Heilbronn, 2018-07-10

The U.S. Food and Drug Administration (FDA) withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars. The FDA withdrew the draft guidance on June 21.

Dortmund, 2014-11-20

PPS is proud to introduce a new HCP service: HCP-GAPexSM. This service is offered in conjunction with our partner Charles River Biopharmaceutical Services.

Read more: PPS expands services for analysis of Host Cell Proteins (HCPs)

Dortmund, 2014-09-23

The Biosimilars Group, an alliance of PharmaLex and 4 partners experienced in biosimilars development, has started operation

In July 2014 PharmaLex GmbH has formed together with the four pharmaceutical service providers Assign International GmbH, Aurigon GmbH, Celonic AG, and Protagen Protein Services GmbH The Biosimilars Group. The Biosimilars Group offers clients effective support in all areas around biosimilars development.

Read more: The Biosimilar Group has started operation

Dortmund, 2013-06-28

Dear Friends and Customers of Protagen Protein Services GmbH,

Protagen Protein Services GmbH (PPS) a leading service provider in Biosimilar analytics is acquired by Zukunftsfond Heilbronn, a major German Venture Capital provider, today.

Read more: Sustainable Growth of Protagen Protein Services GmbH

Dortmund, 2013-05-03

Dear Friends and Customers of Protagen Protein Services GmbH,


the 11th International Symposium of Biosimilar Medicines in London last week showed that Biosimilar development is not a new field per se, but currently gained a lot of importance with a continuously growing number of companies developing Biosimilars worldwide.


Read more: Regulators underline importance of pre-clinical demonstration of Biosimilarity at EGA Meeting...

Dortmund, 2012-11-28

Bei der Entwicklung eines Biosimilars ist die Ähnlichkeitsanalyse zum Originator für den Erfolg entscheidend. Die Anwendung von Hochleistungsanalytik wie zum Beispiel der Protein-Massenspektrometrie liefert auch für strukturell sehr komplexe Biotherapeutika umfangreiche Daten zu mehreren Hundert Qualitätsattributen und damit die Basis der Vergleichbarkeit.

[Hochleistungsanalytik für die Entwicklung von Biosimilars; Martin Blüggel; Pharmazie in unserer Zei 6|2012; 468-473]


Read more: Hochleistungsanalytik für die Entwicklung von Biosimilars

Dortmund, 2012-04-05

Dear Friends and Customers of Protagen Protein Services GmbH, 

More and more plasma derived protein drugs, especially clotting factors like Factor VIII, are no longer produced by plasma fractionation only, but also by recombinant protein expression. The production in transgenic animals or mammalian cell lines leads to a higher product purity and safety, as well as a better reproducibility of the product batches.

Read more: Protagen supports Development of recombinant plasma proteins (II)

Dortmund, 2012-02-28

Dear Friends and Customers of Protagen Protein Services GmbH, 

The business unit Protein Services of Protagen Protein Services GmbH is known for its specialization in regulatory compliant comparability studies for biosimilars as well as for comprehensive characterization of biotherapeutics (NBEs). Our customers can rest assured that we will not only assist in developing analytical strategies according to ICH guidelines, but also bring in our years of experience in the full characterization of biosimilar and originator drugs.

Read more: Protagen supports Development of Biosimilars (I)

Dortmund, 2011-11-24

Dear Friends and Customers of Protagen Protein Services GmbH, 

Protagen Protein Services GmbH entered into a strategic partnership with Charles River Biopharmaceutical Services at the end of last month. In order to provide you with a faster and more comprehensive high quality service, we are just about to take the stage with our colleagues from Charles River. The dates for the mutual GMP audits have already been fixed and the concept of a joint market presence in 2012 is currently underway and will take shape in the near future. The coordination of services in terms of marketing and business development has already begun. Moreover, these measures are specifically supported by the consistent updating of the websites of both companies.  

Read more: Strategic partnership with Charles River starts off

Dortmund, 2011-10-25

Dear Friends and Customers of Protagen Protein Services GmbH, 


BioEurope, one of the most important Biotechnology Business Partnering events of 2011 will be hosted by the City of Duesseldorf and will take place at the CCD Congress Center from October 31 to November 2. This year, Protagen Protein Services GmbH will be represented by two of my colleagues, Dr. Peter Schulz-Knappe (CSO) and Martin Blüggel (COO). 

Read more: Protagen AG at BioEurope 2011

Dortmund, 2011-09-20

Dear Friends and Customers of Protagen Protein Services GmbH, 

Since its invention in 1975, high resolution 2-dimensional gel electrophoresis (2DE) is still the most powerful technology to analyze and compare complex protein mixtures.

Read more: Protagen Customer Support

Dortmund, 2011-09-01

Dear Friends and Customers of Protagen Protein Services GmbH, 

It is a pleasure to inform you that Protagen Protein Services GmbH will present at the EAPB Science to Market Conference focused this year on Challenges in the Development of Personalized Medicine, September 27-28 2011, Berlin (

Read more: Protagen presents at Science to Market 2011

Dortmund, 2011-06-21

Dear Friends and Customers of Protagen Protein Services GmbH, 

The closing of the cooperation contract with Biogen-Idec (press release of March 31, 2011) was an important milestone in the company history. The application of the UNIarray® technology platform for patient stratification of responders and non-responders to Avonex underscores the value of our approach for pharma and biotech companies.

Read more: Protagen Protein Services GmbH at BIO 2011, June 27 - 30

Dortmund, 2011-04-05

Dear Customers and Friends of Protagen Protein Services GmbH,

In the past 20 years, nothing has changed protein analysis as dramatically as the developments in protein mass spectrometry. While the necessary data acquisition and storage capabilities have developed in parallel, data retrieval and interpretation is still a significant challenge requiring not only sophisticated algorithms and software tools, but also expert analysis of the results. Standard software and know-how applied to acquired mass spec data normally yields an identification rate between 50% and 65% − leaving at least 35% of this valuable product information unexplained.

Read more: Competence in Protein Mass Spec Data Analysis