Posters
BIOSIMILARS: Global Terminology, Strategy & Pathways
Download the Global Terminology, Strategy & Pathways Poster
Features Baxter's Kelly Davis, Regulatory Affairs, Associate Director, and outlines:
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Biosimilar definition
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US and Europe Regulatory Pathways
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Biologics Price Competition and Innovation Act
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351(k) Application Requirements
More Posters by Baxter BioPharma Solutions
More Content From Baxter BioPharma Solutions
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Assurance of the vacuum integrity of freeze - dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations; however, there is currently no generally accepted scientific rationale for establishing acceptance crite…
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Formulation, process, and analytical development for antibody - drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path a…
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This whitepaper discusses considerations for development of a lyophilized biosimilar, as well as a biosimilar case study.
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85+ years of expertise in process and formulation development, technology transfer, and parenteral manufacturing.
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Baxter’s BioPharma Solutions facility in Bloomington, Indiana, was recognized for the fifth time as Best Contract Manufacturing Organization at the annual Vaccine Industry Excellence (ViE) Awards, held during the 2017 World Vaccine Congress in…
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Maximize your molecule's full potential.
Formulation challenges. Clinical supply hurdles. Limited manufacturing capability or capacity. Market fluctuations and demand surges. Lifecycle management. Risk mitigation. Patent expiry concerns.…
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When different drug products are produced in shared facilities, the potential for cross contamination is always a concern.
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A common approach to process development for lyophilized products is to thermally characterize the solution formulation to determine the critical product temperature that should not be exceeded during primary drying. This is conducted using different…
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Complex Sterile Manufacturing with More Than 60 Years of Oncology Experience…
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Formulation and process development for injectable products are typically conducted at laboratory-scale. Laboratory-scale equipment is useful and necessary during development when there is little technical information available and especially when th…
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Experience Makes the Difference
Optimizing lyophilization cycle times and improving stability for complex injectables is a critical component of parenteral product development. With this understanding, BioPharma Solutions established the Lyophiliz…
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Work with a Global Leader in Syringe Fill/Finish
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Baxter has been honored to be recognized globally with various awards and distinctions by the industry, as well as by sustainability, community support and environmental organizations. Download the attached for a sampling, with a full list available…
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A Global Leader in Sterile Contract Manufacturing
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Complex Sterile Manufacturing with More Than 60 Years of Oncology Experience
