Cellipont and Xiogenix Validate Automated Fill-Finish for Cell Therapy Scale-Up
- Collaborative white paper demonstrates Xiogenix ARES X20+ platform maintains formulation accuracy (98.2%–103.6%) across 17-fold process scale increase in cell therapy manufacturing.
- Automated platform preserved cell viability post-formulation and addressed downstream variability; enhancements implemented include priming, pressure monitoring, and gravimetric control.
Operational Impact
Cellipont's published validation of automated fill-finish scalability may reduce perceived risk for CDMO buyers evaluating cell therapy manufacturing capacity and process consistency as programs transition to larger clinical trials.
Source: PharmaSource RSS
CordenPharma Expands Italy Injectable Capacity to 500M Units/Year
- CordenPharma acquired 11,000 m² building and 26,000 m² land adjacent to its Caponago (Milan) site in July 2026, expanding footprint by >50% as part of €80M multi-year injectable CAPEX program.
- Two new aseptic fill & finish isolator lines—Bausch & Ströbel combo line and Syntegon high-speed PFS/cartridge line (>500K units/day)—targeted for completion mid-2027 and 2028, combined with doubled analytical capacity.
- Expanded facility will accommodate minimum four aseptic fill & finish lines, four visual inspection lines, and four packaging lines, supporting PFS, vials, cartridges, lyophilized formats, and auto-injectors across peptides, LNPs, small molecules, biologics, and oligonucleotides.
Operational Impact
CordenPharma's Caponago expansion adds 500M units/year of aseptic fill & finish capacity for peptides, LNPs, and biologics, with integrated LNP manufacturing on-site and completion phased through 2028, materially increasing European injectable CDMO availability for commercial-stage programs.
Source: Contract Pharma Breaking News RSS
EpilepsyGTx Selects Viralgen for EPY201 AAV Gene Therapy Manufacturing
- EpilepsyGTx partners with Viralgen to manufacture EPY201, an investigational AAV gene therapy for focal refractory epilepsy, ahead of first-in-human trials.
- Viralgen will deploy its Aava platform, which has produced 1,500 AAV batches and supports scalable manufacturing across AAV serotypes from early development through commercial scale.
Operational Impact
Viralgen's selection for EPY201 manufacturing demonstrates continued demand for its Aava platform in advancing AAV programs from IND-enabling studies into clinical development, reinforcing its position in early-stage gene therapy CDMO capacity.
Source: PharmaSource RSS