08.13.26 -- CDMO Live Europe 2026: Partnerships For An Uncertain World

Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.

Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

Understanding when to leverage GMP vs non-GMP stability studies and where each approach delivers maximum value can help sponsors make better development decisions and reach clinic faster.

Discover examples of visible particle identification and the root cause investigation, along with a discussion of the performance of additional troubleshooting using advanced and innovative technologies.

Annex 1’s updated CCS framework calls for a holistic contamination strategy. Learn how manufacturers can apply it to non-sterile sites and legacy facilities using tailored risk-based approaches.

Controlled nucleation standardizes freezing across all vials, leading to uniform ice crystals and improved lyo cake quality. This critical step reduces variability and supports robust product scale-up.

Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

See an outline antibody-oligonucleotide conjugate manufacturing: process development, scale-up, GMP production, and analytical controls for efficient early-phase clinical material generation

A practical guide to antibody manufacturing — mammalian platforms, downstream efficiency, viral safety, and analytics — plus proven practices to reduce scale‑up risk and ensure consistent GMP supply.

Flexible development and manufacturing are essential for biologics. Explore processes, strategies, and partnership models that move programs efficiently from development to commercialization.

Look at where tech transfer and validation commonly falter, and how disciplined execution helps teams maintain control through PPQ and beyond.

Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.