Resources
Welcome to 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 Biosimilars Case Study
This paper discusses important development considerations of a lyophilized biosimilar as well as providing an example/case study with outcome/results.
DownloadBaxter Formulation ADC Case Study
This case study describes product development for phase 1 clinical manufacturing of an ADC.
DownloadFactors to Consider While Selecting Stoppers for Lyophilized Vials
Lyophilization is commonly employed for parenteral drugs that have poor stability in solution.
DownloadMethods 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.
DownloadSeasonal Vaccine Manufacturing
The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022.
DownloadHemihydrate 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.
DownloadBaxter Considerations and Options Prefilled Syringes
Convenience, product differentiation, and less waste are great reasons to develop a product in a prefilled syringe.
DownloadBaxter Cyto/NonCyto
With the advent of more product niches and often lowered production quantities, facilities that are experienced and versatile in handling cytotoxic, highly potent, and non-cytotoxic oncology products can present a valid option.
DownloadBaxter 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.
DownloadBaxter 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.
DownloadBaxter 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.
DownloadPharmaceutical Development ADCs
Provides an overview of: ADC structure and function, The development process, Lyo cycle optimization.
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