January 17
12pm ET

Ancillary Materials Used in Cell Manufacturing
Organized and hosted by United States Pharmacopeia
$100 for ISCT members/$150 non-members. Click here for offer code.

February 8
12pm ET

Volume reduction technology for large scale harvest or post-thaw manipulation of cellular therapeutics
Organized by the CC

Febrary 22
12pm ET

Clean Room Facilities: Cleaning Best Practices
Organized by the LPC

April 11
12pm ET

Novel Methods for reducing CoGs in Autologous Processing
Organized by the CC

May 9
12pm ET

Quality control of  manipulated and cryopreserved grafts
Organized by the LPC

May 25
9am ET

Potency Assays for Mesenchymal Tissue Regeneration
Organized by the EU LRA

June 20
12pm ET

The Circular of Information Basics: what it is and what it is not
Organized by the NA LRA

September 19
12pm ET

Best Practices in Process Development
Organized by the CC

September 26
12pm ET

ISBT Implementation: What to do and what not to do
Organized by the LPC

October 24 Postponed until further notice
12pm ET

Comparability
Organized by the CC

November 7
12pm ET

Training/Competency Program for CT Facilities
Organized by the LPC

November 21 Postponed until January 30th, 2013
12pm ET

How to Meet GMPs for Phase 1 Trials
Organized by the NA LRA

November 28
12pm ET

Electronic Records: What it means to be 21CFR part 11 compliant
Organized by the NA LRA

December 12
12pm ET

ISCT: Membership has its benefits.
Organized by ISCT Head Office

Early Registration

Late Registration

ISCT Members

$90

$105

Non-ISCT Members

$105

$120

Price

ISCT Members

$70

Non-ISCT Members

$85

Volume reduction technology for large scale harvest or post-thaw manipulation of cellular therapeutics

Organized by the Commercialization Committee

February 8, 2012
12:00pm ET to 1:00pm ET

Chair: Wouter Van't Hof, Director of Regenerative Medicine, Athersys Inc.

Speakers:

Dr. Harvey Brandwein, Pall Life Sciences, Vice President
Dr. John Chapman, Stem Cell Partners

Registration: (Early Deadline February 1st, Late Deadline: February 6th)

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

The manufacturing processes for cell therapy products (CTPs) can face a variety of challenges, including variability in the nature, source and intended uses of the products. To make the process amenable to later stage clinical testing and the product commercially viable, scale-up routinely receives significant emphasis in development of manufacturing platforms. Today we will discuss two examples of available of new technologies for cell product manipulation that come into play during and after successful scale up, namely at the time of banking and at the time of administration.

Filtration technology has originally focused mainly on isolation of biologicals such as monoclonal antibodies away from the cells that produce them. With cell therapy coming of age, there is increased interest in adapting filtration procedures towards isolation and purification of the cells themselves as the therapeutic product, bringing along its own specific set of opportunity and challenges.

In addition, new technologies are required for manipulation of large cell amounts thawed from cryo-preserved product doses, to enable routine clinical administration in a safe, reproducible and relatively quick and simple manner. New point of care devices are in development to permit harvesting, washing and concentration of large quantities of cells into any desired configuration.

Clean Room Facilities: Cleaning Best Practices

Organized by the Laboratory Practices Committee

February 22, 2012
12:00pm ET to 1:00pm ET

Chair: Federico Rodriguez, MT(ASCP)SBB, Manager Cell Therapy Laboratory, San Diego Blood Bank

Richard Meagher, Associate Research Professor of Medicine, Northwestern University Feinberg School of Medicine

Andrew Havens, Quality Assurance Manager, The Evelyn H. Griffin and the Judith R. Hoffberger cGMP Facilities Program of Regenerative Medicine

Registration (Early Deadline February 15th, Late Deadline February 20th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

The Lab Practices Committee and ISCT sponsored a work group to survey internationally to determine routine sanitization and cleaning practices currently in use.  The survey asked questions regarding cleaning frequency by product and lab type, cleaners and materials used.  Additional questions concern environmental monitoring, personnel practices, PPE and procedures for equipment cleaning. 

