GeoVax CEO David Dodd sings the praises and is grateful for the program-enabling relationships he has in Europe. At the same time, he harbors lingering disappointment. From the outset of its formation, the biotech has desired to work with U.S.-based CDMOs. But he says he will not give up. “One way or the other,” Dodd says, “GeoVax will have U.S.-based manufacturing.”
- Managing Operational Challenges In CAR-T Clinical Trial Logistics
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- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Building Harmonized Real‑World Data In Oncology
- Where Contamination Control Really Breaks Down In Practice
- Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic
- Trends In FDA FY 2025 Warning Letters
- SUS Interchangeability Assessment And Qualification Best Practices
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Enhanced Flow Kit Performance With Leak And PUPSIT TestingSterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.
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The Art Of PhosphitylationPhosphorylation is key for bioactives, with phosphoramidites favored for high selectivity. Discover how choosing specific protecting groups and new technologies fine-tunes the synthesis process.
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Cleanroom Recovery. Proven Results. Contamination Control Case StudiesThrough this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.
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Assessing Particle Generation In A Single-Use Mixing SystemExplore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.
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AAV Process Intensification Using High Salt Lysis And Salt Tolerant EndonucleaseIn the production of adeno-associated virus (AAV) vectors, cell lysis involves challenges addressed through high salt concentrations and a salt-tolerant endonuclease, enhancing titer and infectivity.
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How To Design And Evaluate Bispecific Antibodies (BsAbs)?Bispecific antibodies combine two antigen-binding sites to enhance efficacy and safety. Their design requires structural strategy, MOA-based evaluation, and rigorous screening for optimal therapeutic performance.
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Preparing For Disease X: Effective Vaccine Development In The Face Of A Future PandemicCDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.
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Overcoming Bispecific Antibody Purification ChallengesEnhance the quality and safety of your BsAb therapeutics with a highly efficient with the right chromatography hydroxyapatite media.
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Large-Scale Exosome Production Stirred-Tank BioreactorsDiscover how engineered exosomes, displaying tumor-homing peptides, offer a promising tool for targeted cytotoxic drug delivery, produced efficiently with a bioreactor for critical research.
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Standardizing Cryopreservation For Cell Therapy Supply ChainsExplore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
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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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