Exploring the Science and Technology Behind Fractionation, Purification, and Downstream Processing: From Discovery to Commercialization

With increasing progress in the life sciences, we are constantly broadening our ability to treat diseases that were previously incurable. This progress however comes with new challenges due to the growing complexity of chemical and biotherapeutic products. Developing and manufacturing the compound of interest in a pure and stable form quickly and efficiently is considered to be business critical if not the decisive factor for success.

The growing complexity of chemical synthesis and biotechnological expression systems is associated with a need for more intensive fractionation and purification downstream processes to ensure sufficient product quality. Increasingly stringent quality criteria for purity are required to secure efficacy, potency, and stability, and prevent toxicity and immunogenicity, especially for biological products such as proteins, vaccines, and monoclonal antibodies. This involves the elimination of any impurities or by-products to achieve the desired compound purity while maintaining the chemical or biological stability and activity in a consistent manner.

The technical challenge of the specificity required for each product and process has led to a tremendous effort to better understand downstream processes and make them more efficient. The more technological options and processes that are available and offered, the more important the expertise in selecting, developing and scaling the most efficient approach from these options becomes.