Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
- Europe's ATMP Opportunity Still Requires Local Navigation
- The Unspoken Truth About Cell Therapy Product Understanding
- Overcoming Recovery Challenges In AAV Production
- In Vivo CAR T Needs More Than Better Cell Engineering
- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- Implementing And Optimizing Your eQMS
- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
- Choosing Analytical Technologies At The Right Stage Of Development
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
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Assessing Viability And Real-Time Apoptosis/Necrosis
Malignant gliomas are aggressive brain tumors that resist standard treatments. Discover why researchers focus on real-time cell death dynamics to develop targeted therapies and promising strategies.
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Peptide Mapping Of Adeno Associated Virus Capsid Proteins
Peptide mapping helps reveal AAV capsid protein identity, sequence coverage, and potential modification patterns, giving gene therapy teams a clearer view of viral protein quality across workflows.
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Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation System
Learn how closed-system automation, combined with expert technical guidance and protocol optimization, turned a persistent manufacturing bottleneck into a reliable, scalable process.
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The Value Of Human Panel Testing Downstream Of Donor Screening In The Allogeneic Therapy Pipeline
Allogeneic cell-based therapies require rigorous donor screening for adventitious viruses. qPCR-based assays enhance detection accuracy, sensitivity, and specificity, supplementing serological testing to ensure safer drug development and production.
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Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up
Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.
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High-Throughput 90-Minute ELISA
Discover how one solution can be utilized to measure Human IgG and human IFN gamma, which are key targets in pharmacokinetic studies and immunotherapeutic drug safety testing, in just 90 minutes.
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Electroporation Enables The Efficient, Scalable Packaging Of CRISPR-Cas9 RNPs In Virus-Like Particles
Discover how electroporation technology enables efficient, scalable production of CRISPR-Cas9 VLPs with high editing activity in both adherent and suspension HEK293 cells.
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Fast And Scalable Fc Quantitation In Supernatants
In biopharmaceutical development, the Fc PAIA Titer assay offers a fast, cost-effective, and automatable solution for high-throughput Fc quantification to enhance efficiency, support research, and accelerate production advancements.
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Enhancing AAV Production Performance And Economics
Enzymatically produced dbDNA offers safer, faster, and more scalable AAV manufacturing by reducing costs, improving full capsid yields, and enabling high‑fidelity, bacteria‑free DNA production.
NEWSLETTER ARCHIVE
- 08.31.26 -- Next-Gen Cell & Gene Manufacturing Solutions
- 08.31.26 -- Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- 08.29.26 -- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- 08.28.26 -- OPCU: Scaling Your Program Without Creating New CDMO Risks
- 08.28.26 -- What Goes Into Restarting A Shelved Orphan Drug Candidate?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- Solving Vector Yield Challenges Starts Long Before Manufacturing
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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