Design and modeling from cell banking to harvest, including cell line selection, media optimization, bioreactor design, and critical parameter definition to ensure consistency and yield.

Chromatography skid design, resin selection, column sizing, buffer formulation, and purification optimization to improve recovery, throughput, and quality.

Support for drug product formulation, lyophilization cycle design, isolator integration, and pump-based/time-pressure filling systems for both sterile and non-sterile applications.

Guidance for seamless transitions from lab to pilot to commercial manufacturing, including documentation, validation support, and training.

Use of computational and empirical models to simulate process behavior, identify critical control points, and reduce scale-up risk.

Ongoing technical guidance and process improvement for both drug substances and drug products, across clinical and commercial programs.