Partnership addresses Protein Life-Span challenges

Proteins therapies, which offer high potential for treating medical conditions such as cancer, may also present storage and distribution challenges that can impact on both accessibility and lifespan. The safety and efficacy of these essential drugs, including monoclonal antibodies (mAbs), hormones, growth factors, interferons and enzymes, are closely tied to their three-dimensional structure, which can be compromised by factors like thermal or mechanical stress, changes in pH or ionic strength and exposure to denaturing agents.

Whilst about 50% of these molecules are marketed in solid form to mitigate these issues, protein chemical and physical degradation can still occur in the solid state, depending on formulation, drying method and storage conditions.  

 In a 3-month collaborative investigation, led by Elizabeth Topp, Principal Investigator of the National Institute of Bioprocessing Research and Training’s Formulation and Stability Group, (Ireland), Applied Materials Inc., paired its expertise in atomic layer coating (ALC) technology with the Institute’s valuable know-how and infrastructure, to the underexplored new field of developing ALC’s for biopharmaceuticals.

Samples containing myoglobin as a model protein and mannitol as a model excipient were coated with nanolayers of aluminium or silica, with results and comparison against uncoated materials suggesting potential pathways to increase product stability, while reducing the loss and deterioration of protein therapeutic drugs.  

"This innovative partnership joins two expert companies in their fields to address a challenge for the biopharma industry. Our study is one of the very few in the field that targets biopharmaceutical formulations and aims to elucidate how the atomic layer coating can improve powder's characteristics related to product stability," explained  Caio Henrique Barros, one of the study's authors. The findings based on the samples used in the test conditions, which showed an improvement of up to 50% (in terms of prevention of aggregation), suggest the use of ALC’s could increase protein powders stability, the study(1) concluded. 

1.Published in American Chemical Society Journal

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