Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Building Sustainable Biopharma Supply Chains Starts With Procurement
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Analytical Approach For Bispecific Antibody Quality Study
Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.
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Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems
Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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How Isogenic Organ-Chips Are Transforming The Future Of Research
Modeling the human brain requires more than simplified systems. New approaches that incorporate diverse cell types are improving how researchers study neurovascular function with greater precision.
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Stability Of Supplemented PRIME-XV T Cell CDM At Room Temperature
Gain insight into how a supplemented medium stored at room temperature for up to 72 hours maintained T cell expansion performance, showing consistent viability and marker expression.
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Superior Performance Of Tubing In Extended Fill-Finish Applications
Tubing durability plays a critical role in extended fill-finish operations, affecting fill counts, contamination risk, operational efficiency, and process reliability.
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CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.
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Correlating NGS Success With Sample Input Quality: A Large Scale Study
DIN values offer a data‑backed way to identify which DNA samples are ready for successful sequencing. With strong correlations to sequencing performance, DIN thresholds help streamline workflows.
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Improved T Cell Expansion Using Closed, Automated Stirred-Tank Bioreactors
A shift from traditional rocking motion systems to stirred-tank bioreactors can enhance T cell expansion, offering greater scalability and more intimate process control.
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Flexible Cell Culture Media For High Titer Production Of AAV In HEK 293
To maximize the results of viral titer and full capsids, it's necessary to undertake systematic process development and optimization of AAV production. The choice of cell culture medium is foundational.
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Automated PUPSIT For Drug Product Applications
Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.
NEWSLETTER ARCHIVE
- 10.10.26 -- Cell & Gene Newsletter - September
- 10.09.26 -- How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
- 10.08.26 -- Streamline Lead Selection & Optimization For Cell Therapy Development
- 10.08.26 -- Risk Managing Through The Void Of ATMP Visible Particle Guidance
- 10.07.26 -- What's Driving The Next Wave Of Genome Editing?
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts
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