Novel fields, such as cell and gene therapy require large amounts of cells to be produced and are therefore dependent on efficient scale‐up, the process of increasing bioprocess dimensions. However, as multiple parameters are influenced during this process, it is not easy to keep yields consistent between small‐ and large‐scale approaches. Therefore, in order to design the scale‐up process as efficient as possible, different strategies focusing on different parameters were established over time. In this ebook, Eppendorf thought leaders will give an overview of the current gold standards in scale‐up and share their opinions on advantages and disadvantages of different strategies. Furthermore, scale‐up of both bacterial and mammalian cell culture is experimentally demonstrated in this publication.
BioNTech and Bristol Myers Squibb will replace chemotherapy with Gilead’s TROP2-directed ADC sacituzumab govitecan in the Phase 3 ROSETTA Breast-01 trial of PD-L1×VEGF-A bispecific pumitamig in PD-L1-low or -negative TNBC.
Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
Sanofi breaks ground on an EU-backed insulin API plant in Frankfurt, Summit and ECOG-ACRIN launch a phase 2/3 trial of ivonescimab in first-line biliary tract cancer, and TaiMed’s anti-CD4 antibody TMB-365 lowers HIV viral load in phase 1.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.
At PharmSci 360, Insilica CEO Thomas Luechtefeld will present on auditable agentic AI systems and how they are expanding computational toxicology beyond single predictive models.
Phase 1 data presented at IDWeek 2026 show TaiMed Biologics’ host-directed antibody TMB-365 lowered HIV-1 RNA without resistance, as the company advances an antibody-only maintenance regimen with TMB-380.