There is a sizable publication gap in our industry regarding these subjects.  It is the committee’s goal to create a published guidance based on these results and eventually present it to the FDA for review and hopefully obtain guidance from The Agency. 

This webinar will discuss these survey results and outline practices regarding appropriate facility/equipment cleaning and sanitization involved in the manufacture and processing of cellular therapy products.  We will also offer suggestions and provide best practices from the wide variety of facilities who responded to the survey.

The desire is to generate discussion within attending facilities to aid them in  cleaning procedure improvement and to guide the industry as a whole on how to perform these important tasks more effectively.

Novel Methods for reducing CoGs in Autologous Processing

Organized by the Commercialization Committee

April 11, 2012
12pm ET to 1:00pm ET

Chair: Thomas Brieva, Celgene

Speakers:

Juan Vera, MD, Assistant Professor, Center for Cell and Gene Therapy (CAGT), Department of Medicine, Baylor College of Medicine

Rosemary Drake, PhD, Chief Scientific Officer, TAP Biosystems

Registration (Early Deadline April 4th, Late Deadline April 9th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

How cost effective is automation for autologous cell processing?
Presented by: Rosemary Drake

The labour intensive nature of cell processing and testing, together with management and tracking of individual patients' samples means that the cost of goods for autologous cell therapies can be high. Scaling up cell therapy manufacture requires significant investment in skilled staff and facilities, but this can be greater for autologous cell therapies since multiple clean room suites (with associated staffing) are required to ensure adequate segregation of many individual batches - effectively one batch per patient.

As autologous cell therapies come to market, there is a need to address these COG issues to ensure commercial success. Automation can significantly reduce manual processing, since it is now possible to automate many routine cell processing tasks with high reproducibility. Processes can be efficiently and accurately recorded, so saving considerably on the operator time spent on this task. Automation can potentially also reduce facilities investment cost (since fewer clean room suites are required). This webinar will discuss the contribution of automation to reducing COG for autologous cell therapy manufacture.

Optimized Manufacture of Antigen-specific T cells
Presented by: Juan Vera

Although the administration of ex-vivo activated and expanded antigen-specific cytotoxic T lymphocytes (CTLs) is being increasingly associated with promising clinical results, there are several limitations to the extension of this approach beyond the research arena. A major practical constraint is the complexity associated with producing large number of cells using conventional production methods. Traditionally our group and others have cultured virus- and tumor-directed T cells in 2cm² wells of tissue culture treated 24-well plates. However, the restricted culture media:surface area ratio (1ml/cm²) required to facilitate gas diffusion, limits the supply of nutrients, which are rapidly consumed by proliferating T cells. Consequently, acidic pH and waste build-up rapidly impedes cell growth and survival. Therefore, the only alternative for cell propagation is frequent re-seeding and medium exchange which increases the frequency of manipulation required with a concomitant increase in the risk of contamination. Thus, we sought to optimize our antigen-specific T cell culture process which led us to evaluate a novel cell culture device (gas-permeable cultureware (G-Rex)), developed by Wilson Wolf Manufacturing, and in which O₂ and CO₂ are exchanged across a gas permeable silicone membrane at the base of the flask. Because gas exchange occurs from below, an increased depth of medium above is possible, providing more nutrients required by the cells while waste products are diluted, thus not adversely affecting cell growth. These optimal culture conditions provided by the G-Rex result in improved cell viability and increased final cell numbers without increasing the number of cell doublings, and decreasing the feeding frequency and the number of manipulations required.

