High-Throughput Formulation Development of by Vladimir I. Razinkov, Gerd Kleemann

By Vladimir I. Razinkov, Gerd Kleemann

High Throughput formula improvement of Biopharmaceuticals: functional advisor to tools and Applications offers the most recent advancements and data at the technological know-how of good and secure drug product formulations, proposing a finished overview and special description of contemporary methodologies within the box of formula improvement, a technique beginning with candidate and pre-formulation screening in its early improvement part after which progressing to the refinement of sturdy formulations in the course of commercialization within the later stages of development.

The identify covers themes similar to scan layout, automation of pattern practise and measurements, high-throughput analytics, stress-inducing equipment, statistical research of huge quantities of formula examine information, rising applied sciences, and the presentation of a number of case reviews, besides a concluding summary.

  • Presents functions of high-throughput methodologies to speed up drug formula development
  • Provides the most recent applied sciences within the field
  • Includes key statistical techniques, resembling layout of test and multivariate information analysis
  • Written through hugely revered formula improvement specialists

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Additional resources for High-Throughput Formulation Development of Biopharmaceuticals. Practical Guide to Methods and Applications

Example text

Studies have shown that compact devices can deliver insulin in the form of an aerosol by inhalation [105]. Aerosol formulations, as a route of delivery, are interesting. Due to the large surface of the aerosol droplets, protein is easily absorbed on the interfaces of different biological tissues. The number and types of excipients that are accepted for pharmaceutical and biopharmaceutical formulations and their administration is regulated by the regulatory authorities. Any new stabilizer requires extensive testing to comply with regulatory safety requirements.

Immunol. Methods 96 (2) (1987) 271–278. [7] V. Kumar, N. N. S. Kalonia, Phase separation of proteins by poly-ethylene glycols: implications in preformulation and early stage formulation development, Am. Pharm. Rev. 14 (7) (2011) 26–33. J. Gibson, K. J. Mcfadyen, E. Cash, P. D. , Application of a high-throughput screening procedure with PEG-induced precipitation to compare relative protein solubility during formulation development with IgG1 monoclonal antibodies, J. Pharm. Sci. 100 (3) (2011) 1009–1021.

The separation of N-glycans was achieved by a porous graphitized carbon column on a chip and the samples were analyzed by electrospray ionization hybrid quadrupole time-of-flight mass spectrometry. The library helps to identify N-glycan structures in a high-throughput manner by 30 High-Throughput Formulation Development of Biopharmaceuticals allowing the analyst to compare measured retention times and accurate masses with those listed in the database. As demonstrated by this study, most N-glycans are structurally very similar and only their relative abundance is molecule specific.

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