PharmTech Drug Digest 11.20

Whitepapers


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All Whitepapers

Sponsored Content

Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches. Developing standardized factory acceptance test (FAT) execution approaches fit for the current times can allow for consistency across equipment vendors and their biopharmaceutical clients. This article describes pragmatic best practices that would support the momentum for new domestic manufacturing facilities.

Sponsored Content

Since 2020, the CDMO landscape has undergone significant changes. Dearth of fill/finish capacity in the US, exacerbated by COVID and vaccine production, caused market dislocation but also opportunity. With insights gathered through a blind, independent “voice of the customer” industry survey, discover what over 300 decision makers had to say about post-COVID trends and outsourcing plans. Among the intriguing responses captured in the survey – nearly 80% of respondents expressed they were open to, or actively looking for, new CRO/CDMO partners over the past 12 months.

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This white paper highlights Pharma’s data integrity challenge and its impact on manufacturing, and proposes solutions for Pharma’s successful digital transformation journey.

Sponsored Content

Moving a biopharmaceutical product from molecule-to-market is demanding in terms of expertise and capabilities needed throughout the development and manufacturing process. In this white paper, we explore the processes, operations, and customer-focused approach of Emergent CDMO's integrated internal teams, providing efficient organization alongside smooth and timely technology transfer and scale-up, from R&D to GMP manufacturing. Download our latest white paper to learn how partnering with an integrated CDMO can help create an efficient development services framework to achieve your drug substance and drug product manufacturing goals.

Sponsored Content

Understand the role proper wiping technique plays in relaiable and consistent contamination control. Review the right way to quarterfold a wipe as well as the correct technique when wiping a surface to ensure contamination removal.