Manufacturing & Quality
ISO 9001 / ISO 13485 / GMP options
Lot-to-lot consistency & full traceability
QC release panel & QA package available
Manufacturing Capabilities
Scalable Capacity
In-house manufacturing with flexible batch sizes to support pilot runs through routine supply. Capacity planning and safety stock strategies are in place for long-term programs.
Controlled Manufacturing Process
Integrated workflow covering expression, purification, formulation, and filling/packaging, supported by standardized SOPs, batch records, and in-process controls for consistent quality.
Flexible Scale-Up & Supply
Defined scale-up strategies and lot-to-lot consistency controls, including critical process parameters and release testing, to ensure reliable performance from early evaluation to volume production.
Process Control
Defined and documented manufacturing processes with controlled parameters
In-process controls implemented at critical manufacturing steps
Change control procedures applied to ensure process stability
Quality Management
- ISO 13485 & ISO 9001 certified Quality Management System (QMS)
- SOP-controlled operations with document control and training records
- Deviation/CAPA and change control to maintain process stability
- QA documentation available upon request (NDA if required)
Designed and operated with GMP principles for contamination control, consistency, and reliable supply.
- GMP-aligned workflows for raw material production, filling, and release readiness.
- Controlled cleanroom environments where applicable, with defined gowning and material/personnel flow.
- Segregated zones & unidirectional flow to reduce cross-contamination risk.
- Environmental monitoring and validated cleaning practices integrated into routine operations.
- Deviation / change control and CAPA to support continuous improvement.
QC testing across raw materials, in-process controls, and final product release.
- Lot release based on predefined specifications and acceptance criteria.
- Lot-to-lot consistency monitored through trend analysis and reference standards.
- Critical attributes verified (e.g., activity, purity, residual host contaminants where applicable).
- Full documentation package available: CoA, SDS, and traceability records upon request.
End-to-end documentation and traceability across materials, manufacturing, and QC.
- Bullets：Batch records maintained for each production lot, including key process parameters and deviations.
- Material traceability from incoming inspection to finished product, with documented COA/COO where applicable.
- QC records linked to each lot (in-process and final testing), enabling clear release justification.
- Change-controlled documentation updates to ensure consistency across lots and versions.
- Retention samples and record archiving to support investigations and customer audits upon request.
- Audit support with documentation package (CoA, SDS, traceability records, QC summary)
- Change notification and technical documentation support for key materials
- Cross-functional response: Quality + Manufacturing + R&D coordination
- Supply planning for repeat orders and long-term programs
- Clear communication on lead time, lot availability, and shipment conditions
Contact Us
Learn more about our Services or contact us for quality and manufacturing discussions
