Whitepapers

When life science facilities are forced to shut down, or operate with fewer staff, it exposes a severe lack of capabilities to monitor critical assets and environments. This white paper states critical parameters in a lab or life science facility that should be monitored by a 24/7 real-time data acquisition system.

Validation is an important process to ensure cleanrooms meet specific standards. A comprehensive cleanroom monitoring strategy combines data acquisition, analysis, and reporting to support compliance efforts and protect valuable scientific work. Read how continuous monitoring supports validation and compliance in our white paper.

How do you ensure an environment remains controlled at all times? What parameters must be monitored to ensure scientific assets are free of the threat of contamination? Learn this and more in this eBook.

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.

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.

Learn how Gibco™ Rapid Prototyping can help idenitfy the most feasible cell culture media for cGMP scale-up.

This session will address ways to help streamline media manufacturing, including rapid, small-scale non-cGMP media prototyping and proprietary media formulation outsourcing options.

Learn how Gibco™ Rapid Prototyping can accelerate your journey to cGMP

In this brochure, learn about the Eppendorf Centrifuge CR22N and CR30NX, the everyday centrifuges perfect for a wide range of applications. Read about unique features, technical specifications, common rotor options and more.

This application note describes production of a recombinant protein using a workflow for culturing and harvesting bacteria and purifying proteins. The Eppendorf Centrifuge CR22N or CR30NX is used in combination with the Innova S44i Shaker for a high yield of functional recombinant protein.

This white paper introduces a method for reducing harvesting time of yeast, bacteria, or cell cultures by up to 32% using the Eppendorf Centrifuge CR22N or CR30NX with unique triangular 1.5 L bottles.

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

In this industry brief, we examine key challenges that exist in the biopharma industry, particularly in the early phases of commercialization, and review ways organizations can address them.  

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.

This article presents a detailed mapping of processes and data flow to identify the gaps associated to Data Integrity for GxP processes managed by computerized system and/or manually.