Available On-Demand on May 26

Learn how EVs are robustly produced from various hMSC (BM, AT & UCM) using a scalable serum-/xeno-free microcarrier-based culture platform, employing a single-use bioreactor and human platelet lysate culture supplement (UltraGROTM-PURE).

Achieving production of clinical EV doses will require cost-efficient, scalable, GMP ex-vivo expansion systems. Here we present a readily scalable, xeno-free MSC-EV expansion approach in a microcarrier-based bioreactor using human platelet lysate supplement;

• Producing MSC-derived EVs from various human tissue sources; bone marrow (BM), adipose tissue (AT), and umbilical cord matrix (UCM)
• Experience in a Vertical Wheel^TM Bioreactor
• Results using xeno-free UltraGRO^TM-PURE (FDhPL) supplement

Presenters:

Claudia Lobato de Silva, PhD
University of Lisboa
Portugal
 

Miguel de Almeida Fuzeta, PhD Candidate
iBB, IST, U. Lisboa
Portugal
 

Available On-Demand on May 26
Here we share use cases that demonstrate the Opto™ Cell Therapy Development workflow makes it possible to fully characterize individual T cells, correlate key characteristics, and directly link phenotype to gene expression at a single-cell level —all on the same T cells —enabling the development of more efficacious therapies.

Learning Objectives:
Understanding the underlying mechanisms of T cell differentiation and function is critical for developing effective therapeutics. However, T cells are extremely heterogeneous and have variable responses to stimulation. This makes predicting specific Tcell responses extremely difficult. To identify effective T cells within a heterogeneous sample, scientists must be able to characterize T cells at the single-cell level. However, most existing single-cell methods are destructive and prevent the correlation of cytokine secretion with other functional parameters like cytotoxicity or gene expression. Here we share use cases that demonstrate how the Opto™ Cell Therapy Development workflow makes it possible to fully characterize individual T cells, correlate key characteristics, and directly link phenotype to gene expression at a single-cell level—all on the same T cells—enabling the development of more efficacious therapies.

Presenter:

Jim Lovgren
Berkeley Lights, Inc.
USA
 

Available On-Demand on May 26

BioLegend is a global trusted partner of premier research institutions, biotechnology, and pharmaceutical companies. Our cutting-edge tools provide reproducible results in immunology, oncology, neuroscience, stem and proteogenomics.

During this presentation, learn:
• To show how serum replacements can benefit the immunotherapy field.
• About our new product, Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP. Designed to work in combination with multiple basal media, Cell-Vive™ performs similarly or better than human AB serum, for both T and NK Cells. 

Presenter: 

Vanda S. Lopes, PhD
Scientist III
BioLegend
USA

Available On-Demand on May 26
Application of cellular reprogramming supported by our opti-ox technology, enables precise and scalable manufacturing of human cells for therapeutic applications.

Learning Objectives:
• Introduction to novel technology that allows consistent, fast and scalable manufacturing of human cells from hiPSCs.
• Understanding the role of transcription factors in cell reprogramming.
• How this applies to cell therapy.

Presenter

Mark Kotter, MD
CEO & Founder
bit.bio
UK
 
 

Available On-Demand on May 26
MSC therapies are being pursued in high-impact diseases, but scalability is still a challenge. At Catalent, we implement innovative manufacturing, fill & finish methodologies to accelerate the path to commercial for MSCs and other allogeneic modalities.

Learning Objectives:
• Understand challenges associated with scalability of MSCs
• Catalent’s solutions to accelerate commercial-scale manufacturing of MSC and other allogeneic therapies
 

Presenter

Jef Pinxteren
Catalent Cell and Gene Therapy
USA
 
  

Available On-Demand on May 26
Learn how Catenion can support you to look into the complexity of AAV-based gene therapy and identify new indications that fit the unique technological profile of your gene therapy platform

Learn about:
• Overview of AAV-based gene therapy, including challenges and potential solutions.
• Therapeutic Expansion – Learn how to conduct a systematic database-driven selection of new indications in the gene therapy space

Presenter:

Pascal Joly, PhD
Principal
Catenion
Germany

Available On-Demand on May 26
CAR-T developers are rushing to solve technical hurdles and bring new products to market. Listen to a technical expert from CCRM’s PD team describe how our capabilities can help you address challenges and succeed in this competitive space.

