best Practices (ISCT)
Description: The Lab Practices Committee and ISCT sponsored a work group to survey internationally to determine routine sanitization and cleaning practices currently in use. This webinar discusses these survey results and outlines practices regarding appropriate facility/equipment cleaning and sanitization involved in the manufacture and processing of cellular therapy products.

CD34 Enumeration, How and When (ISCT)
Description: This webinar discusses the most important parameters and issues that influence final CD34 counts.

Stem Cell Processing Proficiency Testing (CAP) 
Description: Processing Facilities seeking proficiency testing for laboratory assays can enroll in the CAP Stem Cell Processing Survey (Code SCP). Procedures such as Absolute CD34, Bacterial Culture, Colony Forming Units (CFU), and Viability are included among others.

Specialty Operations and Clean Rooms (FACT), August 10, 2016
Description: This webinar was held live on August 10, 2016. Dr. Lawrence Lamb, from The University of Alabama Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program, gave an overview of specialty operations and clean rooms as they pertain to the FACT-JACIE 6th Edition Cellular Therapy Standards.

Part II – Implementing Changes from the 6th Edition FACT Cellular Therapy Standards: Processing Facility Requirements (FACT), April 15, 2015
Description: This webinar was presented by Richard Meagher, PhD, on April 15, 201. Dr. Meagher described changes to the 6th edition Processing Facility Standards and provided examples for effective implementation.

Thinking Beyond Efficacy – 4 Key Considerations for Achieving Commercial Success for Cell Therapies (ISCT) December 2015
Description: Efficacy is often the primary (and in some cases, sole) focus of most cell therapy companies. Without it, there is no therapy. However, as companies progress toward commercial manufacture with potential game changers (e.g., cures for cancer and diabetes), it is critical to think beyond efficacy, and consider the other 4 core attributes required to achieve commercial success. These key considerations include: manufacturability, cost of goods, reimbursement, and needle-to-needle logistics. During this webinar, we will discuss the importance each of these elements play in achieving commercial success, as well as key considerations and steps you must take to move cell therapies from the clinic to commercial-scale production.

Optimizing Cold Chain Logistics and Costs : Tips for Product Planning, Storage and Distribution (ISCT) November 2015
Description: Cold chain logistics are an essential and expensive requirement of most cell therapy products in clinical development and for commercialization. An increasing trend in the cell therapy industry is that products will need to be shipped at cold to ultra-cold temperatures for longer distances and between countries. Whether you plan to commercialize directly, or license to a commercial partner, optimizing your cold chain requirements and logistics costs during development can be an important factor in determining the ultimate pricing and profitability of your product. In this session, our speakers from BioLife, Celgene and Brooks will help to increase your knowledge of product development decisions that can influence your cold chain logistics requirements and also practical considerations for optimizing your cold chain distribution costs, while still meeting your quality and regulatory requirements.

Viability Determination of Cellular Therapy (ISCT) October 2015
Description: This webinar will describe the prevalent methodologies utilized and inherent deficiencies. It will describe the need and current status of alternative analytical methods that can aid in ensuring the consistency and comparability for cell viability specifications. The consideration of the selection and qualification of the proper viability assay is important in the early development process of CTPs. Its use in conjunction with purity and potency assays that are needed would ensure a quality product.

A Comparative Analysis of Serum and Serum-Free Cultures (hMSC) (ISCT) October 2015
Description: Since the early days of cell culture, serum has been an integral component in cell culture media by providing cells with a rich source of diverse nutrients. While serum may currently be acceptable for clinical human mesenchymal stem/ stromal cell (MSC) culture, securing a reliable source and supply of clinical grade serum is becoming an increasing concern. Furthermore, lot-to-lot variability of serum due to its complex mixture of undefined and variable constituents poses a challenge for translational and human clinical studies utilizing ex-vivo MSC culture. Therefore, a serum-free culture system can improve the generation of high quality cells without depending on serum, thus facilitating the development of more robust cellular therapies. This webinar will review the differences between serum-containing and serum-free MSC culture systems (such as autologous vs. allogeneic and application considerations) and when and how to implement the transition to a serum-free medium.

Media Use During Scale Up (ISCT) September 2015
Description: Media is one of the many critical components used during cellular manufacture. With so many types of media, so many sources of protein, and with such a plethora of growth factors available, identifying the ideal source of media early on during scale up is of the essence. In this webinar, two leading experts in cellular therapy will discuss their experiences with media use during scale up in two different settings of cellular manufacture: mesenchymal stromal cells and T cells. More specifically, they will discuss why media formulations matter, how the type of culture system matters, how media use impacts not only material costs but also labor and facility costs, and how to compare different types of media.

Utilizing a Risk-Based Approach for Development of Media Use in Cell Therapy Applications (ISCT) June 2015
Description: There have been numerous occurrences of contamination in biologics by adventitious agents over the years. As a result of these events, regulatory bodies and manufacturers such as Irvine Scientific have developed strict controls and processes that mitigate the risks of contamination. In this webinar we will present how utilizing a risk-based approach for media development ensures consistency, quality and facilitates scale-up transfer to clinical applications.

Measurement Assurance for Cell Enumeration (ISCT) April 2015
Description: In this webinar we will present our recent efforts in developing a new approach to improve the confidence of cell counting measurements independent of the measurement platform. Specifically, we will describe an experimental design and statistical analysis framework that can be used to evaluate the performance of a cell counting measurement process in the absence of a reference method, ground truth cell number, or reference material. The analysis produces a performance metric, which is derived from the basic assumptions that an accurate and reproducible counting method will have a proportional response to changes in dilution and be repeatable. This metric may be useful in characterizing the performance of a chosen cell count measurement process, and may be useful when making critical decisions on which measurement process to utilize for a given cell preparation.

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FACT Consulting

Accreditation Success Story

The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. The program has been FACT accredited for 10 years, and offers suggestions for large programs considering FACT accreditation. Read more