Resources
Welcome to Simtra BioPharma Solutions’ Educational Resources Center. This library provides educational and informative resources to help you learn more about the latest trends, topics and state-of-the-art solutions for parenterals.
Resources
Baxter Formulation ADC Case Study
This case study describes product development for phase 1 clinical manufacturing of an ADC.
View resourceBioPharma Solutions Capabilities Brochure
BioPharma Solutions knows the high-stakes challenges companies face in today’s parenteral marketplace and works closely with its clients to help them achieve their commercialization objectives. Learn more in this brochure.
View resourceImportance of Assessing Mannitol Crystallinity in Lyophilized Drug Products
When mannitol is used as an excipient in a lyophilized drug product, assessing its crystallinity is important because drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
View resourceFactors to Consider While Selecting Stoppers for Lyophilized Vials
Lyophilization is commonly employed for parenteral drugs that have poor stability in solution.
View resourceMethods for Determining Equipment Capability
This white paper describes two experimental methods of determining “choked flow,” namely the minimum controllable pressure method and choke point method.
View resourceSeasonal Vaccine Manufacturing
The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022.
View resourceHemihydrate Formation Considerations For Mannitol Formulations
Mannitol is a versatile excipient used in freeze-dried injectables in the pharmaceutical industry due to its high eutectic melting point when it is crystallized.
View resourceBaxter Considerations and Options Prefilled Syringes
Convenience, product differentiation, and less waste are great reasons to develop a product in a prefilled syringe.
View resourceBaxter ScaleUp and Tech Transfer
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.
View resourceBaxter Process Development
Identifying the failure points for a product enables the development scientist to design a formulation and process with meaningful ranges supported by data.
View resourceBaxter Best Practices Formulation and Lyo Development
A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
View resourcePharmaceutical Development ADCs
Provides an overview of: ADC structure and function, The development process, Lyo cycle optimization.
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