SPI Pharma SPI’s mission is to provide materials and services that enable customers to solve formulation problems, achieve differentiation, and gain speed to market. We offer a collaborative problem solving approach with our...
the stability of a lyophilized igG1 monoclonal antibody was investigated using suboptimal levels of the lyoprotectant, sucrose and the incorporation of the plasticizer, sorbitol. after lyophilization, aggregation and sub-visible particle formation in the reconstituted formulations were evaluated by a number of techniques chosen to encompass a wide range of aggregate sizes. these methods included ...
Pharmaceutical manufacturers are seeking ways to maintain and improve product quality while reducing manufacturing costs, including in the analytical test- ing of raw materials. Movement toward 100% inspec- tion of raw materials as well as increased production volumes and the desire for lean manufacturing are additional motiva- tions to find more cost-effective testing technologies. Raman ...
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