Protagen Protein Services (PPS) is a leading provider of contract analytical services in protein science. Our long experience in business and the comprehensive spectrum of validated analytical methods ensure the highest quality to our customers in the pharmaceutical, biotech and life science industry.

Besides a large number of new biological entities (NBE), Protagen Protein Services GmbH has successfully supported over a dozen different customers in multiple projects to develop biosimilars with state of the art analytical methods.

Typical studies include:

Additionally to state of the art analytical methods Protagen Protein Services  brings in its regulatory expertise in biosimilar development. For example PPS has developed scientific statistic principles for setting the specifications for the biosimilarity assessment based on multiple quality attributes analyzed.

PPS´s analytical reports on biosimilars and biobetters has been accepted by multiple regulatory bodies worldwide including FDA (USA), EMA (EU) and K-FDA (Korea) during all stages of development: Scientific advice, phase I, phase III to Marketing Authorization.

The process of developing biosimilars includes setting up a suitable production process, analyzing the product derived from this process and comparing it to the marketed drug. This is often combined with stability studies to show comparability also under stress conditions. The comparability of biosimilar and original drug is described as a five-step process:

Five-step process of biosimilar and original drug comparison

The physicochemical characterization and similarity analysis is the building block for a biosimilar development and is compared to the development of new biological entities at even higher importance.

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The amount of possible data reduction for nonclinical and clinical studies depends on how well the molecule can be characterized by state-of-the-art analytical methods, on observed or potential differences between the biosimilar and the reference product. (Published by the Biosimilar working party of CHMP, EMA in Nature Biotech 29 (8) August 2011).

Biosimilars are being developed for a large range of innovator drugs. Examples for such biosimilar developments analyzed at Protagen Protein Services are:

  
 

Your contact for Biosimilars at Protagen Protein Services GmbH

Martin-Blueggel 150x100px

Martin Blüggel

Chief Executive Officer (CEO)
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com