Gemini Bio Quality
Gemini Bio’s Quality Management System
Gemini Bioproducts, LLC is a Class I Medical Device manufacturer and supplier of cell culture media, sera, and other reagents manufactured under cGMP guidelines in compliance with 21 CFR Part 820.
Gemini’s Quality Management System has also been certified (download here) to the International Organization for Standardization (ISO) 13485:2016 Quality System requirements applicable to the manufacture and supply of cell culture media, sera, and other reagents.
What that means to you:
| Academic and Research | Startups and Pre-Clinical | For Further Manufacturing | |
|---|---|---|---|
| Reagents | Consistent and reliable products you can count on for research | Consistent products you can use during the transition from bench-research to early clinical trials | Well documented products, risk management and minimization, addressing FDA requirements |
| Custom Media and Buffers | Approved sourcing and manufacturing for cell quality | Stringent procedures, robust documentation, agile manufacturing for custom volume and fill sizes | Stringent procedures, robust documentation, agile manufacturing for custom volume and fill sizes |
Frequently Asked Questions
What is the difference between cGMP and ISO 13485?
cGMP follows FDA guidelines for finished medical devices (21 CFR Part 820) while ISO 13485:2016 is an internationally recognized standard that closely aligns with FDA, EMA and PMDA regulations and is a more comprehensive standard for medical devices.
Why does Gemini follow 21 CFR Part 820?
Gemini’s products are manufactured under cGMP regulations, and because of this, many of them can be used as ancillary materials in clinical settings for gene and cell therapy.
Why did Gemini choose to be ISO 13485 certified?
The ISO 13485:2016 certification process ensures that our quality management system meets internationally agreed upon standards for manufacturing medical devices. The certification gives our customers another level of assurance for our products and our quality/manufacturing system.
What is ANAB?
ANAB: (ANSI National Accreditation Board) is a wholly owned subsidiary of the American National Standards Institute (ANSI), a nonprofit corporation.
ANAB accredited the certifying body that performed the ISO 13485 certification audits for Gemini.
Are you FDA certified?
FDA certification of a biotechnology company does not exist. We follow FDA cGMP practices and many of our products can be used as ancillary material for clinical use.
Are your products clinical grade?
None of our products can be directly injected into a human, but some of our products can be classified as ancillary material. This means that they are suitable to be used in the further manufacturing of products for human use.
What is your cleanroom grade?
Our Cleanroom grade is an ISO 7 background with an ISO 5 filling area.
Do you test your products for COVID-19?
Our products are not tested for COVID-19. We have had COVID-19 measures in place since March 2020. All employees have a daily symptom and temperature check; and if sick, employees are instructed to stay home. Gemini has manufactured viral transport media for FEMA and the state of California, so manufacturing operators had early access to vaccination. Gemini has cleaning and sanitization procedures in place, all products are manufactured with aseptic technique in an ISO 7 clean room with ISO 5 filling area, and many products are 0.1 µm filtered twice.
For human based products, Gemini follows the COVID-19 risk mitigation detailed above.
In addition:
- Our donor centers follow all FDA and EMA guidelines. Donors undergo a physical screening along with a questionnaire, temperature, and COVID-19 symptom check. Donors exhibiting temperatures above 99.5° F or COVID-19 symptoms are not allowed to donate.
- On January 19, 2021, FDA communications state: “Respiratory viruses, in general, are not known to be transmitted by blood transfusion. There have been no reported cases of transfusion-transmitted coronavirus, including SARS-CoV-2, worldwide.” Source.
- Gemini believes that there is a low risk of the COVID-19 virus in the serum supplied to customers. Donors undergo physical and medical screening, COVID-19 is most likely not transmitted through blood, Gemini follows strict COVID-19 protocols for all employees, all products are manufactured in an ISO 7 clean room with an ISO 5 filling area using aseptic technique, and many products are double 0.1 µm filtered.