I sat down with Sadik Kassim, Chief Technical Officer at Vor Biopharma to discuss the benefits of CRISPR-engineered stem cell therapies, the challenges and feasible solutions, what’s next, and more.
- Good Documentation Practices And Data Integrity: The Conjoined Twins Of Compliance And Good Business Practices
- Cell Therapy And A New Approach To Allogeneic Hematopoietic Stem Cell Transplant
- The Future Of Regenerative Medicine: A Macro View On Emerging Applications
- Charting A Course Into The Unknown: Manufacturer Considerations In Gene Therapy
- Scaling Cell and Gene Therapy Manufacturing Operations
- ASGCT On The COVID-19 Vaccine
- The Rise Of Gene & Cell Therapy And The Resulting Need For In-House Production Facilities: A Guide
- Operationalizing Cell & Gene Therapy: Challenges And Solutions
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
When Other CROs Said No, We Said Yes — To The Nearly Impossible
The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.
Adenovirus Production In Single-Use Bioreactor System
Rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using such a system.
Understanding And Controlling Raw Material Variation In Cell Culture Media
An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
Robust Field Guide To qPCR
qPCR remains the gold standard for validation of microarray and next generation sequencing data and the method of choice for both clinical and basic research labs for a wide range of applications. However, there remains general concern about the production of data that truly reflects the tested experimental conditions. We have developed a comprehensive guide to performing the ultimate qPCR experiment. The following is a snapshot of the critical steps needed to achieve excellent results.
Virus Reduction Of An Affinity Capture Step: Viral Clearance For Protein A
Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
Quantitating Binding Similarities In IgG Fcγ Receptor Analysis
Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.
Effectively Securing Cell And Gene Therapies With Closed Systems
Single-use connectors offer an easy-to-use method for flow path sterility and integrity during cell and gene therapy manufacturing. It also enables the protection needed to avoid costly failures from contamination.
Minimizing Errors And Saving Time In Drug Receipt Processes
The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system.
CAR-T Cell Lentiviral Transduction By Spinoculation
There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. Learn how to streamline this step while keeping flexibility during process development.
Benefits And Challenges Of Driving Modernization In Vaccine Development
Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.
CELL AND GENE LIVE
CRISPR-engineered stem cell research has made tremendous advancements in the past five years, but challenges still exist. To overcome those challenges, industry experts, such as Sadik Kassim, CTO at Vor Biopharma, have dedicated their careers to the scale and manufacturing of CRISPR-engineered therapies.
Check out our discussion with Sadik on the benefits, the challenges and feasible solutions, what’s next, and more.Cell & Gene Live On-Demand
CELL AND GENE CONTENT COLLECTIONS
Ensuring scalability and efficient timelines in manufacturing while maintaining a reasonable cost is a major component of the cell and gene therapy sector in and of itself. Can the product be manufactured in the quantity and of the quality necessary to meet demand? Are your development protocols and timelines in order? Have you chosen the right facility, and have you invested in the best possible technology and equipment to ensure scalability? These are just some of the questions we answer for you in our collection of original editorial that caters to cell and gene therapy manufacturing processes.More Content Collections