Quality Systems

Excellence in Quality Systems

ProtaGene’s experience and dedication to quality systems through our assay protocols and data management processes enable us to confidently navigate our clients’ needs throughout the regulatory journey. Quality Systems are key to the experience and value we provide clients and are a mainstay of our corporate culture.

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Quality is Engineered into Our Organization

We have consistently implemented and applied a successful quality management system that has been audited by both lead pharmaceutical partners and regulatory authorities. ProtaGene’s experienced team offers a wide range of support, including analytical method development, method validation, method transfer, stability testing, release testing for biopharmaceutical products, and highly sensitive data analyses platforms for applications such as integration site analysis.

Good Manufacturing Practice (GMP)

Our Dortmund and Heilbronn sites are regularly inspected by the local authorities in Arnsberg and Tübingen, respectively. The GMP certification was first issued in 2006 for GMP lot release testing of commercial protein products and continues to be GMP certified due to its rigorous quality management system that oversees all processes and meets the requirements of the EU and FDA GMP guidelines.

Coming soon: GMP to our Burlington, MA site.

Good Clinical Practices (GCPs)
Good Clinical Laboratory Practice (GCLP)
Good Laboratory Practices (GLPs)

For both Heidelberg and Boston sites, the quality management systems are GCP, GCLP, or GLP compliant as appropriate and oversees all processes related to clinical and non-clinical studies. In 2021, our site in Heidelberg obtained ISO 9001:2015 certification from TÜV Rheinland with the scope of service and consultancy for research, development, and implementation of innovative therapies, medical and biotechnological procedures such as integration site analysis.

Quality Management Systems

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    Precise protocol-driven systems and procedures

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    Traceable data and documentation

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    Document control

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    Intensive training programs

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    Comprehensive inspection/auditing programs both internally and externally

System for qualification of equipment, particularly computerized systems based on Good Automated Manufacturing Practice (GAMP)

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    Qualification of Subcontractors and Service Providers

Complete Data Integrity

Excellence in data integrity is critical to meeting clients’ needs and adhering to GMP, GCP, and GCLP guidelines. To ensure data integrity, we have implemented a multi-layered approach:

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    LIMS-driven processes for CMC and sample analysis

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    Proper handling of user rights

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    Robust cybersecurity programs

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    The appointment of system administrators

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    Adhering to FDA 21 CFR Part 11 audit trail requirements

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    Thorough training of all team members

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