Baxter BioPharma Solutions approaches formulation and process development with the intention of identifying the failure points for the product. Knowing where the product fails enables the development scientist to design a formulation and process with meaningful ranges supported by data. This...
Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical. Outsourcing of drug product manufacturing to a contract manufacturing organization with experience in handling different products in...
Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The...
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