Viewers will understand how to de-risk your CAR-T process by:
• developing closed systems
• utilizing automated processes
• establishing modular manufacturing approaches & optimizing each unit operation

Presenter:

Megan Logan, BASc, MASc
CCRM
Canada
 
 
  

Available On-Demand on May 26

In identifying a manufacturing partner for your cell-based therapy, several options exist for early phase clinical translation. A major decision point is whether to work with a commercial CDMO or an academic/hospital-based supplier. Which of these will enable better clinical integration and patient care? How will these suppliers scale with your program over time? Associate Professor Dominic Wall, Interim CEO and Chief Scientific Officer at Cell Therapies Pty Ltd and Executive Director of Business Ventures at the Peter MacCallum Cancer Centre, will provide his perspectives on these challenging questions.

Cell Therapies Pty Ltd (CTPL) is one of the most experienced contract manufacturers of global cellular therapy products. Since 2003, CTPL has provided GMP manufacturing services to meet international regulatory standards for clients. We operate a 10-cleanroom facility in Melbourne that holds commercial and clinical trial manufacturing licenses by Australia’s TGA.

Learning Objectives of this session is understanding the advantages and challenges in working with an academic or hospital manufacturer vs a commercial CDMO, especially with respect to:
- Clinical integration
- Patient care
- Scalability and infrastructure
- Cost drivers – budget vs growth
 

Presenter:

Dominic Wall, PhD FFSc (RCPA)
Cell Therapies Pty Ltd
Peter MacCallum Cancer Centre
Australia
 
 

Available On-Demand on May 26
Dr. George Muschler Describes the Cell X automated cell culture system. The Cell X Device facilitates rigor and reproducibility in cell manufacturing and process development by integrating key function of cell culture into a single automated robotic device. The device combines large-field-of-view imaging, automated image analysis, colony picking/pruning, liquid handling, and data acquisition, annotation, and documentation to facilitate rapid process optimization and reproducible manufacturing with no technician bias. Here we describe the device and illustrate its utility in an application selecting stem cells with high potency for a targeted application.

Presenter:

George Muschler, MD
Cleveland Clinic
USA
 
 
  

Available On-Demand on May 26

The Cryoport Elite™ multi-use shipper is aimed to sustain consistent temperatures during transit for longer than 4 days, prevents accidental openings during shock events, and provides real-time temperature monitoring on the outside of the shipper.

Presenter:

Lindsay Belcher, MBA
Vice President, Business Development, Americas
Cryoport Systems
USA

Available On-Demand on May 26

Cymerus™ is a clinical stage, iPSC-derived therapeutic stem cell platform technology.

Learning Objectives:

• Rationale and advantages of iPSC-derived therapies
• Details of first completed clinical trial worldwide with iPSC-derived cells in any disease
• Overview of broad ongoing clinical development pipeline
• Partnering opportunities

Presenter:

Kilian Kelly, MRPharmS, PhD
Chief Operating Officer
Cynata Therapeutics Limited
Australia

Available On-Demand on May 26
Stem cells-derived exosomes are of great interest as therapeutic tools. Learn about the potential of stirred-tank bioreactors for the reproducible production of large amounts of exosomes, which is required to explore this application.

Learning Objectives:
• Learn about the potential of stem cell-derived exosomes in therapeutic applications
• Understand, how stirred-tank bioreactors facilitate the production of large amounts of exosomes
• Learn, how bioreactors can help increase reproducibility of exosome production
• Get to know the DASbox® Mini Bioreactors System equipped with BioBLU® Single-Use Vessels, which was successfully used for exosome production

Presenter:

Dr. Aurelie Tacheny
Application Specialist-Cell Handling
Eppendorf Application Technologies SA
Belgium
 
 

Available On-Demand on May 26
Mesenchymal stem or stromal cells (MSCs) have long been proposed as a potential cell source for musculoskeletal regeneration. Monolayer expansion of adherent MSCs is an attractive alternative strategy due to the relative ease with which the cells can be isolated, e.g. bone marrow aspirate, and the ability to generate large cell numbers that can then be implanted. However, this process is fraught with difficulties as it is known the expansion process can lead to major changes in cellular function^1,2. Whether this is due to changes in cell behavior during expansion (phenotypic drift), or whether it is due to the expansion conditions preferentially selecting for a subpopulation is unclear, with data suggesting both may be possible. Multicolor barcode lentivirus labelling has shown that while the initial cell population is extremely heterogeneous, a smaller number of clones become dominant during expansion³. Once expanded, donor variation is still a major challenge, with markers predictive of function being limited.  Commonly used CD markers do not provide an indication of function, which limits their use. We have developed a marker of chondrogenic potential that accurately predicts the in vitro chondrogenic potential of monolayer expanded human bone marrow derived MSCs. The mRNA ratio of TGFb-RI/TGFb-RII at the time of cell recovery from the tissue culture plastic reliably predicts chondrogenic potential⁴. Furthermore, a transient increase of the ratio with siRNA knockdown of TGFb-RII reproducibly recovered the chondrogenic differentiation ability of non-responsive MSCs. This marker allows screening of monolayer expansion conditions, to guide culture optimization. We show that serum free commercially available media offers comparable performance of monolayer expanded human bone marrow MSCs compared with gold standard medium containing FBS and FGF2. Additionally, adapting monolayer expansion conditions during the last few days of culture can prime cells to be more receptive to differentiation. Identification of markers predictive of MSC differentiation potential can improve patient stratification leading to more reproducible results.

