ProtaGene

www.ProtaGene.com

Inselwiesenstrasse 10
Heilbronn
74076
Germany

+49 7131 74 50 40

Summary

ProtaGene is a world-leading CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and complete protein and gene analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021, GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were added to our portfolio, establishing ProtaGene. The organization operates four sites in Europe and North America and works in advanced therapeutic platforms with leading biopharmaceutical and gene therapy companies worldwide.

Profile

ProtaGene is a Unification of Expertise in Protein, Gene and Cell Therapy Analytics

Innovative Analytical Solutions Enabling the Development of Biologics, Gene and Cell Therapy Products

Advanced therapeutic discoveries, technologies, and novel approaches emerge daily, and analytical expertise is the backbone required to achieve commercial success. The market needed a new kind of analytical solutions partner. In 2021, Protagen Protein Services, BioAnalytix, and GeneWerk joined forces to establish ProtaGene, an analytical solutions partner that combines their collective experience of nearly thirty years. ProtaGene leverages our team's diverse advanced biologics and cell and gene therapy development expertise to meet the market's current and future challenges—comprehensive solutions, technical platforms, and quality processes allowing pharma and biotech companies to accelerate regulatory approval of medicines to treat patients in need.

ProtaGene provides analytical solutions to progress the development of biologics and cell and gene therapeutics. From research to commercial product release, we provide the most advanced, integrated, and complete analytical solutions and expert consultation to support our global clients' decision-making throughout the development process.

Solutions for Biologic Development

Expertise in advanced method development, early to late-stage characterization, GMP product testing, and full analytical packages for
product lifecycle management, including:

• Phase Appropriate Product Characterization Pre-IND through BLA
• Manufacturing and Process Analytic Testing
• ICH/GMP QC Lot Release and Stability
• Biosimilar Program Support from Clone Selection through Commercial Release
• Clinical/In Vivo Sample Analytics for Quantitation and Attribute Monitoring

Solutions for Cell & Gene Therapy Development

ProtaGene has been at the forefront of developing DNA/RNA and protein analytics that advance gene therapy safety.

CMC & Product Development

• Enabling Process Development Solutions
• Complex Vector Characterization, CQAs & Correlations
• Custom Process Residuals & Impurity Methods
• Genome & Gene Editing Analysis
• Gene Expression Quantitation
• Safety Assessments by Integration Site Analysis Bioanalysis Support
• Biodistribution
• Vector Shedding