Bioprocessing Application Notes & Case Studies

1. Evaluation Of Novel Cell Retention Technology And Cell Culture Media For N-1 Perfused Seed Train 7/19/2020

   Perfusion operations deliver high density cell cultures that alleviate the burden of processing large production bioreactor volumes while increasing manufacturing flexibility. Introducing perfusion to your seed train makes it possible to inoculate a higher quantity of cells for one or more production bioreactors, thus increasing process efficiency. Read our application note to learn more on the use of cell retention technologies to enable perfusion processes.

2. Blazar™ Platform 7/15/2020

   The Blazar™ platform provides researchers with accurate and highly sensitive viral detection in just days. Combining the breadth of detection of NGS with the speed and sensitivity of PCR, Blazar™ relies on degenerate PCR primers for coverage of more than 5000 viral variants. By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional PCR methods.

3. Radiance® Label-Free Monitoring Of AAV Transfection In HEK293 Cells Using Laser Force Cytology™ 7/13/2020

   There are several challenges related to the development and manufacturing of AAV-based processes, including characterization, quantification, and downstream purification. LumaCyte’s Radiance® instrument, which uses Laser Force Cytology™ (LFC) to measure the intrinsic biophysical and biochemical properties of single cells, has the potential to improve the characterization of cell-based AAV transfection and production, improving the efficiency and accuracy of both processes and shortening development time.

4. Establishing Parameters For Success 7/8/2020

   Applying clinical supply management expertise to overcome inventory challenges for a complex, global study. A CRO customer and clinical sponsor both lacked an unblinded supply management role to oversee Interactive Response Technologies platform (IRT) supply strategies and monitor clinical supply inventory levels for a complex global study.

5. Expediting Path To Clinic With OptiForm® Total Supply 7/8/2020

   MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. Learn how Catalent provided integrated formulation development, clinical trial material manufacturing, and supply and distribution services to ensure successful delivery of the kits to MGB's patients.

6. Eshmuno® CMX — A Novel Mixed Mode Cation Exchange Resin For The Purification Of Glycoproteins 6/29/2020

   With the outbreak of COVID-19, the most severe pandemic in the 21st century so far, a feverish search for therapeutic treatment and vaccinations has just started. A substantial number of approaches are focusing on the coronavirus S glycoprotein, a surfaceexposed protein that mediates the entry of the virus into the host cells. The aim of this technical note is to provide a description of the capture and subsequent purification of glycoproteins.

7. Optimal Bioreactor Inoculum Preparation In Shake Flasks With Automated Seed Inoculation, Conditioning And Online Monitoring 6/25/2020

   The preparation of an optimal inoculum is crucial for the success of any bioprocess with regard to lag-times, growth kinetics, productivity and prevention of contaminations. Using S. cerevisiae as an example, we present an integrated approach for optimal inoculum preparation in shake flasks with automated seed inoculation, conditioning and online monitoring, which leverages the early stages of culture expansion to a level of bioprocess monitoring and control that has until today only been accessible in later stage stirred tank bioreactors.

8. A Guide To Pichia Pastoris Fermentation In Single-Use Stirred-Tank Bioreactors 6/25/2020

   Pichia pastoris is a methylotrophic yeast largely used for heterologous protein production in biotechnology and the eukaryotic P. pastoris is capable of carrying out post-translational modifications, such as glycosylation, and meanwhile secreting the protein of interest. P. pastoris displays much faster growth and requires a less expensive growth medium, making it ideal for cultivation in bioreactors. This paper details the procedure of Pichia pastoris fermentation in a BioBLU® 3f Single-Use Bioreactor controlled by a BioFlo® 320 bioprocess control system.

9. Seamless Integration Of Glucose Control Using Raman Spectroscopy In CHO Cell Culture 6/25/2020

   In upstream processes, one compound of great interest to monitor is glucose, and specifically, being able to control its concentration during the process. Such a monitoring leads to process quality improvement, including glycosylation of the product of interest. In this study, a Raman analyzer has been successfully used to implement a feedback control loop in a CHO cell culture based on glucose concentration.

10. Leader In Restorative Cell Therapies Embeds Skyland PIMS® As Process Knowledge Base From Clinical To Commercial Manufacturing 6/25/2020

    A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. By implementing Skyland PIMS into their manufacturing plan, the drug developer is able to securely manage critical data in a collaborative, cloud-based, 21 CFR Part 11 compliant workspace.