Presenter:

Martin J. Stoddart, PhD, FRSB
AO Research Institute (ARI)
USA
 
 

Available On-Demand on May 26
Introducing the Aura CL to detect, quantify and ID, stability, purity and subvisible particles in cell and gene therapy products. The Aura CL quantifies product quality in minutes, right out of the box without any complicated machine learning algorithms.

Learning Objectives:
• Learn cell and gene therapy-specific techniques for:
• Particle analysis
• Product purity
• Product quality

Presenter:

Bernardo Cordovez, PhD
Chief Science Officer
Halo Labs
USA
 
  

Available On-Demand on May 26
Chimeric antigen receptor (CAR) T cell therapy has proven to be very successful immunotherapies to fight against liquid tumors and is quickly expanding to solid tumors. However, a lot is still unknown in terms of exactly how these re-engineered cells will behave once reinfused into a patient, including efficacy and potential side-effects. Therefore, the biggest challenges are how to evaluate the quality of CAR-T cells and how to predict their in vivo behaviors once reinfused into a patient.

We review single-cell polyfunctional profiling results from several different sets of pre-infusion CAR-T samples, including anti-CD19 CAR-T samples from both Kite Pharma (Gilead) [1] and Novartis Pharmaceuticals [2], GoCAR-T cell products from Bellicum Pharmaceuticals [3], and Bispecific CD19/22 CAR-T cells from the NIH [4]. trimeric APRIL-based CAR-T cells targeting both BCMA and TACI from MGH [5].
 

Presenter:

Victor Tek
IsoPlexis
USA
 
 

Available On-Demand on May 26
This talk discusses industrialized cell therapy manufacturing and how the ekko™ Acoustic Cell Processing System addresses the entire manufacturing workflow.  

Learning Objectives:
• The best practices for the industrialization of cell therapy manufacturing
• How acoustic cell processing technology addresses the needs of the entire manufacturing workflow
• How process optimization can be supported through use of the ekko™ Architect software, our protocol development tool for the ekko™ Cell Processing System

Presenters:

Samantha Sbardella
MilliporeSigma
USA
 

Robert Scott
MilliporeSigma
USA

Available On-Demand on May 26
Custom cell culture media improves viability, transfection, and cellular potency, while reducing variability. AI-based media formulation and customization expedites the improvement of cell therapy development from bench to bioreactor.

Learning Objectives:
• Single cell-media components can affect transfection efficacy, potency, and yield of your cell therapies.
• Improvement of black-box proprietary off the shelf media formulas, critical for cell-performance, is a manual process requiring a high degree of experimentation and validation.
• Media variability has been demonstrated between suppliers. Modification on top of unwanted variability amplifies the problem. Variability creates non-scalability. Avoid it.
• Design and own your own formulations and eliminate variability, with consistent, high-quality supply of materials to scale with your stage of development.
• Eliminating variability supports scalable volumes, from benchtop to bioreactor.
• Transparency is critical in every stage of cell culture media development from formulation to supply.
 

Presenters:

Brad Taylor
Nucleus Biologics
USA
 
 

Available On-Demand on May 26
Obatala Sciences and Louisiana BIO will present a suite of commercialized human derived products for tissue modeling with large scale clinical grade applications in wound repair.

Learning Objectives:
• To describe optimal features for products that support human tissue modeling and injury repair
• Discuss the value of human adipose-derived matrices for tissue repair applications in skin, bone, and connective tissues
 
Presenters:

Trivia Frazier, PhD, MBA
Obatala Sciences, Inc.
USA
 
 

Available On-Demand on May 26
Pluristyx contract cryopreservation development will help your company successfully tackle the challenges of harvest, formulation, freezing, storage, shipping, and delivery from early ATMP development all the way to commercialization.

