Pharma/biotech companies are increasingly looking to access large-scale data sets to fill gaps in their computational biology capabilities. Be prepared for the investment.
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?
- Is Your AI Model Trustworthy And Credible In GMP Processes?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Integrated Upstream And Downstream Strategies For Robust Manufacturing
Process robust mAb production requires understanding scale dependent cell environments, leveraging predictive models, and pursuing data driven control to minimize variability and optimize quality.
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Quantitative ROI With DCTs
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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Implementing Medium And High-Volume Drug Handling And Packaging Programs
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
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Control Strategies And Method Development For Nitrosamines In APIs And Drug Products
Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.
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Automated DNA Clean-Up Using Magnetic Bead-Based Methods
Discover how to improve DNA clean‑up through a precise magnetic bead–based workflow, as well as how optimized liquid handling enhances yield, purity, and reproducibility for higher confidence in results.
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AAV Viral Titering Using Nanoplate-Based Digital PCR
Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.
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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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Expanding The Capabilities Of Targeted Integration
See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.
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Seamless Workflow For Environmental Monitoring
Learn how connected sampling tools and compliant monitoring software improve data integrity and streamline compressed gas testing workflows, offering a path to reliable environmental monitoring.
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Alternative Two-Step Mixed-Mode Approach To A mAb Purification Process
Two post–Protein A capture two-step mAb processes were developed and compared to an archetypical three-step mAb purification process using two IEX steps after Protein A capture.
NEWSLETTER ARCHIVE
- 07.02.26 -- New Podcast Episodes: A Midyear Look At Life Sciences, Derisking CNS Drug Development, In Vivo Gene Editing
- 07.02.26 -- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- 07.01.26 -- In Vivo Gene Editing Is Moving From Promise To Proof
- 06.30.26 -- Cell Therapy Without The Cells: Building A Therapeutic Secretome
- 06.30.26 -- Better IDS Workflows Start Here
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
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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