Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.
Feature|Events|October 1, 2026
- BioPharm International September October 2026
- Volume 39
- Issue 5
Personalizing Dendritic Cell Vaccines to Prevent Cancer Recurrence
Author(s)Keith L. Knutson, Feliza Mirasol
Keith Knutson, PhD, of Mayo Clinic explains why vaccine manufacturing speed and cost will determine real-world scalability.
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Keith L. Knutson, PhD, of Mayo Clinic discusses how personalized dendritic cell vaccines target tumor heterogeneity, build lasting immune memory, and overcome tumor-driven immune suppression. He outlines why manufacturing speed and cost will shape adoption and why pairing vaccines with checkpoint inhibitors offers the most promising path toward durable cancer control.
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Matt Trupo, Richard Jaenisch, and Brian Drapeau explore how AI advances biological insights, drug-target discovery, and supply chains.
Aldevron and IDT added PE Ultra prime editor mRNA and 6 ABE8e base editor mRNAs to help researchers edit DNA without double-strand breaks.
Shilpa CDMO's $50 million plan adds 10 kL of SPPS reactor capacity in Raichur, India, with its first commercial peptide line opening in December 2026.
CAR-T transformed blood cancer care, but solid and brain tumors demand different delivery, manufacturing, and safety strategies to work.
Inovio reports that Voceryq spared 27% of adults with recurrent respiratory papillomatosis from surgery for 12 months in a 26-patient efficacy group.
Lonza's Visp expansion adds 3 multiproduct suites at up to 1200 L plus 500-L single-use capacity to scale commercial ADC production from 2028.
The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.
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