Formulation Development and DP Manufacturing

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  Developability Assessment, Formulation screening, optimization applying the Design of Experiments (DoE) method and package selection
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  Complete filling and lyophilization process development optimization, scale-up and tech transfer to support clinical and commercial manufacturing
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  Provide comparability and stability studies for formulation development, including long-term, accelerated, and stressed conditions
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  Non-GMP Sample Preparation for non-clinical research using platform or DS formulations
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  Conduct DP manufacturing process characterization studies according to the compliance feasibility in manufacturing process and risk assessment
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  Design and implement process validation and BLA enabling studies of DP manufacturing
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  Performed risk analysis and control for development and commercialization of drug-device combination products. Select injection pen suppliers and collaborate on the development and commercialization of drug-device combination products in compliance with 21 CFR 820.30 and ISO 14971