Webinars and Presentations
The Future of CRISPR Cell Therapies is GMP
The Future of CRISPR Cell Therapies is GMP, hosted by Dr. Jeffrey Buguliskis, the technical editor at Genetic Engineering & Biotechnology News (GEN). Tom Foti, president of Aldevron’s Protein Business Unit, and Dr. Robert Deans, Chief Scientific Officer at Synthego, spoke about their companies’ roles in supporting the project.
Standardization and Large-scale Manufacturing of Plasmids for Viral Vector Production
Success in gene and cell therapy has increased demand for plasmid DNA used to produce viral vectors, both in quantities for commercial products as well as the breadth of different vectors for the expanding number of programs in development.
Data and analysis gathered by Aldevron indicate that standardization and large-scale production of helper plasmids, those that are the same regardless of the specific viral vector produced, represents an opportunity to significantly reduce timeline, cost and risk.
The availability, cost, freedom to operate, and consistency of these plasmids will help address the growing demands of cell and gene therapy. This webinar, done in conjunction with Phacilitate: Exchange, discusses this topic.
James Brown, Ph.D.
Dr. Josh Grieger
Dr. Ryan Cawood
Get more information about Aldevron plasmids
Aldevron webinar library
View past webinars developed by Aldevron experts independently and in conjunction with industry thought leaders.
Webinar: Fibro-Inflammatory Disease Sees Relief in IL-11 mAb Development
In association with Genetic Engineering and Biotechnology News, this webinar focused on development work done by Enleofen Bio in conjunction with Aldevron in monoclonal anti-IL-11 and anti-IL11RA antibodies for the treatment of non-alcoholic steatohepatitis (NASH) and other conditions.
Since IL-11 was recently identified as an essential cytokine for inflammation and fibrosis, Enleofen and Aldevron developed monoclonal anti-IL-11 and anti-IL11RA antibodies for the treatment of non-alcoholic steatohepatitis (NASH) and other conditions. This webinar features:
- Stuart Cook, Ph.D., Professor of Clinical & Molecular Cardiology at the Imperial College of London, and Director and Co-Founder of Enleofen Bio
- Sebastian Schafer, Ph.D., Co-Founder of Enleofen Bio
- Dr. Andreas Weise, Antibody Project Manager for Aldevron
- Run time is 51:10
Webinar: Translating Genome Editing of Stem Cells to the Clinic with Improved Cas9 Specificity
In conjunction with The CRISPR Journal, Aldevron offered this instructive webinar on the CRISPR/Cas9 system. A powerful genome-editing tool that can selectively modify and correct an abnormal DNA sequence inside living cells with single-nucleotide precision, CRISPR is being used to develop groundbreaking treatments for patients without curative therapies.
Although there have been several publications describing engineered Cas9 proteins with diminished off-target effects, we found these examples were also significantly lower in on-target activity, probably due to over-engineering, to the extent that their use for clinical application would be limited. This webinar features:
- Matthew Porteus, MD, Ph.D., Associate Professor, Department of Pediatrics and Institute of Stem Cell Biology and Regenerative Medicine; Stanford University
- Tom Foti, Vice President, Protein Services; Aldevron
Webinar: Overcoming challenges with the supply of plasmid DNA & other raw materials for gene therapy manufacture
Developed in conjunction with BioInsights, this webinar explores plasmid DNA and other critical materials and components for gene and cell therapy manufacturing including specifications, regulatory considerations, timelines and supply agreements. The discussion includes:
- Guidance from our experts on how to best manage supplier partnerships across your supply chain to minimize delays and additional costs throughout development.
- Understanding the potential regulatory impact of changes to raw materials used within your manufacturing processes and how to mitigate risks.
- Real world experiences of sourcing and managing raw materials as your product progresses towards commercial scale manufacture.
Webinar: Cas9 and Cpf1 Gene Editing Tools: Building a path to GMP Cas9
CRISPR–based approaches have become the favored method for gene editing applications. As scientists’ advance their programs from research to clinical trials, they evaluate Cas9 protein from multiple vendors. During this process, questions arise on topics from construct design to quality requirements:
- What methods are used to assess enzyme activity?
- How stable is the protein?
- What QC assays can be used to detect critical contaminants?
In this webinar, Pete Leland and Nicole Kavanaugh provide a technical overview of Aldevron’s Cas9 and Cpf1 nucleases, describing how Aldevron is offering a solution for clients to progress from research grade sample testing to GMP manufacturing. There is also a preview of our GMP Cas9 product, scheduled for release in 2017. The presentation runs 29:18.
Webinar: Epo-R Antibodies: A Paradigm for Antibody-Specificity Testing
This 30-minute presentation summarizes the results of a European consortium to develop and test anti-Epo-R antibodies in different assays that confirm their specificity. Recombinant erythropoietin (Epo) has often been used in the past to treat patients suffering from anemia to improve red blood cell mass. For cancer patients, anemia is a poor prognostic survival factor.
Epo stimulates progenitor erythroblasts to differentiate and proliferate through interaction with its cell receptors, Epo-R which may also be present in cancer cells. This requires highly specific antibodies to be used in order to identify tumors expressing Epo-R which are not currently available commercially. Dr. John Thompson highlights the assays used in this research project as one of the applications of Aldevron’s GENOVAC Antibody Technology.
Contact us if you have any questions about other applications of the GENOVAC Antibody Technology or require details on production of monoclonal or humanized antibodies.
Webinar: Producing Ancillary Reagents for GMP Manufacturing of T-Cell Therapies
In this webinar, Emma Christy of Aldevron explains how the production of raw materials such as plasmids, lentiviruses, and mRNA are an important consideration when manufacturing autologous and allogenic cell therapies. Raw material used in a GMP process must meet both FDA regulations and the requirements of a successful business model. Organizations developing cell therapies must identify optimal raw material strategies to transition to commercialization without compromising quality.
Emma discusses a spectrum of manufacturing and regulatory requirements used to manufacture raw materials and how these choices influence cost and delivery time. In particular, she will share case studies wherein plasmid DNA was produced for subsequent use in an autologous therapy product. We will review the manufacturing technology and process as well as the quality oversight. She also discusses different quality assurance strategies and storage/stability options.
Contact us if you have any questions or would like to connect with an Aldevron expert about your plasmid production project.