Webinars and Presentations
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.
You can view the webinar on the BioInsights website. Run time is 1:01:17.
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.
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.
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.