The development and production of biopharmaceuticals is a rapidly evolving business that requires up-to-date knowledge, expierence and analytical excellence.
Protagen Protein Services - Quality from Clone to Clinic
Protagen Protein Services (PPS) and BioAnalytix, a Protagen Protein Service company, is a leading global analytic CRO and recognized expert for analytical services in protein science. The company is a best-in-class partner for the biopharmaceutical industry worldwide to benefit from the most advanced, integrated and complete analytic services capabilities and platforms in biopharmaceutical development, from clone selection through drug approval to commercialization.
In working together with its pharmaceutical partners, the PPS and BioAnalytix teams generate best-in-class analytic data packages and provide scientific, technical and regulatory support to advance, de-risk and accelerate all stages of biopharmaceutical development including biosimilar development at highest quality from clone through clinic.
More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
We support Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity. For developing new biological entities (NBEs) we support customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.
Are you in biopharmaceutical development and looking to uncover everything there is to know about your molecule reproducible, accurate and precisely?
Take a look and contact us!
Biopharmaceuticals are complex molecular entities derived from biological processes. With our broad range of analytical services we offer robust characterization strategies for your product.
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
See here our latest newsletter. The company is constantly informing in E-Mail about latest technology developments,
typical applications, as well as strategic approaches in biotherapeutic development.
Protagen Protein Services (PPS) supports the development of new biopharmaceuticals for better and more effective treatment of diseases such as cancer, chronical diseases e.g.. The safety of the patient is always our leading goal. Quality is key to our business and since the founding of PPS, quality has remained a mainstay of corporate culture. As a GMP-certified contract laboratory with focus on protein analysis PPS has established a quality management system that oversees aspects of our processes and meets the requirements of the EU GMP Guide concerning:
- Precise Instructions
- Traceable Documentation
- Document Control
- Intensive Training Programs
- Comprehensive Inspection Programs
- System for Qualification of Equipment, particularly Computerized Systems based on GAMP