Purchase or Access the Recording (FREE for members 3 months post event)

Quality control of  manipulated and cryopreserved grafts

Organized by the Laboratory Practices Committee

May 9, 2012
12pm ET to 1:00pm ET

Chair: Michele W. Sugrue M.S., MT(ASCP)SBB, Coordinator, Research Programs
Division of Hematology/Oncology, Department of Medicine, University of Florida Shands Cancer Center, USA

Speakers:

Ulrike Koehl, PhD, University Hospital, Paediatric Haematology and Oncology, Head, Lab Stem Cell Transplantation and Immunotherapy, Frankfurt, Germany

Lubomir Arseniev, MD, Site Manager, Head Quality Control, Cellular Therapy Centre - Medical School Hannover, Germany

Registration (Early Deadline May 2nd, Late Deadline May 7th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

The quality control of manipulated and/or cryopreserved grafts has been a hot topic since the beginning of the haematopoietic cell transplantation. Both scientific societies and competent authorities are investing more and more efforts with regard to establishing essential requirements and standardisation of manufacturing and quality control processes.

Where donor eligibility approval is quite well defined, a variety of further questions still seem to be not formally established: overall and subset cell counting, potency assays, control algorithm, e.g. in process and final controls etc.

This webinar will provide information on validation requirements and procedures for quality control methods as well as on quality control data of manipulated (selection, depletion) and/or frozen grafts. In order to improve release criteria for new cellular therapy products (e.g. Biologics or ATMP) multi-colour flow cytometry analyses will be provided. This webinar will discuss the specific challenges and outline practices regarding appropriate definition of a quality control panel. The goal of this presentation is to further pursue  discussion within this topic.

Purchase or Access the Recording (FREE for members 3 months post event)

Potency Assays for Mesenchymal Tissue Regeneration

Organized by the European LRA

May 25, 2012 (NOTE DATE CHANGE)
9am ET to 10am ET

Chair: Massimo Dominici, MD,  Assistant Professor, University of Modena

Speakers: Massimo Dominici, Wilfried Dalemans, PhD, TiGenix NV, Bob Deans, PhD, Athersys Inc.

About the Webinar:

One fundamental aspect in translating pre-clinical results into safe and performing cellular therapy products during cell production and at the time of release is to establish dedicated potency assays.

These tests should address the following questions “How is it working? Will it always work? Can you measure that?” providing reproducible and standard insights capable to measure biological activity for the intended use.

The IHC guideline Q6B specifies that a potency assay shall be “the measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product which is linked to the relevant biological properties”. Moreover, it is stating that “Potency is the quantitative measure of biological activity based on the attribute of the product which is linked to the relevant biological properties” additionally adding that “A correlation between the expected clinical response and the activity in the biological assay should be established in pharmacodynamics or clinical studies.”

While this is quite established for defined molecule-based therapies with precise mechanisms, potency assays for cell-based therapeutics has been historically challenging since living cells act by a series of factors sometimes difficult to define.

During this webinar we will address 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 will be proposed, on one side bone regeneration and on the other side cardiac repair. These experiences will be shared by either an academic lab or industry, providing evidence on the feasibility in establishing potency assays for adult mesenchymal progenitors.

Wilfried Dalemans, PhD
Chief Technology Officer, Tigenix NV, Belgium

“Potency assay development for an autologous cartilage repair cell product”

• ChondroCelect, an approved ATMP for cartilage repair
• Potency, general considerations and challenges for an autologous product
• Potency of expanded cartilage cells, looking from different angles
• Potency development for a routine setting

Massimo Dominici
Member ISCT EU LRA Committee, ISCT CAT-EMA RepresentativeUniversity of Modena and Reggio Emilia, Modena, Italy

“Developing potency assays for bone regeneration at academic level”

• BM-MSC in Phase II trial-REBORNE CONSORTIUM - FP7 EC PROJECT
• Development of potency assay by molecular analyses
• Development of potency assay by 2D cultures
• Development of potency assay by 3D cultures

Bob Deans
Chair ISCT Commercialization Committee
Executive Vice President of Regenerative Medicine, Athersys, Inc , USA

“Adherent Stem Cells in Treatment of Ischemic Cardiovascular Injury: Angiogenic Potency Assays”

