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.
Faster, more accurate characterization of biomolecular stability using Differential Scanning Calorimetry (DSC)
Heilbronn/Dortmund July 2018: 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 Calorimtry (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.
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Key words: Biosimilars/protein analysis/drug development/analytical service
About Protagen Protein Services GmbH (PPS):
PPS is a world leading CRO in protein analytics and its application to GMP-compliant characterization of protein therapeutics. 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 Tel.: +49 7131 74504-0
Marketing Manager Fax: +49 7131 74 504-299
Protagen Protein Services GmbH E-Mail: marketing@ProtagenProteinServices.com
Inselwiesenstraße 10
74076 Heilbronn, Germany
