Cell Therapy Manufacturing: Regulations and Facilities
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This document discusses the regulatory and manufacturing challenges of cell therapy products. It notes that cell therapies must be aseptically processed but cannot be fully sterilized like traditional drugs. The challenges include controlling differentiation of stem cells into the desired target cell type, developing potency assays, and dealing with variability in biological materials. Manufacturing challenges include developing aseptic processing methods, handling adventitious agents, and scaling up production capacity for either autologous or allogeneic use. Larger centralized facilities face quality oversight and logistical issues, while smaller regional facilities could better concentrate expertise, quality, and handling of incoming/outgoing cells and products.
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This presentation is enriched with lots of information of gene expression with many pictures so that anyone can understand gene expression easily.
Gene expression is the process by which the information encoded in a gene is used to direct the assembly of a protein molecule.
Gene expression is explored through a study of protein structure and function, transcription and translation, differentiation and stem cells.
It is the process by which information from a gene is used in the synthesis of a functional gene product.
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Regulation of gene expression:
Regulation of gene expression includes a wide range of mechanisms that are used by cells to increase or decrease the production of specific gene products (protein or RNA).
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CLASSIFICATION OF GENE WITH RESPECT TO THEIR EXPRESSION:
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Promises and Challenges of Manufacturing and Testing Viral Producer Cell Lines
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Clinical development of cell-based therapies in the UK A presentation by Chie...
Clinical development of cell-based therapies in the UK A presentation by Chie...Cell and Gene Therapy Catapult
Clinical development of cell-based therapies in the UK
A presentation by Chief Clinical Officer, Natalie Mount 2013Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
GTPs vs. cGMPs
General comparison of the 21CFR 1271 and the 21CFR 211 Regulations for Cell Based Biologics Manufacturing
cGMP Case Study Training
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
25th Annual ROTH Conference
CEO Chris Calhoun presents at the annual ROTH conference on Monday, March 18 in Dana Point, CA
US Pharma presentation on clone screen strategy for monoclonality using Solen...
Presentation by a Cell Metric CLD customer in US about their use of the system in clone screening for cell line development.
This presentation is made available courtesy of Momenta Pharmaceuticals and IBC Conferences
Discovering New Innovations in Oncology
To learn more visit:
https://insidescientific.com/webinar/cutting-edge-conversations-discovering-new-innovations-in-oncology/
Starting off the conversation, Dr. David Bunka will present specific case studies for prostate cancer, multiple myeloma and chronic myelomonocytic leukaemia, highlighting the ability of Optimer technology to deliver novel targeted therapeutics for cancer treatment. Optimer binders are small, highly target specific oligonucleotide-based affinity binders. The Optimer platform offers the ability to develop specific binders targeted to a specific biomarker or to an oncological cell phenotype without the need for known biomarkers. Optimer therapeutics are enabling new strategies in cancer treatment, including the targeted delivery of diverse payloads to cancer cells for precision chemotherapy, or gene therapy approaches.
Dr. Cathie Miller will discuss how archived tissues contain valuable information for clinical research. For over thirty years, BioIVT has worked to expand the characterization of their archived tissues. BioIVT offers complete NGS project management that ensures success. In this presentation, Dr. Miller will review BioIVT’s comprehensive process, their strengths in sample collection through library prep, their in-house and validated partnership capabilities and how BioIVT elevates science.
Finally, Henry Sebesta will introduce KromaTiD’s proprietary technology, Directional Genomic Hybridization™, as an analytical solution for gene & cell therapy oncology treatments. Specifically, Mr. Sebesta will be addressing what Directional Genomic Hybridization is, how it works, and how it can be used to monitor highly important clinical safety metrics including therapeutic vector integration, and genome wide structural rearrangement events.
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Cell Therapy Manufacturing: Regulations and Facilities
- 1. Cell Therapy Manufacturing: Regulations and Facilities William R. Tolbert, Ph.D. BIOCOM Meeting – August 11, 2005
- 5. 21 CFR Part 1271
- 6. Regulatory Requirements for HCT/P’s
- 13. WRT&A
- 14. WRT&A
- 15. WRT&A
- 16. WRT&A
- 18. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com