Mirus Bio GMP Product Quality Standards
ISO 13485 Certified
Mirus Bio develops and supplies ancillary materials ready for use in RUO and GMP compliant manufacturing processes for cell and gene therapies.
The Mirus Bio QMS is ISO 13485 certified for technology transfer and distribution of GMP grade ancillary materials.
Mirus Bio has developed and implemented a robust and customer centric Quality Management System (QMS) which reflects our commitment to meeting the needs of cell and gene therapy customers as a trusted partner. The following guidance documents were used to establish the Mirus Bio QMS.
- ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes
- ISO 20399:2022, as ancillary materials present during the production of cellular therapeutic products
- USP<1043>, with respect to Tier 2 ancillary materials for cell, gene and tissue-engineered product
Mirus Bio defines GMP Products as ancillary material products distributed by Mirus Bio that are labeled as “For Research Use and Further Manufacturing, Not for Administration into Humans” which may be used in clinical or commercial product manufacturing. These products are manufactured in ISO 13485 facilities and undergo more rigorous testing which align with the ancillary material guidance ISO 20399 and USP <1043>.
We’re committed to providing the highest quality research (RUO) and commercial (cGMP) products for research and cell and gene therapy applications.
Mirus Bio Regulatory, Quality, and Supply Chain Capabilities
“Across our organization, we are intensely focused on achieving the highest standards of quality.
We have to live by a high standard to support
the customer on an ongoing basis so that we never fail the patient.”
Dale Gordon
CEO
Mirus Bio
VirusGEN® GMP Product Quality Standards
- Manufactured in the U.S.A in an ISO 13485 certified facility
- Reagent manufacturing process has been validated to ensure repeatability and robustness
- Final fill-finish is performed in an ISO 5 environment and product is dispensed into sterile bottles
- For each manufacturing lot, Mirus Bio provides a CoA which confirms the product meets the established specifications including appearance, sterility, endotoxin, mycoplasma, and identity for formulation components.
- VirusGEN GMP products are delivered to customer locations around the globe
- To assist with regulatory filings, a VirusGEN GMP regulatory support package is available in addition to documentation and traceability throughout our supply chain to ensure high levels of quality.
- Applicable residual reagent assays are available. Contact techsupport@mirusbio.com for more information.
VirusGEN and related products such as enhancers are not active pharmaceutical ingredients and are not intended to be present in final drug products.
Shipping, Logistics and Supply Chain Security
Mirus Bio’s preferred carrier for our GMP portfolio of products is Marken, a UPS company, who specializes in supporting the biopharma and life sciences industry. Marken uses specialized Pelican Credo shipping containers that are preconditioned to specific temperature ranges and are qualified to stay in range for at least 86 hours. To enable longer transit times, the TIC Panels (proprietary ice packs) are fully replaceable and Marken will replace these TIC Panels at intervals during transit. Marken has many stations worldwide that maintain replacement TICs, enabling global shipments without risk of temperature excursions. In addition, all shipments include a calibrated temperature data logger that provides an additional layer of confidence to our customers.