Our quality

At nagene, quality and continuous improvement are fundamental to everything we do. Our commitment to excellence is embedded in our processes, standards, and corporate culture. We operate according to the highest ethical principles and are dedicated to meeting and exceeding industry standards.


Quality

Quality Excellence

Quality



nagene maintains an ISO 9001 certified Quality Management System compliant with EU GMP principles as defined in EudraLex Volume 4.

Our corporate quality policy applies to all functions and includes the following core principles:

  • Continuous improvement of our Quality Management System to exceed customer and regulatory expectations
  • Decision making based on Quality Risk Management
  • Strict confidentiality and protection of customer data

Central to our operation is our integrated Quality Management System, which holistically considers all processes within the company and allows them to harmonize with each other.

Key elements include:

  • Non-Conformance Management including Corrective and Preventive Actions (CAPA)
  • Change Control
  • Training
  • Document Management
  • Internal Audits
  • Data Integrity
  • Supplier Management
  • Quality Risk Management
  • Qualification and Validation

Quality Management System

Laboratory work at Nagene

Through the seamless integration of our QMS into daily operations, nagene sets a gold standard for quality in the genetic materials market.

How does this affect your product?

At nagene, remember that you benefit from comprehensive quality oversight, from project initiation to final product release. Our experienced quality team is always available to address questions or specific requirements.

We also welcome and support external customer audits, providing full transparency into our processes and operations.

For any quality-related inquiries, please contact us at quality@nagene.at

Quality Control

Quality control is not a buzzword at nagene, it is embedded into every step of daily operations, from in-process checks to final product release.

01

Sequencing

State-of-the-art sequencing ensures sequence integrity, accuracy and consistency. Final QC includes sequencing of the complete plasmid, not just the insert.

02

Concentration Determination

Concentration is determined using UV/VIS spectroscopy and fluorometric methods. Values can be precisely adjusted to your specific requirements.

03

Purity

To confirm purity and the absence of organic contaminants, we evaluate A230/A260 and A260/A280 ratios for each sample.

04

Endotoxin Testing

We offer endotoxin-free workflows to avoid downstream endotoxin removal. Effectiveness is verified through corresponding testing.

Technology Center Vienna – we are here

Get a glimpse of our location at the Seestadt Technology Center in Vienna. This innovative knowledge park is easily accessible by both car and public transportation.

How to find us

Christine-Touaillon-Straße 11/2.12
1220, Vienna, Austria

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