We will demonstrate that:
• Cryopreservation process development is often left to the last minute
• Successful cryopreservation is critical to efficient product development
• Cryopreservation development can be integrated into the continuum of process development
• The required components for a successful cryopreservation process
• Pluristyx can develop and optimize your custom cryopreservation workflow
 
Presenters:

Brian Hawkins, PhD
Pluristyx
USA
 
 

Available On-Demand on May 26
Cell-based therapies continue to face challenging and time-consuming regulatory requirements.  RoosterBio, Inc., a privately held cell manufacturing platform technology company, has streamlined this path to clinical manufacturing, leveraging the productivity of our industry leading Human Mesenchymal Stem/Stromal Cells (hMSCs) bioprocess systems to help build cGMP processes for specific product. There is a growing therapeutic need to scale-up rapidly to achieve cells and extracellular vesicles (EV) in large quantities with lower costs and therapeutic quality. RoosterBio’s sustainable design for hMSC Bioprocess Systems accelerates implementation of fed-batch bioreactor scale-up and can be translated in large scale bioreactor-based cells and EV production. The acceleration towards clinical is also made to be possible by adopting RoosterBio’s translation friendly and CliniControl consumables. These approaches revolutionize how regenerative medicine products are developed, clinically translated, and commercialized.

Learning Objectives:
• Understand RoosterBio’s products and capabilities positioned to enable customers for their hMSC based therapeutic needs
• Insight in RoosterBio’s Upstream and Downstream Process Development for scalable cell production

Presenters:

Theresa D'Souza, PhD
RoosterBio, Inc.
USA
 
 

Available On-Demand on May 26
Description Forthcoming

Presenter:

Rahul Singhvi, ScD, MBA
Resilience
USA
 
  
 

Available On-Demand on May 26
Data analytics helps cell manufacturers and hospitals gain more visibility and control to the cell collection process, which can improve the quality of the starting material. Through customized and comprehensive solutions, learn how Terumo Blood and Cell Technologies cell collection services collaborates with its customers to advance cell and gene therapies for patients around the world. Watch this 10-minute presentation now!

Available On-Demand on May 26
We present the results of an extensive benchmark of cell culture technologies for hiPSC expansion. We compared standard 2D culture in flasks and spheroid culture in bioreactors with the C-Stem technology.

Learning Objectives:
• Comparing expansion factors & overall scalability of iPS cell culture systems
• Comparing the output of iPS technologies in terms of cell quality

Presenters:

Fabien Moncaubeig, PhD
Chief Development Officer
TreeFrog Therapeutics
France

Maxime Feyeux, PhD
Chief Scientific Officer and Co-Founder
TreeFrog Therapeutics
France

Kévin Alessandri, PhD
Chief Technical Officer and Co-Founder
Treefrog Therapeutics
France
  

Available On-Demand on May 26
VectorBuilder’s intuitive design studio opens the window to flexible custom vector construction, manufacturing and virus packaging (AAV, AV, LV) to meet new challenges in the development of gene therapies.

Learning Objectives:
•Introduction to VectorBuilder’s intuitive design studio
•Easy design of vectors
•Applications in cell and gene therapy
•Virus production for research and clinical trials

Presenters:

Thomas Jonsson, PhD
Territory and Business Development Manager
VectorBuilder Inc.
USA

Vladimir Ivosev, PhD
Sr. Territory Manager
VectorBuilder GmbH
Spain

Stella Gideon
Southeast & TX Sales Representative
VectorBuilder Inc.
USA
  

Available On-Demand on May 26
WellSky Biotherapies Lab drives process management for Advanced Therapy Medicinal Products (ATMPs) through streamlined manufacturing, improved materials management, on-demand analytics, systems interoperability and enhanced quality control.

Attendees of this showcase will:
•Learn about Biotherapies, WellSky's software solution for cell and gene therapy
•Understand how Biotherapies addresses supply chain management
•Understand solution configurability across donor management and eligibility determination, collection / apheresis, and processing / manufacturing platforms and protocols
• Understand how the solution manages equipment and supply inventory
• Understand label printing (i.e. ISBT-128) capabilities
• Learn how the solution supports clinical trials / research studies
• Understand solution interface capabilities
• Learn how the system makes data actionable

Presenters:

Jonathan Wofford
General Manager - Biotherapies
WellSky
USA

Available On-Demand on May 26
The evolution of advanced therapies into viable treatment relies on a robust supply chain strategy, linking donor to manufacturer and manufacturer to patient. Find out how World Courier, with key partners, can deliver cryogenic transport and storage that can scale up and out to support global commercialization goals for allogeneic therapy developers.

Presenter:

Andrea Zobel
AmerisourceBergen World Courier
Senior Director, Personalized Supply Chain
Germany