The storage of high-quality biopharmaceuticals is a major challenge for the industry. Proteins are easily affected by changes in ambient conditions and react sensitively to changes in their environment. The complex three-dimensional protein structure is held together by weak, intra-molecular interactions and is therefore particularly delicate.
The native folding of protein substances is essential for their efficacy: only if a protein is correctly folded will the right molecules be bound. Changes in the structure will have fatal consequences; in certain cases, they do not only result in a loss of efficacy, but may even cause pathological effects.
This means the process of storing an active protein substance must be the result of an exceptionally careful and sophisticated design process and all influencing factors must be known since the substance will often need to be stored for years.
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