Quality

DNA polymerases - 100% made in Konstanz - ISO 13485 certified

High quality and innovation are in the main focus of myPOLS Biotec.

To ensure full control about our quality standards, all of myPOLS Biotec DNA polymerases and their ready-to-use mixes are produced in-house, in our laboratories in Konstanz. 

We are exclusively using certified suppliers in Germany for components of our products such as ultra-pure dNTPs and buffer reagents.

Additionally, since April 2019, we are certified according to ISO 13485:2016 with the scope: "Development, manufacture and distribution of reagents with polymerase-based systems for use in in-vitro diagnostics". Download the certificate here.

Our quality standards and ISO certification allow us to offer services and products suitable for IVD. Find here more information about IVD services at myPOLS Biotec.

We have a cooperation with the reputable Johner Institute and offer the "DiagnosticGrade" seal for reagents. This unique quality seal ensures performance and compliance of IVD components. All information about DiagnosticGrade

A frequently asked question is about the production scale. Currently, all our productions of DNA polymerases are freely scalable from a few milliliters up to several liters of expression cultures yielding up to milligrams of DNA polymerases. Find here more information about customized & bulk.

Expressed and purified DNA polymerase batches are routinely tested for their purity, activity, and potential contaminations. All myPOLS Biotec products must pass specified quality tests, before they are offered for sale. Hereby we are testing for purity, activity, functionality and for contaminations of each product-lot. 

Should you have further question regarding quality checks, lot-to-lot reproducibilites, customized bulk polymerase amounts, etc.  Contact us!