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Liquid obtained in the fermentation process. Microbiologist with test tubes in his hands. Chemical laboratory equipment. Laboratory bioreactor for the production of vaccines. Pharmacology. | Image Credit: © Grispb – © Grispb - stock.adobe.com

Investigating Bioreactor Contamination, Modeling Contaminant Introduction, and Ensuring Bioburden Test Reliability

By Naveenganesh Muralidharan

April 7th 2025

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

a vial containing clear fluid is shown with a syringe | Image Credit: ©Graham - stock.adobe.com

Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems

By Robert Popilock
Jay Harkins

Felix Brosi

March 10th 2025

This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.

hygiene staff worker in foods and drinks clean factory. working women in water plant industry quality control check. | Image Credit: © Quality Stock Arts - © Quality Stock Arts - stock.adobe.com

Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable Process

By Dayna Turner
Dijana Hadziselimovic

Paul Lopolito
Mary Schanne
Amy Thanavaro
Jeff Felker

October 11th 2024

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

Medical hands holds syringe and vaccine | Image Credit: © Alernon77 - Stock.adobe.com

Optimization of Clarification Step in Pneumococcal Polysaccharide Conjugate Vaccine Manufacturing: Evaluating the Performance of Depth Filters

By Swapan Kumar Jana
Amol Dattatraya Mahajan

Vishal Vijayan
Praveen Kumar Ravichandran
Subhasis Banerjee
Sourabh Kumar

May 7th 2024

This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.

Molecular model of antibody taking part in immune defense. Molecule of immunoglobulin, 3D illustration | Image Credit: © Dr_Microbe - Stock.Adobe.com

Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 2

By Stijn H. S. Koshari
Hong Zhang

Antonio Ubiera
Robert G. Luo

March 2nd 2024

The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.

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