DOE

Large molecule purification presents significant challenges due to their considerable size. For instance, Immunoglobulin M (IgM) molecules, ranging from 900 to 1,000 kD, play pivotal roles in mammalian immune responses and find extensive applications in diagnostics and therapeutics. Purification of such molecules is particularly intricate owing to several factors including their weak Protein A binding sites, limited dynamic binding capacity, and slow diffusion rates.

In this case study, process chromatography application scientist Artur Stanczak presents a two-step mAb purification workflow, comparing multimodal resin alternatives used for the polishing step that occurs after protein A capture. The design of experiment (DOE) data presented characterizes the behavior of multiple mAbs with two different mixed-mode resins. The importance of scale, prior knowledge, and the stage of development will also be discussed. The results of both mixed-mode resin studies and the different DOE approaches demonstrate the ability to achieve high-purity products.

Viral clearance studies are part of a multifaceted approach to ensure biopharmaceutical product safety. To prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency early on during downstream process development. See how a design of experiments (DOE) approach was utilized in this case study to investigate the effect of buffer pH and conductivity on the removal of impurities by an anion exchange (AEX) mixed-mode chromatography resin.

This webinar shows a 2-step mAb purification workflow and compares multimodal options for polishing. See how these methods can achieve high-purity products.

Process development scientists, faced with an increasing number of proteins or complex biomolecules, continuously search for robust purification methods that can be rapidly scaled for manufacturing. What are the optimal purification conditions for high throughput and yield? Which resin or resin combination best purifies the desired protein? How can an efficient, yet cost-effective process be established? The answer: use a systematic screening approach. Read on to learn more.

Infectious diseases and cancers are among the main causes of human deaths worldwide. One successful avenue found to treat these diseases is the large-scale production of therapeutic proteins. As a result, the demand for protein expression hosts and accompanying advanced bioprocessing technologies has increased. Read about a workflow for efficient purification of a low-expressing recombinant protein using mixed-mode resins.

Purifying proteins that are not highly expressed can be challenging. Watch this video to learn about a case study demonstrating an efficient workflow for two-step purification of a low-expressing recombinant protein using mixed-mode chromatography.

Presented by: Akunna Iheanacho, Director of Research and Development at Texcell – North America
Xuemei He, R&D Manager, Chromatograpy Media Chemistry at Bio-Rad Laboratories

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Learn about evaluating viral clearance using a DOE approach with a mixed-mode chromatography resin.

See how you can efficiently reduce identification of optimal protein purification conditions from five days to just 18 hours. All you need is a DOE model and the Multivariable Scouting tool and automation abilities of the NGC Chromatography System.