Quality At Scale

Scaling a biologic from early development to commercial manufacturing without compromising product quality is one of the most consequential challenges your team will face. Every tech-transfer decision, process parameter, and regulatory filing carries risk, and a single misstep can set your program back by months or cost you a batch you cannot afford to lose.

With more than 886 biologics batches produced and 12 commercial molecules manufactured between 2019 and 2024, the scale of experience behind this capabilities overview is substantial. Across four networked sites in the US, Australia, the Netherlands, and Switzerland, teams bring end-to-end coverage from AI/ML-assisted cell line development and upstream process intensification to downstream purification, analytical method establishment, process characterization, and CGMP clinical and commercial manufacturing at batch sizes up to 10,000 L.

You will learn how a stage-gated technical transfer approach, supported by experienced MSAT professionals, protects your critical quality attributes across sites and scales. A featured Fc-fusion case study demonstrates how structured Ambr screening, bridging studies, and robustness assessments delivered a commercialization-ready process across 12 L, 250 L, and 2,000 L batches, hitting titer and timeline targets without CQA deviation. For programs targeting IND as quickly as possible, the Path to IND platform can take your molecule from DNA sequence to clinical packaged drug product in as few as nine months.

Download now to assess how this global biologics network maps to your development stage and commercialization timeline.