• Bone marrow stem cells in Phase I/II development
• Establishing pass/fail criteria for lot release
• Secretion of VEGF, IL8 and CXCL5 (ELISA)
• MultiStem(R), and adherent stem cell product

Purchase or Access the Recording (FREE for members 3 months post event)

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Topic: The Circular of Information Basics: what it is and what it is not

Organized by the North American LRA

June 20, 2011
12pm ET to 1:00pm ET

Chair: Nancy Collins, PhD, Clinical Assistant Professor, Dept. of Medicine, University of Toledo, USA

Speakers: Nancy Collins and Grace Kao, MD, Dana-Farber Cancer Institute, USA

Registration (Early Deadline June 15th, Late Deadline June 19th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

At the end of the webinar, participants should be able to:

1. Understand the regulatory requirement for the Circular of Information for cellular products, its history, and clinical use.
2. Understand the process of COI revision and approval by the participating organizations
3. Understand the current status of the most recent revision of the COI and its major divisions.
   

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Best Practices in Process Development

Organized by the Commercialization Committee

Sponsored by:

September 19, 2012
12pm ET to 1:00pm ET

Chair: Jon Rowley, Director, Cell Therapy R&D, Lonza Walkersville

Speakers: Jon Rowley, Director, Cell Therapy R&D, Lonza Walkersville

Registration:

This educational webinar is provided complimentary courtesy of Lonza.

About the Webinar:

As Cell Therapy is evolving as a field and technical discipline, bioprocessing strategies and technologies are being utilized to scale-up, scale-out and streamline manufacturing processes to position them for commercial success.  However, Process Development is a discipline learned on the job and there are few texts that cover many of the best practices used in the field – and fewer available that discuss Cell Therapy-specific requirements.

This educational webinar will cover several best practices in Cell Therapy Process Development, and provide a framework in which to help in designing highly effective multi-year process development and manufacturing plans that span across clinical development and through to commercialization.  The goal is to achieve commercially relevant manufacturing processes that deliver a product at costs that allow for commercial success.

Purchase or Access the Recording (FREE for members 3 months post event)

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ISBT Implementation: What to do and what not to do

Organized by the Lab Practices Committee

September 26, 2012
12pm ET to 1pm ET

Chair: Sara Murray, HCP Laboratory Manager, OHSU

Speaker: Leigh Sims Poston, Cytotherapy Laboratory Program Supervisor, University of Viginia

Registration (Early Deadline September 19th, Late Deadline September 24th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

The Fifth Edition FACT standards state:

• D7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions and,

• D7.1.2 If the Processing Facility has not fully implemented ISBT 128 technology, and implementation plan for the usage of ISBT 128 coding and labeling shall be in place.

In the Cellular Therapy field there is a growing need for productive software that permits a user to reference information, create documents and generate queries. Software’s ability to aggregate, link, harmonize and analyze data is essential when looking at improving transplant patient outcomes. There is also a growing need for software that meets the demands for regulatory compliance and demands of quality assurance within the Cellular Therapy field.

Software specifically designed for Cellular Therapy Facilities may be purchased directly from commercial software companies who specialize in medical informatics. Companies such as STEMSOFT and ComprehensiveBMT are examples of these. Facilities may also build their own unique databases using software provided by their Institution’s Microsoft Package. Examples of these include Microsoft Excel, Microsoft Sql Server and Microsoft Access.
There are a multitude of reasons to choose a specific type of software.  Decision making often involves the software’s objectivity, functionality, diversity, user friendliness, presentation, overhead cost, etc.

