Bioprocessing Application Notes & Case Studies

1. Enhanced CE-SDS Analysis With Maurice’s CE-SDS PLUS System 1/26/2021

   CE-SDS is a standard methodology for characterization of biotherapeutic proteins and confirmation of product purity. Maurice and Maurice S. deliver this analysis in an easy-to-use format that significantly simplifies your workflow and reduce hands-on time and the chance of user error. In addition the PLUS system preserves the same features, and in addition enables enhanced sample stability and data consistency throughout a batch.

2. Comparing SDS-PAGE With Maurice CE-SDS For Protein Purity Analysis 1/26/2021

   The accurate and quantitative analysis of product purity is a fundamental component of effective development of a biotherapeutic protein. But without consistent techniques and high-quality, reproducible results, it is difficult to correctly assess the product’s efficacy and/or safety, potentially delaying, even jeopardizing, its approval. In this application note, we compare Maurice™ CE-SDS with SDS-PAGE in parallel and reveal the advantages of Maurice CE-SDS over SDS-PAGE for routine product purity characterization.

3. Batch Tracking & Cycle Time Analysis 1/26/2021

   Batch manufacturing of chemicals entails many distinct phases. A large chemical manufacturer was struggling to analyze batch phase times for process improvement using Excel spreadsheets. Utilizing Seeq, process engineers can use process variables, formulas, and string signals to separate each batch into phases. This enables them to Identify the “best” cycle time for each phase and tune production variables (such as adjusting pump speeds or adding catalysts sooner) to replicate the ideal cycle.

4. Batch Quality Prediction 1/26/2021

   Predicting the quality of a batch has traditionally been a challenge for drug manufacturers. The usual process is to take samples while a process is running and send it to the lab for analysis then waiting on the results. A large molecule pharmaceutical manufacturer was struggling to predict batch quality results in near real-time. They found a solution that gave them a better way to predict batch quality and enabling process optimization.

5. icIEF Analysis Of Adeno-Associated Virus (AAV) Proteins For Gene Therapy 1/25/2021

   As with all therapeutic drugs, product characterization is of utmost importance in order to ensure drug safety and stability. For gene therapies, this includes characterizing the delivery vector before the drug is packaged. In this study, we demonstrate how imaged-capillary isoelectric focusing (icIEF) can be used to characterize the charge heterogeneity of AAV vectors to ensure product stability and identity.

6. Characterization Of Adeno-Associated Viral (AAV) Vector Proteins Using Maurice CE-SDS 1/25/2021

   To support the rise of AAV vectors in the clinic, technological solutions that afford robust quality control assays are essential for implementing Good Manufacturing Practice (GMP), meeting regulatory requirements and ensuring the clinical quality, safety and consistency. In this application note, we demonstrate how capillary electrophoresis sodium dodecyl sulfate (CE-SDS) can ensure these requirements are met. The state-of-art Maurice™ system delivers CE-SDS analysis with excellent specificity, linearity, repeatability and quantification of your AAV samples, and with the ability to detect impurities.

7. Determining Residual Bead Count: Application Of Micro-Flow Imaging To CAR T-Cell Manufacturing 1/25/2021

   Residual bead count is typically determined manually by the naked eye and microscopy. But this approach is highly limited in its ability to accurately discern beads from cells and other potential in-process impurities, resulting in reporting uncertainties that risk regulatory approval. In this application note, you’ll see how automation via image-based Micro-Flow Imaging™ (MFI) technology gets you the quantitative and morphological data you need to have confidence in distinguishing between beads, T cells or other potential contaminants.

8. CE-SDS Analysis Of A NISTmAb Reference Standard Using Both Maurice And The SCIEX PA 800/PA 800 Plus 1/22/2021

   Regulatory agencies require that all biopharmaceutical companies monitor critical quality attributes for any monoclonal antibody therapeutic product. CE-SDS is a commonly used method as it provides purity and identity information required by the FDA. Regulatory agencies require that all biopharmaceutical companies monitor critical quality attributes for any monoclonal antibody therapeutic product. CE-SDS is a commonly used method as it provides purity and identity information required by the FDA.

9. Apparent Molecular Weight On CE-SDS And SDS-PAGE 1/22/2021

   While CE-SDS has significant advantages over SDS-PAGE, it has been observed that there can be discrepancies in apparent molecular weight (MW) between the two methods. Although CE-SDS and SDS-PAGE are typically not intended for high-resolution MW determination, many of their applications require a reasonable estimate of apparent MW. This Technical Note highlights relevant peer-reviewed publications that address these factors for comparing MW between CE-SDS and SDS-PAGE.

10. Measuring Oxygen Transfer Rate (OTR) Of The Eppendorf Fermentation Vessels 1/21/2021

    OTR is a very important parameter of fermentation vessels which affects the selection, design, and scale-up of a bioprocess protocol. Here we describe in detail how we measure the OTR of an Eppendorf fermentation vessel using the industrial standard sulfite depletion method. This short protocol can serve as a reference for the bioprocess professionals who want to perform OTR measurements of Eppendorf’s large collection of fermentation vessels.