Newsletter | July 31, 2019

07.31.19 -- Next Steps For Serialization In The Biopharma Supply Chain

 
Featured Editorial
Next Steps For Serialization In The Biopharma Supply Chain
 
By David Colombo, Valerie Eng, and Sarath Ramakrishnan, KPMG

The industry has made unprecedented progress and addressed several challenges to ensure compliance with bio/pharma serialization and traceability requirements within each market. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the supply chain must systematically adopt serialization in their normal business operations.

Experience, Capacity Impact Sterile Injectable Drug Product Outsourcing

In Q2 2018, ISR asked 43 outsourcers of sterile injectable drug product manufacturing to select from four different reasons that manufacturing may be split between in-house and external resources. Here's how respondents rated their organization’s experience and capacity with respect to outsourcing aseptic fill-finish. 

Industry Insights
Guide To Bioprocess Modes: Batch, Fed-Batch, And Continuous Fermentation
Application Note | By Ying Yang and Ma Sha, Eppendorf

In this application note, we explain the differences between batch, fed-batch, and continuous fermentation and how these influence culture growth. In our examples we studied E. coli fermentation at bench scale. The principles may also apply to bioprocesses using other microbes or mammalian cells, at both smaller and larger scales.

Environments Where Bacterial Endotoxins Can Be Found
Article | FUJIFILM Wako Chemicals U.S.A. Corp.

There are many environments that may be contaminated with bacterial endotoxins, since Gram-negative bacteria are characterized by their great level of ubiquity.

Tube Welders vs. Aseptic Connectors
Article | CPC

Tube welding versus using aseptic connectors: As with any debate, there are strong opinions on both sides. Following are some factors to consider that may tip the scale in favor of aseptic connectors.

Modular Bioprocessing Alleviates Drug Manufacturing Woes
Case Study | GE Healthcare Life Sciences

Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers but also many different experts in various industries.

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