OPUS® GMP Manufacturing Process
For large-scale GMP manufacturing, OPUS® 2.5 - 80R Columns are packed in ISO 7 cleanrooms under a best in class ISO 9001 quality system.
Manufactured in ISO class 7 clean rooms
OPUS 2.5 - 80R Columns are packed in controlled classified clean rooms which meet ISO Class 7 non-viable particulate (NVP) standards. Buffer preparation occurs in a room which meets ISO Class 8 NVP standards.
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
- Monitored weekly for viable and non-viable particles
- Monitored for viable contaminants during packing operations while dosing chromatography resin into the columns
- Restricted access area dedicated to the production of OPUS® columns only
- Routine cleaning and disinfection schedule
- Monitored room pressure differentials, 100% HEPA filtered air used to maintain air quality
- Required gowning procedures posted in all relevant areas
Complete regulatory support file
To support customer filings, the OPUS Columns Regulatory Support File contains the following sections:
- Product specifications
- Manufacturing procedures
- Extractables and leachables
- Shipping qualification
- User instructions
- Material certificates
- Example Certificates of Analysis
- Product contact materials
Certificate of analysis for each column configuration
Configuration Options
In order to provide the most flexibility, OPUS Pre-packed Columns are available for non-GMP and GMP applications. In general, OPUS non-GMP and GMP Columns are identical except as noted in the table. Resin samples are not provided with OPUS non-GMP Columns. OPUS GMP Columns come with a resin sample for incoming resin identity testing at the end-user's facility.
| Certificate component | Manufacturing Pre-GMP OPUS 2.5 - 80R |
Manufacturing GMP Run Ready OPUS 2.5 - 80R |
|---|---|---|
| Certificate of Analysis | ♦ | ♦ |
| Catalog number | ♦ | ♦ |
| Lot number | ♦ | ♦ |
| Serial number | ♦ | ♦ |
| Actual column diameter | ♦ | ♦ |
| Actual bed height | ♦ | ♦ |
| Resin type | ♦ | ♦ |
| Resin lot number | ♦ | ♦ |
| Shipping/Storage buffer | ♦ | ♦ |
| Packing date | ♦ | ♦ |
| Asymmetry result | ♦ | ♦ |
| Theoretical plate count (N/m) result | ♦ | ♦ |
| TSO 9001 Compliance Statement | ♦ | ♦ |
| Product Contact Materials Compliance Statement (animal-free, EMEA 410/01, USP Class VI) |
♦ | ♦ |
| Copy of Resin Certificate of Analysis | ♦ | ♦ |
| Packing environment | ♦ | ♦ |
| QC chromatogram | ♦ | ♦ |
| Chromatography resin control statement | ♦ | |
| Resin sample for QC analysis | ♦ | |
| Endotoxin test result <0.25 Eu/ml (pass/fail) | ♦ | |
| Bioburden test result <10 CFU/ml (pass/fail) | ♦ |
Manufacturing Centers of Excellence
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands, Germany and Estonia.
