Quality

Quality Management Systems

Quality policies, manuals, and procedures establish the framework for quality assurance.

Areas of focus

• Risk assessment and mitigation
• Change and deviation management
• Investigations, corrective actions, and training

cGMP Approach

Facility concepts consider applicable cGMP requirements alongside process needs and manufacturing flexibility.

Areas of focus

• Process-flow planning
• Capacity and scale considerations

Analytical Development

Analytical methods support biosimilar quality control and batch release.

Areas of focus

• Protein, impurity, and microbiological testing
• Chromatographic and biological assays
• Method verification and validation

Regulatory Support

Regulatory assistance spans research, scale-up, clinical studies, and launch.

Areas of focus

• Support for manufacturing and marketing submissions
• Domestic and international dossier preparation

Documentation

Development studies inform documentation for drug substance and finished-product dossiers.

Areas of focus

• Manufacturing and control information
• Product characterization
• Quality procedures and manuals

Technology Transfer

Transfer packages connect recombinant cell lines, process development, formulation, and finished products.

Areas of focus

• Technical information across development disciplines
• Careful, systematic transfer
• Continual improvement where needed