Newsletter | February 22, 2021

02.22.21 -- When Biopharma Automation Projects Fail: Averting Disaster Through Risk Assessment

 
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Featured Editorial
Industry Insights
A Modern Take On Cell Therapy Logistics

Here are my highlights on an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials, putting patients front and center.

The Human Factor

Single-use systems must be designed with the end user in mind, because user-friendly technologies help ensure the best product performance, reduce the risk of user error, and, ultimately, improve product quality.

End-To-End Thinking During Drug Product Development

In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

Scale Your Bioproduction With Large-Format High-Flow Connectors

Looking to scale up your liquid bioprocessing and decrease transfer times? Learn how high-flow, genderless, large-format connectors make scale and efficiency easy and reliable.

An Optimized Platform For pDNA Purification For Vaccine Production

Purification of pDNA for use as vaccine doses presents several challenges. This application note presents a comprehensive set of technologies that are available to optimize the entire workflow.

How Do Bioreactors Boost Reproducibility?

Differences in cultures from batch to batch often arise due to variability in flask size, flask geometry, shake speed, and shake orbit. Learn how modern bioreactors mitigate that risk.

3 Development Principles For Advanced Biopharma Tubing: Part 1

Tubing is arguably one of the earliest components in pharma to be associated with single-use technology. This paper espouses active risk mitigation and cleaner materials in single-use tubing applications.

Six Strategies To Improve Your Approach To Fill/Finish Manufacturing

Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.

Selecting The Best Transfection Method

In this application note we describe three transfection methods and highlight the Mirus Bio TransIT® transfection reagents and Ingenio® EZporator® Electroporation System.

Faster R&D Of Pharma Production Lines

This use case demonstrates a solution that empowers users by connecting to all relevant data sources to visually represent batches and perform analytics with process data.

Vaccines In The Digital Age: CDMOs, Don’t Miss The Train

Speed, safety, and strict regulatory compliance in vaccine production are essential. This e-book explores how digitally enabling your organization can increase capacity and improve vaccine production.

Challenges In Bulk Drug Substance Logistics: A Glimpse Into The Crystal Ball

Johannes Kirchmair and Thomas Wurm, founders of Single Use Support GmbH, give their insights on the trends, sustainability, climate protection, and the future of single-use bags.

Saving Development Time With A Single Vendor Approach

Watch this webinar to learn how a single vendor with a cohesive global network can help you accelerate the drug development process and reach the market sooner.

Preserving Data Integrity: 21 CFR Part 11 Compliance And Osmolality As A Process Parameter

FDA warning letters due to incomplete data in the pharma and biotech industries can be prevented by ensuring the reliability of electronic records, a process known as “compliance with data integrity.”

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