High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development.
The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.
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1. High-throughput methodology in biopharmaceutical formulation development
2. Early candidate selection and formulation development
3. Preclinical and clinical formulation studies
4. Late-stage and commercial formulation development
5. Analysis of high-throughput data
Vladimir Razinkov is a principal scientist in the Department of Drug Product Development, Amgen Inc., Seattle, WA, USA
Gerd Kleemann Department of Drug Product Development, Amgen Inc., Seattle, WA, USA.
Gerd R. Kleemann is a scientific director in the Department of Drug Product Development, Amgen Inc., Seattle, WA, USA