Confused about FDA's draft guidance on potency assays for cell and gene therapy products? Let's clarify a few things and discuss some key considerations.
- CDMO Selection: 7 Steps To Find Your Best Fit
- The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy
- Commissioning & Qualifying: Facility Considerations For Tissue Engineering
- How To Overcome Immune Rejection In iPSC-based Gene Therapy
- Emerging Partnership Trends In Oligo-Based Medicines
- How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery
- Neogene's Focus On Off-The-Shelf TCR Therapies
- Maintaining Harmony With Your CDMO Using 'The Middle Way'
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Simplifying Complex Fluorescence Multiwell Plate Assays
Discover the results and benefits of using the Mica Microhub in fluorescence multiwell plate assays concerning the role of caspase-3 and caspase-7 in the activation of apoptosis.
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Set Your Cell And Gene Therapy Program Up For Success From Day One
Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
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How Can I Increase My Viral Titers And Improve The Percentage Of Full AAVs?
Explore various strategies to enhance viral titer and increase the percentage of full AAV capsids, like modifications to transfection reagents, cell lines, media, procedures, and more.
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Pre-Launch Checklist - A Roadmap To Success
The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.
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Establishing Analytical Methods For mRNA-Based Therapies
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Novel Engineered Plasmids, Optimized HEK293 Cell Line For AAV Productivity
Lonza has further improved its platform process with the creation of engineered plasmids that afford significantly higher titers and productivity levels compared to standard systems.
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Functional TILs From Human Renal Cell Carcinoma
Here, we compare two methods for the dissociation of renal tumor tissue to obtain TILs: a novel, combined mechanical/enzymatic, automated 3-hour process versus an established overnight digestion protocol.
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Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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Agile Use In Non-Software Project
Agile methodology, initially for software development, is now valuable for pharmaceutical and medical device projects, enhancing flexibility, stakeholder satisfaction, and adapting to non-software needs.
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Alofisel P3 Cell Therapy Facility
Despite various issues with a client's CQV project, CAI delivered the project on time and significantly contributed to the delivery of the first ATMP facility in Ireland.
NEWSLETTER ARCHIVE
- 11.12.24 -- Take The Next Step Towards Scaling-Up
- 11.12.24 -- STREAM Edition: What's New In Bioprocess Innovation And Advanced Analytics
- 11.12.24 -- Exploring Sanofi R&D's Batch Monitoring Initiative
- 11.11.24 -- Make It Homogenous With Closed Recirculating Systems
- 11.11.24 -- Imbalance In The CDMO Market And The Long-Term Implications
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
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