What is the difference between cGMP and ISO
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
What is ANAB?
ANAB: (ANSI National Accreditation Board) is a wholly owned
subsidiary of the American National Standards Institute (ANSI), a
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
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.
- 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
- 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,
- 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.