INSIGHTS ON CELL & GENE MANUFACTURING
Large Scale AAV For Preclinical Gene Therapy Studies
Good laboratory practices (GLP) grade vector has the quality required for nonhuman primate studies and is a cost-effective option, because it avoids the infrastructure costs of good manufacturing practices (GMP) facilities. And the lead time to get GLP-grade vector could be much shorter. UMMS and Cytiva have collaborated to manufacture GLP grade viral vector giving you access to industry-leading development platforms and processing equipment plus professional and scientifically knowledgeable staff to help you get your research to the clinic faster.
Evaluating Current Manufacturing Platforms For Recombinant AAV Production
Realizing the full potential of viral vector-based therapies requires an understanding of the platforms currently available for recombinant AAV production as well as how to properly evaluate them.
How To Prepare For Future Viral Vector Manufacturing Technologies And Platforms
The challenges and shortage of vector production reflect the fact that these materials and products are having such strong clinical success. Let’s celebrate the reason for this demand. To meet it, we need to industrialize and rethink how we transition from what has historically been carried out in translational clinical centers at smaller scale, using flasks and open systems, towards commercial production and methodologies.
How To Calculate Viral Vector Yields: A Critical Component Of The “Make vs Buy” Analysis
Calculating viral vector yields is essential to determine how much drug product is needed for a specific gene therapy. This calculation will determine either how much internal manufacturing capacity is needed or how much it may cost to manufacture at an external contract development and manufacturing company (CDMO).
Andelyn Biosciences - Manufacturing Life-Saving Gene Therapies
Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.
Optimizing Cell Activation, Cytokine Stimulation, And Bioreactor Systems For Efficient Ex Vivo Expansion Of Human T Cells
In this study, we investigate the compatibility and efficiency of ex vivo T cell expansion from human peripheral blood mononuclear cells (PBMCs) using the novel Cloudz™ CD3/CD28 dissolvable polymer microparticles in combination with the G-Rex® bioreactor system and varying dose schedules of IL-2. Additionally, cells were cultured in serum-free media conditions after determining the best seeding density, and cytokine dosing schedule.
Foundations Of Immuno-Oncology: Advancing Basic Science & Translational Research
In this eBook, we investigate immunotherapeutic approaches that are at the forefront of the field for targeting solid tumor types and their associated challenges. Within each interactive chapter, you’ll also learn more about our diverse portfolio of solutions and capabilities that range from trusted gold standard reagents and kits to innovative technologies that are helping researchers advance their discoveries to the clinic.
An Audacious Gene Therapy Program Creates A New CDMO Leader
The road to the formation of Andelyn Biosciences started more than 15 years ago on the third floor of a research building at Nationwide Children’s Hospital in Columbus, Ohio. At that time, GMP facilities were unheard of at children’s hospitals and gene therapy research was a rarity.
Andelyn Bioscience Solutions
Looking for scalability in clinical manufacturing? Andelyn Bioscience’s current Good Manufacturing Practices (cGMP) Clinical Manufacturing Facility operates according to FDA cGMP Guidelines and with multinational health agencies around the world.
Biosafety In Gene Therapy: Applying The Latest Regulatory Guidance For RCL Testing
The use of lentivirus vectors to produce groundbreaking gene therapies is on the rise. Ensuring the biosafety and quality of these vectors is achieved through a multi-tiered testing approach. For lentivirus-based therapies, generation of replication competent particles is a potential risk. While improvements in design and manufacturing have decreased the probability of producing replication competent viruses, regulatory agencies provide guidelines to test for their presence at multiple stages in production.