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Aggregation Determination

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Creative Biolabs has established a platform to determine protein aggregation based on amino acid sequence and structural features using machine learning algorithms. Protein aggregation is commonly encountered during biopharmaceutical manufacturing process, like during fermentation, purification, formulation and long-term storage. Not only manufacturing process is influenced, but also the protein product profile, delivery condition and patient safety.

Fig 1: Illustration  of the different pathways and energy changes that result in antibody  aggregation. Fig 1: Illustration of the different pathways and energy changes that result in antibody aggregation.

Protein aggregation is caused by intrinsic aggregation propensity and/or surrounding environmental factors, such as pH, buffer, protein concentration and shear-forces. Protein therapeutics are exposed to diverse stresses during manufacture. A typical antibody is secreted from the cell into the medium, which contains buffer constituents, the cells, nutrients for the cells, host-cell proteins (including proteases), dissolved oxygen, and other species. This cellular suspension is held at near neutral pH at temperature above 30 °C for several days, until a sufficient amount of protein has been expressed. The cell-culture fluid is then collected and purified by Protein A chromatography, followed by polishing steps, typically including cation-exchange chromatography (CEX), under buffer conditions of high conductivity, and anion-exchange chromatography (AEX) at high pH. Finally, the protein is formulated by ultrafiltration/diafiltration and filled in its final format. Throughout the production procedures, the antibody solution is pumped, stirred, filtered and is exposed to various materials including glass, plastic and stainless steel. All of these factors can potentially lead to aggregated formation. Protein aggregation gives rise to increase manufacturing costs, lengthen development timelines and reduce the options for protein formulation and concentration determination.

Creative Biolabs guarantees  to reduce the amounts of aggregation in antibodies, max. 5% after protein A purification during the manufacturing process and formulation. We also recommend to avoid candidates with an increased aggregation propensity during promising candidate selection. Protein re-engineering will be considered to decrease the aggregation propensity when it is testified with sufficient experimental results that the aggregation cannot be eliminated only by process control alone. Our platform has already been widely used in a set of antibodies, to design low and high expressing as well as aggregating and non-aggregating antibodies. All the antibodies are characterized experimentally in house in 4-6 weeks as customer desires.

Reference:
BioPharm International, Volume 26, Issue 3




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