Q: Which GMP regulations do you follow?
A: We strictly comply with Chinese GMPs, US cGMPs, and EU GMP.
Q: Do you accept the customer’s quality audit onsite?
A: Portonbio welcomes customers to conduct on-site audits and provide suggestions for improvement.
Q: Can you produce the plasmids and CAR-T cells and provide related information required for IND filing?
A: The plasmids and CAR-T cells we produce strictly follow GMP standards in perspective of workshop design, production, QA and QC and application dossier. Thus the products can be used for clinical research and IND filing.
Q: Can you cooperate with us to conduct on-site review of new drug declaration?
A: We will fully cooperate with relevant departments to audit production plant, quality system, production records, process development records, etc., and assist customers with IND application and new drug Approval.
Q: Can you store the cell bank (MCB and WCB) for us?
Q: What are the advantages of plasmid and CAR-T process in Protonbio?
A: Our plasmid and CAR-T is produced in a full-closed system with single-use technology to strictly prevent cross-contamination; the expandable modular design makes the use of production space and let it more flexible and efficient, with excellent scalable capabilities; ensuring final products are reliable and compliant.
Q: How do you protect customers' intellectual property?
A: Portonbio has established a comprehensive and rigorous intellectual property protection mechanism to protect customers intellectual property from infringement. We ensure the security of customer information, product information, and intellectual property both in software and hardware.