Newsletter | November 9, 2020

11.09.20 -- Overcoming Today's Biopharma Challenges: USP, DSP And COVID-19 Vaccines

 
Commercial Vaccine Manufacturing: How To Prepare For The Rapid Set Up
 

When it comes to rapidly developing a new vaccine during a pandemic, the question also arises as to how it can be quickly scaled up and commercially manufactured. Learn more about recommendations on how to prepare for the rapid set up of commercial vaccine manufacturing.

Can mRNA Disrupt The Biopharma Industry?
 

As companies race to develop a vaccine against SARS-CoV-2, a newer and promising type of vaccine has emerged as a leader — mRNA. But with its revolutionary potential, there also come challenges. Read more about this emerging technology and the role it is playing in the fight against COVID-19.

QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1
 

Quality risk management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its life cycle. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows for the identification and avoidance of possible errors.

Multicolumn Chromatography Process Modeling For Process Performance Prediction
 

Continuous multicolumn chromatography has the potential to reduce resin and buffer usage and the costs of bind and elute processes by increasing process productivity and throughput. This poster shows one approach to generate a predictive performance model for a monoclonal antibody (mAb) process and defines the difference that more process columns provide when intensifying feed concentration.

Cell Line Development Toolbox For The Development Of Intensified CHO Processes
 

Intensified process formats promise improved cost-efficiency in biotherapeutics production through lower cost of goods and increased plant flexibility. This poster outlines a USP toolbox that can be applied to assess the suitability of clones for the intensification and the development of different types of intensified processes.

Rapid Transfer Of Raman Spectroscopy Models From Process Development To Manufacturing
 

This poster describes the rapid transfer of raman spectroscopy models from process development (PD) to commercial manufacturing scale. It details the integration of the BioPAT Spectro solution into the Ambr multiparallel bioreactors and the Biostat STR single-use bioreactors. It then describes the results of process scalability tests and successful model transfer from the Ambr 250 High Throughput system to the 200L Biostat STR.