Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.
- CDER Wants Your Input On Improving Integrated Reviews
- Tune Therapeutics On Clinical Readiness, Technology Adoption
- Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL?
- iPSC-based Gene Therapy: Applications And Challenges
- What's In The Leukopak Matters For Cell Therapy Manufacturing
- The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
- Computer Systems Validation Pitfalls, Part 1: Methodology Violations
- How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Screening Peptones, Including "Titration And Blending" Protocol Examples
Dive into the importance of peptone selection, instructions for reconstituting peptone powders for mammalian cell culture, and discover starter packs containing commonly used peptones for specific applications.
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Perspectives On The Adoption Of Fully Closed Processing
In this study, industry experts share their perspectives and plans related to the implementation of fully closed processing. Explore the drivers and challenges of fully closed processing and more.
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Get Full Control Of Your T Cell Isolation
This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.
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Bringing Clinical Testing To New Heights In New Jersey
Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.
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Modeling The Economics Of Vaccine Manufacturing
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Chromatography Solutions For AAV Full And Empty Capsid Separation
Effective separation of full and empty AAV capsids requires implementation of purification strategies that differ from standard approaches used for traditional modalities. Explore two cases describing such approaches.
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Biotech Files NDA Following Risk-Based Mock Inspection
See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.
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Improving Patient Health And Safety: Medical Safety Scientist
See how this experienced safety scientist managed benefit-risk assessments and pharmacovigilance while streamlining product development and lifecycle management for a pharmaceutical company.
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Highly Efficient Production Of Adeno-Associated Virus
This study evaluates the performance of a flexible, automated fixed bed reactor (FBR) system during AAV production, comparing it with a similar FBR system and 2D cell culture controls.
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Isolation Of TILs Improves The Sensitivity Of Single-Cell Immune Profiling
Look further into the study of a new workflow for the isolation and analysis of tumor-infiltrating lymphocytes to see how it could become a valuable tool for immunotherapy researchers.
NEWSLETTER ARCHIVE
- 10.22.24 -- The Latest Strategies For Quantifying AAV Capsid Titer
- 10.21.24 -- Accelerate Bioprocessing In Gene Therapy Using Octet Biolayer Interferometry
- 10.21.24 -- Comparing In-House Vs. Outsourced Manufacturing Strategies For CGTs
- 10.18.24 -- Cell & Gene Therapy Regulatory And Compliance Solutions
- 10.18.24 -- Transform Clinical Data Review and Medical Review
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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