Protagen Protein Services Expands Analytical Services for Biosimilar Development

Protagen Protein Services (PPS), a contract research organization (CRO) in protein analytics, has recently added a new differential scanning calorimetry (DSC) device as part of its ongoing investment in new analytical techniques for protein characterization.

The development of a biopharmaceutical product succeeds or fails on the stability of the protein on which it is built, according to the company. Protein stability is considered a critical parameter during manufacturing, production, formulation, long-term storage, efficacy, and delivery to patients, PPS reports.

With the new DSC device, PPS can now offer DSC analysis that requires five times less sample amount. The company is also able to determine the temperature at which denaturation of the protein begins: T onset of melting. This additional information to the melting temperature of protein domains provides further insights to the overall stability of the biotherapeutics being analyzed.

The new method extends the company’s capabilities to obtain additional complementary results for demonstrating biosimilarity and batch-to-batch comparability. The method also offers developers a quick stability assay to identify biotherapeutics with good stability potential and enables the determination of conditions that maximize shelf-life.

The development of highly stable protein therapeutics will enable the production of drugs more cost-effectively and with fewer challenges during the manufacturing process. In addition, these biotherapeutics are more likely to remain functional during formulation and storage without any aggregation or alteration, according to the company.

Source:Protagen Protein Services