The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
- The Latest Strategies For Quantifying AAV Capsid Titer
- Sterility Assurance: The Fundamentals
- Comparing In-house Vs. Outsourced Manufacturing Strategies For CGTs
- Expert Voices: Why Aren't QC Labs Fully Automated Yet?
- A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies
- What To Do When Your Regulatory Findings Need Quality Risk Management Action
- New Economics Of Cell And Gene Therapy – Part II
- Keys To Successful CMC Source Document Preparation For Cell & Gene Therapies
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Scientists In Lab Working Together On Digital Tablet GettyImages-893884830]( "The Complete Guide To Immunohistochemistry")
The Complete Guide To ImmunohistochemistryImmunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
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![Scientist Using Bioreactor GettyImages-532549174]( "A Novel Fermenter For High Cell Density Microbial Cultures")
A Novel Fermenter For High Cell Density Microbial CulturesReview the capabilities and robustness of a new single-use fermenter in a fast, exponentially growing, high cell density Escherichia coli (E. coli) process.
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![GettyImages-1089913166-lab-science]( "Generation Of Stable CHO Cell Lines For Protein Production")
Generation Of Stable CHO Cell Lines For Protein ProductionBy following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.
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![Human Immune System GettyImages-1201363459]( "Immune Checkpoint Inhibitors Global Clinical Trials Landscape (2023)")
Immune Checkpoint Inhibitors Global Clinical Trials Landscape (2023)Dive into the forefront of immune checkpoint inhibitors clinical trials with an exploration of the latest trends and key findings.
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![GettyImages-1346675635 Lab Employees]( "Navigating The Biotech Landscape Amidst Covid-19 And Beyond")
Navigating The Biotech Landscape Amidst Covid-19 And BeyondAccess comprehensive insights and analysis for a deeper understanding of the biotech landscape, including optimism and challenges felt throughout 2023 and what the future could hold.
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![GettyImages-1491009758 lab, cell culture]( "Set Your Cell And Gene Therapy Program Up For Success From Day One")
Set Your Cell And Gene Therapy Program Up For Success From Day OnePartner 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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![GettyImages-1404945060-lab-process-cleanroom-research]( "A Mammalian Suspension Technology For Scalable rAAV Production")
A Mammalian Suspension Technology For Scalable rAAV ProductionExplore a HEK293 derived animal component-free suspension cell line as the foundation of an up to 2000-liters scalable and robust platform process that increases the speed of AAV manufacturing.
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![duke-absl-3-facility-singapore]( "ABSL-3 Facility For Duke (National University of Singapore)")
ABSL-3 Facility For Duke (National University of Singapore)Read about a 5-module ABSL-3 facility that was constructed in Singapore, and is used for disease surveillance, research on avian influenza, and other risk group 3 materials.
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![GettyImages-1438509986-isolated-rna-lipid-nanoparticle-LNP]( "The Key To Accelerating RNA-LNP Drug Development")
The Key To Accelerating RNA-LNP Drug DevelopmentLearn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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![GettyImages-954960688 clinical trial team research]( "Pursuing Breakthrough Therapies For Rare Metabolic Diseases")
Pursuing Breakthrough Therapies For Rare Metabolic DiseasesExplore how a comprehensive clinical trial team expertly coordinated the dosing administration and data review for gene therapy, ensuring meticulous management and streamlined processes.
NEWSLETTER ARCHIVE
- 10.11.24 -- How To Accelerate AAV Production And Gene Therapy Success
- 10.11.24 -- New Economics Of Cell And Gene Therapy – Part II
- 10.10.24 -- Ensuring Vial Integrity In The Complex Cell & Gene Therapy Landscape
- 10.10.24 -- Gene Therapy CMC Experts On Late-Stage Process Changes
- 10.09.24 -- Unlocking Scalable Solutions: Reducing Turnover And Enhancing Staffing, Safety
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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