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Biopharmaceuticals and Biotechnology

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by Rebecca Stauffer, PDA | Jul 08, 2019

Study Looks at Endotoxin Testing for Snake Bite Antivenoms Produced Using Horse Plasma

Find out how the limulus amebocyte lysate test can serve as an end-product endotoxin test for snake antivenom in the July/August issue of the PDA Journal of Pharmaceutical Science and Technology.

Research

  • “Factors Affecting Measurement of Equilibration Time of Dry Goods Loads in Autoclaves,” Soham Shah, et al.
  • “A Validation study of the Limulus Amebocyte Lysate test as an end-product endotoxin test for Polyvalent Horse Snake Antivenom,” Norhan Saif Sheraba, et al.
  • “A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems-Part 2,” Anant Navanithan Sharma, et al.
  • “Quality Risk Management Competency Model - Case for the need for QRM Competencies,” Ghada Haddad and Anne Greene

Technology/Application

  • “Comparative Leachable Study for Glass Vials to Demonstrate the Impact of Low Fill Volume,” Bernhard Hladik, et al.
  • Enabling Robust and Rapid Raw Material Identification and Release by Handheld Raman Spectroscopy,” Thomas Earl Matthews, et al.
  • “Provable Data Integrity in the Pharmaceutical Industry based on Version Control Systems and the Blockchain,” Valentin Steinwandter and Christoph Herwig

Commentary

  • “What Does It Really Look Like to Properly Address a ‘Human Error Problem’ in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance,” Cliff Berry, et al.

Conference Proceeding

  • “PDA Biosimilars Workshop Report (27-28 September 2018) - Getting It Right the First Time for Biosimilar Marketing Applications,” Stephan Krause, et al.
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