When using artificial intelligence in GMP settings, risk management extends far beyond validation. This discussion explores moving AI solutions out of the pilot phase.
- 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
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Cell Culture Automation Of The 3D Cancer Spheroid Assay
Discover how automated 3D cell culture methods enhance efficiency and consistency in high-throughput drug screening to accelerate the discovery of new anti-cancer therapies.
-
How We Used Intelligent Automation to Transform Vendor Selection
Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.
-
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.
-
Maintain Sterility And Ease In CGT Development, Including Cryopreservation
Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.
-
Leveraging Integrated Media Services For Speed And Efficiency
Uncertainty in media stability can limit efficiency and scalability in biologics manufacturing. See how a data-driven approach enables more predictable planning and reduces operational strain.
-
Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility
Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
-
Preventive Control Of Sequencing Through The Insert
Understanding library size distributions helps prevent sequencing through the insert, reducing adapter read‑through. Explore how smear analysis guides optimal read‑length selection to avoid noise.
-
Oligonucleotide Purification And Synthesis
Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.
-
Automation Of 3D Intestinal Organoids Culture
Gain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
-
Navigating The Cell And Gene Regulatory Landscape
Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.
NEWSLETTER ARCHIVE
- 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?
- 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery
- 08.26.26 -- Optimizing Cold Chain & Cryo Logistics
- 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.
More Content Collections