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.

A monoclonal antibody (mAb or moAb) is an antibody made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Coronavirus. 3d render| ©Naeblys - stock.adobe.com

Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 1

By Stijn H. S. Koshari
Hong Zhang

Antonio Ubiera
Robert G. Luo

February 2nd 2024

The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters, including for enhanced upstream processes such as those incorporating high cell density perfusion.

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