Peptides CDMO · Hytanbio Tech
CDMO Process
Eight project gates from brief and feasibility through scale-up, documentation and supply.
An eight-gate peptide CDMO process
- Project brief. Confirm sequence or identity, application, scale, destination and business objective.
- Feasibility review. Assess technical fit, risk, analytical needs, materials and missing inputs.
- Process development. Define route, conditions, purification approach and impurity-control strategy.
- Pilot production. Generate representative material and learn how the process behaves at a larger scale.
- Analytical QC. Apply agreed methods and compare results with written acceptance criteria.
- Scale-up manufacturing. Plan equipment, materials, controls, scheduling and batch execution.
- Documentation and release. Review available records and batch-specific documents before release.
- After-sales support. Coordinate repeat orders, deviations, packaging, logistics and supply planning.
Confidentiality and change control
Project information is handled for quotation and execution purposes. NDA requirements can be discussed before detailed sequence, method or customer-specific documentation is exchanged. Material, method, specification and packaging changes should be reviewed before execution.