Protagen Protein Services expands analytical Service Spectrum in Biosimilar Development Support
February 20, 2019 – Pharmaceutical –
Heilbronn/Dortmund February 2019: The success or failure of the development of a biopharmaceutical product is also governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, formulation, long term storage, efficacy, and delivery to patients.
To meet our customer demands now and in the future, PPS always invests in new analytical technique and recently added a new Differential Scanning Calorimetry (DSC) device.
Now we can offer the DSC analysis requiring five times less sample amount. Furthermore we are able to state the temperature at which denaturation of the protein begins: T onset of melting. This additional information to the melting temperature of the protein domains provides further insights to the overall stability of the analyzed biotherapeutic drug.
The new method extends our capabilities to obtain additional complementary results, for demonstrating Biosimilarity and Batch-to-Batch Comparability for the benefit of our customers. As additional value it offers developers a quick stability assay to identify biotherapeutics with good stability potential and enables to determine the conditions that maximize the shelf-life of a biotherapeutic.
As we help to develop highly stable protein therapeutics the production of drugs will become more cost-effectively, may face fewer challenges during the manufacturing process, and they are more likely to remain functional during formulation and storage without any aggregation or alteration.
Besides the new DSC method it is outmost important to also analyze the protein research object with other stability indicating methods. Learn more from our broad analytical spectrum at www.protagenproteinservices.com.
Key words: Biosimilars/protein analysis/drug development/analytical service
About Protagen Protein Services GmbH (PPS):
Protagen Protein Services (PPS) is a world leading CRO and recognized expert in mass spectrometry methods for analytical services in protein science. Over 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. PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity. For developing new biological entities (NBEs) PPS supports customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.
Contact:
Tobias Timtner
Marketing Manager
Protagen Protein Services GmbH
Inselwiesenstrafle 10
74076 Heilbronn, Germany
Tel.: +49 7131 74504-0
Fax: +49 7131 74 504-299
Protagen Protein Services (GmbH), Inselwiesenstraße 10, D-74076 Heilbronn
