Resources

BioPharma 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.

Importance 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.

BPS Awards

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.

Baxter Formulation ADC Case Study

This case study describes product development for phase 1 clinical manufacturing of an ADC.

Factors to Consider While Selecting Stoppers for Lyophilized Vials

Lyophilization is commonly employed for parenteral drugs that have poor stability in solution.

Methods 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.

Seasonal Vaccine Manufacturing

The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022.

Hemihydrate 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.

Baxter Considerations and Options Prefilled Syringes

Convenience, product differentiation, and less waste are great reasons to develop a product in a prefilled syringe.

Baxter 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.

Baxter 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.