Cabaletta Bio Adds ElevateBio as Second CDMO Partner Alongside Lonza for Rese-cel
- Cabaletta Bio expanded its CAR T manufacturing network by adding ElevateBio as a CDMO partner alongside Lonza to increase capacity and supply-chain resilience ahead of rese-cel commercialization.
- The company remains on track to report RESET-Myositis registrational data in mid-2027 and plans BLA submission in H2 2027, supported by automated manufacturing partnerships with ElevateBio, Lonza, and Cellares.
Operational Impact
ElevateBio and Lonza now share commercial manufacturing responsibility for a late-stage CAR T program, signaling demand for dual-CDMO capacity in autologous cell therapies and validating automated manufacturing platforms for clinical-to-commercial transition.
Source: PharmaSource RSS
NurExone Selects Made Scientific for Exclusive U.S. Exosome GMP Manufacturing
- NurExone and subsidiary Exo-Top signed binding MOU with Made Scientific for exclusive U.S. GMP manufacturing and aseptic fill-finish of bone marrow-derived exosomes.
- Made Scientific will begin technology transfer immediately, targeting first GMP batches in H1 2027 from its 60,000-sq-ft FDA- and EU GMP Annex 1-compliant Princeton, New Jersey facility.
- Five-year initial term with renewal options; partnership supports NurExone's clinical pipeline and commercial exosome product strategy.
Operational Impact
Made Scientific's Princeton facility gains exclusive exosome manufacturing and fill-finish capacity for NurExone's clinical and commercial pipeline, anchoring utilization through 2027 and beyond.
Source: PharmaSource RSS
Samsung Biologics Achieves 90-Day Dual-Site Tech Transfer for GMP Biologics Manufacturing
- Samsung Biologics demonstrated a parallel, risk-based tech-transfer model delivering first GMP batch at second facility within 90 days by parallelizing gap assessment, analytical readiness, and supply chain qualification from day one.
- Centralized analytical platforms and cookie-cutter facility design across five plants enable single unified process control strategy, eliminating site-to-site method transfer delays and reducing validation studies per site.
- Case studies show comparable cell culture profiles and product titers across 10,000-liter and 15,000-liter bioreactors; Samsung executing five dual-site transfers simultaneously in 2026 with target to improve beyond 90-day timeline.
Operational Impact
Samsung's parallel tech-transfer framework and unified process control strategy across five standardized plants materially reduce timelines and validation costs for sponsors hedging commercial supply risk through dual-site manufacturing.
Source: PharmaSource RSS
References
- PharmaSource RSS — Cabaletta Bio Adds ElevateBio as Second CDMO Partner Alongside Lonza for Rese-cel
- PharmaSource RSS — NurExone Selects Made Scientific for Exclusive U.S. Exosome GMP Manufacturing
- PharmaSource RSS — Samsung Biologics Achieves 90-Day Dual-Site Tech Transfer for GMP Biologics Manufacturing