In the late 1970s, media fill studies began to be used in aseptic processing for the expressed purpose of evaluating sterility assurance levels in filling activities. These initial studies were simplistic. In response to regulatory expectations, the activity grew in sophistication to address perceived vulnerabilities (1). 

Pharmaceutical Technology eBook: Biologics and Sterile Drug Manufacturing

Pharmaceutical Technology eBook: Biologics and Sterile Drug Manufacturing

	When referring to this article, please cite it as J. Agalloco,  “Complications in Process Simulation Execution,"

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Regulators have exaggerated expectations for simulated media fills. 


Complications in Process Simulation Execution

Cell-culture contamination is a common challenge facing cell-culture laboratories, with consequences that range from minor to devastating. Every effort must be made to protect the integrity of cell cultures, both for the experiments that are being performed in the laboratory, as well as to prevent problems later on, downstream. When selected and designed correctly, biological safety cabinets (BSCs) play a critical role in protecting cell cultures, laboratory personnel, and the environment. 

Biologics and Sterile Drug Manufacturing, May 2020, Pages: 34–37

Pharmaceutical Technology eBook: Biologics and Sterile Drug Manufacturing

	When referring to this article, please cite it as author, “Minimizing Contamination During Biopharma R&D,"

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination. 

Minimizing Contamination During BioPharm R&D

Drug developers are increasingly using topical dosage forms for numerous reasons, but several factors must be considered to optimize the API's functionality including excipient selection. Trends and Formulation Strategies for Topical Drugs explores this topic and other areas of interest to developers.


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Complications in Process Simulation Execution

Minimizing Contamination During BioPharm R&D

Trends and Formulation Strategies for Topical Drugs