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Our services include pre-formulation studies to screen the interaction of proteins with excipients through analytical techniques like RP-HPLC, SEC HPLC, Dynamic Light Scattering, and UV spectrophotometry. Studies are carried out to determine the parameters affecting the purity, potency, safety & efficacy of the drug and test compatibility of drug with the manufacturing equipment and primary packaging material, in accordance with the regulatory requirements.
We undertake development and optimization of Lyophilization cycles for biopharmaceuticals. Advanced analytical tools are applied to find out the thermodynamic properties of drug substance to deliver the efficient, scalable transferable process to resulting in optimal product stability characteristics. We also have capability of developing novel drug delivery systems for biopharmaceuticals.
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