Newsletter | October 13, 2021

10.13.21 -- Efficient Biosimilar Commercialization: Lessons For Biosimilar Developers

 
Bioprocess Development For Biosimilar Production: Insights From Alvotech
 

Establishing robust upstream bioprocesses and scaling them up to larger volumes are critical steps in biosimilar development. In this interview with Alvotech, they share insights on which process parameters are key to ensure consistent product quality and how automation can make the scientists’ lives easier.

Biosimilar Development Process To Production
 

Managing scale-up and process transfer from development to manufacturing equipment is a challenging task. In the development of biosimilars, small bioreactors are used to save time, material, and resources. In the case of large-scale production, it is important to show that the results of the small-scale system can be transferred to larger scales.

Increasing Efficiency Through Process Analytical Technology
 

In biologics production, software is needed to monitor and control the process and analyze process data. Inline analysis of process parameters reduces the manual workload and facilitates the implementation of automated feedback control loops. Presented here are strategies for inline process analytics that aim at automated feed control in an upstream bioprocess.

Improving Antibody Production Workflows With A Pilot/Production Bioreactor
 

An effective scale-up strategy is required to ensure the reproducibility of both cell culture growth and antibody yields at large working volumes. This study details the use of the Scale Up Assist feature of the BioFlo 720 Bioreactor Control System to scale CHO batch cultures from 3 L to 10 L single-use vessels and from a 10 L to 250 L single-use bioreactor (SUB) bag.

Critical Software Features For Automated Process And Data Control
 

Jörg Schwinde, Ph.D., Key Segment Manager at Eppendorf, discusses current gold standards for upstream bioprocess analytics for improved product quality and process efficiency. Topics include an overview of today’s key process-development challenges, parameters to consider in antibody upstream bioprocess development and bioprocess hardware and software capabilities need to aid bioengineers.