Cell and Gene Regulatory

31. Improving AAV Manufacturing: Advancements In Full Capsid Enrichment 8/19/2026

    As AAV manufacturing matures, integrated optimization of capture, buffer chemistry, load conditioning, and AEX polishing enables scalable full capsid enrichment, improving product quality and manufacturability.

32. Chromatography Equipment Maintenance In An Era Of Acceleration 8/19/2026

    As chromatography systems become more sophisticated, maintenance directly influences uptime. Learn why coordinated maintenance strategies are essential for supporting complex analytical work.

33. Unlocking The Future Of Cell And Gene Therapies 8/19/2026

    We took the opportunity to speak with some BioPhorum members about issues such as emerging technologies, regulatory challenges, and engagement with regulators in the advanced therapy medicinal products (ATMP) space.

34. What Goes Into Restarting A Shelved Orphan Drug Candidate? 8/19/2026

    The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

35. Beyond Sensitivity: Building A Robust Multi-Matrix AAV Shedding Assays 8/17/2026

    AAV gene therapy shedding studies demand matrix-specific extraction, not a one-size-fits-all approach. See how validated multi-matrix assays achieve 99-100% accuracy across blood, saliva, semen, serum, and urine.

36. Beyond Sensitivity: Lessons From Developing A Robust Multi-Matrix qPCR Assay For AAV Vector Shedding 8/17/2026

    AAV gene therapy shedding assays demand matrix-specific extraction and rigorous validation across blood, semen, urine, and saliva. Learn the strategies that ensure reliable qPCR data across biological matrices.

37. Flow Cytometry Clinical Development Testing 8/17/2026

    Eurofins Clinical Trial Solutions delivers end-to-end flow cytometry testing across oncology, immunology, and cell and gene therapy programs, backed by 20+ years of expertise and a globally harmonized lab network.

38. Navigating An Uncertain Regulatory Environment For mRNA-Based Products 8/17/2026

    mRNA developers face a regulatory gap: as of 2024, neither FDA nor EMA has issued CMC-specific guidelines. Learn how early regulator engagement and CDMO partnerships reduce risk.

39. Strengthening cIEF Method Validation With cIEF-MS 8/14/2026

    Preparing for method validation, a biopharma company needed to characterize cIEF charge variants and confirm peak identities for regulatory readiness.

40. What Recent FDA CRLs Reveal About CMC 8/14/2026

    FDA-released CRLs reveal common reasons drug applications miss approval. Many point to recurring CMC issues that can be identified and addressed earlier in development.