Manufacturing & Quality
Manufacturing Capabilities
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.
Integrated workflow covering expression, purification, formulation, and filling/packaging, supported by standardized SOPs, batch records, and in-process controls for consistent quality.
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
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)
- 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.
- 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.
- 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
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Frequently Asked Questions
Which manufacturing stages can BIORI support?
The manufacturing page describes an integrated workflow covering expression, purification, formulation, and filling or packaging, with flexible batch sizes supporting pilot runs through routine supply.
How does BIORI support lot-to-lot consistency?
The stated controls include standardized SOPs, batch records, in-process checks at critical steps, defined process parameters, release testing, and change-control procedures.
What quality and traceability documentation is available?
The page identifies a QC release panel, batch traceability, an available QA package, SOP-controlled records, and supporting QA documentation available upon request, with an NDA when required.
Can BIORI support scale-up and longer-term supply programs?
The page describes defined scale-up strategies, flexible capacity, capacity planning, safety-stock strategies, and lot-to-lot controls for projects moving from early evaluation to routine supply.