The learning objectives for the webinar are:

1. Explain why switching to ISBT 128 compliant terminology is important
2. Explain where and how to start the implementation process
3. Define what equipment, materials and software will be needed
4. Describe the set up of an implementation calendar
5. Describe the keys to success in transition from current labeling system to ISBT 128 compliant labeling system
6. Supply references and contact information as guidance for implementation
7. Discuss what type of software different Cellular Therapy Facilities Use
8. Discuss the pros and cons of software choice

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

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Comparability

Organized by the Commercialization Committee

Date: TBD
12pm ET to 1pm ET

Chair:

Knut Niss, PhD, EMD Millipore, Chair, ISCT Process and Product Development Sub-Committee

Speakers: TBD

Registration (Early Deadline October 17th, Late deadline October 22nd):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

TBD

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

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Training/Competency Program for CT Facilities

Organized by the Laboratory Practices Committee

November 7, 2012
12pm ET to 1pm ET

Chair:  Steve Konings, Froedtert Hospital

Speakers: Andrew Patmos, Cell Processing Technologist, Dana Farber Cancer Institute and Karen Snow, Quality Assurance Officer, Bone Marrow Transplant Program, Massachusetts General Hospital

Registration (Early Deadline October 31st, Late deadline November 5th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

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.  The goal of this webinar is to review potential problem areas in training and provide ideas for how to strengthen your training programs. In addition, this webinar will focus on:

-Recognition of new concepts that make a cellular therapy laboratory different
-Highlighting problem areas in training and maintenance of competency
-How to design an effective training program.
-The importance of having an orientation component for new staff, with examples of what to include in an orientation program.
-How to document training and competency activities.
-How to assess competency on an annual basis in a way that meets regulatory requirements and is sustainable.
-Providing ideas on how to get staff members involved in their competency assessments.

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

Topic: How to Meet GMPs for Phase 1 Trials

Organized by the North American LRA

November 21, 2012 Postponed until January 23rd, 2013
12pm ET to 1:00pm ET

Chair and Speaker: Debe Griffin, MSc, Quality Assurance Manager for Cellular Therapies, University of Pittsburgh Cancer Institute, USA

Speaker: Lisa H. Butterfield, Ph.D. Associate Professor of Medicine, Surgery and Immunology Director, UPCI Immunologic Monitoring and Cellular Products Laboratory University of Pittsburgh

Registration (Early Deadline: January 16th; Late Deadline: January 21st):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

1. Review the FDA Guidance for the statutory GMPs for Phase 1 clinical trials
2. Discuss changes required whether going from full GMP or from non-GMP processing

1. Know where to find statutory GMP and the Guidance
2. Understand the implications to a facility and its processing/manufacturing
3. Document the review of the requirements and any changes made to a facility’s process

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

Topic: Electronic Records: What it means to be 21CFR part 11 compliant

Organized by the North American LRA Committee

November 28, 2012
12pm ET to 1:00pm ET

Speakers: Karen Nichols, Esq. RAC, VP Regulatory and Quality, OvaScience, Inc. and Bill Janssen, PhD, Director, Cell Therapies Facility, H. Lee Moffitt Cancer Center, USA

Registration (Early Deadline November 21st, Late Deadline November 26th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

Overview of 21 CFR Part 11

1. Basic rule
2. Key concepts from preamble

Learning Objective: basic understanding of the rule and its background- value of using preambles generally to understand FDA regulations

Defining predicate rules and e-sign

1. Literal examples from 21 CFR (such as 21 CFR 211.182)
2. Practical examples (requirement to have batch records)

Learning Objective: an understanding of what predicate rules are, where to find them, how they drive Part 11 implementation

Creating and Executing a Part 11 Compliance Plan

1. Enterprise systems vs. local systems

Learning Objective: identifying steps and tools for putting a compliance plan in place

Case Studies

1. Learning Mgt. System
2. ERP System
3. EDMS

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

Join Us For a Complimentary, Informational Webinar on
ISCT Membership and Benefits.

Date: Wednesday, December 12th, 2012

Time: 9:00 AM PT, 11:00 AM CT, 12:00 PM ET, 6:00 PM CET (Europe)

Cost: FREE!

Speakers:

Kurt C. Gunter, ISCT President

Steve Konings, ISCT Member, and Member of ISCT Lab Practices
Committee

Brian Poole, Manager, Industry and Scientific Relations
(ISCT Head Office)

Rony Ganon, Member Services Administrator
(ISCT Head Office)

Register Now