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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
02.23.21 Cleaning Of Multipurpose API Plants: 9 Rules To Follow
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Grant Mordue
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an API plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
A Stepwise Approach To CMC Planning For A Biologics License Application
Source: Lonza Pharma & Biotech
By Jason Osman, Senior Director, Head of Proposals, and John McGuire, Global Head of Regulatory Affairs, Lonza Biologics
The complexity and diversity of today’s pipelines are creating new challenges throughout every stage of development, requiring a wide range of expertise to ensure a drug can be produced consistently from batch to batch. While safety, quality, and efficacy are the primary focus during this journey, manufacturers must also consider the regulatory requirements they need to meet in order to bring their drug to market. A critical step in reaching this milestone is designing a chemistry, manufacturing, and controls (CMC) strategy that gives regulators confidence that the development and manufacturing plan outlined for your product is properly tailored to meet its unique characteristics and needs.
02.04.21 Strategies For Achieving Biologic License Application
Creating a CMC strategy offers many challenges and requires expertise and resources to successfully execute it. This webinar focuses on the critical CMC elements of a product’s life cycle and the regulatory submissions support and strategy necessary for a successful BLA application.
Developing an effective CMC strategy requires a thorough understanding of a drug and its unique characteristics in order to design a manufacturing process that ensures consistency throughout the product’s life cycle. Here, Dr. Jason Osman and Dr. John McGuire answer attendee questions from a recent webinar about a structured approach to developing a CMC strategy.