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05.25.21 Are You Approaching LIMS Validation Correctly?
Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights
02.10.21 Regulatory Process Planning For Oral Solid Drug Development
Throughout a drug product development program, it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist, discusses what needs to be considered during product development in preparation for commercial manufacture.
Navigating your oral solids project from development through commercial manufacture can be a challenging path. This first installment in a two-part series examines the importance of technical groundwork and understanding excipients in the early stages of an oral solid s development project.
In your quest to meet the regulatory requirements for your oral solid project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. In this article experts discuss common regulatory challenges and how to approach