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.