Biopharmaceuticals: A Growing Class
Valued for their high potency, safety, and ability to modulate therapeutic effects beyond that of traditional small molecules, biopharmaceuticals are the fastest-growing class of pharmaceuticals in the world today. Over one third of drugs currently in development are biopharmaceuticals, with over 900 biopharmaceuticals in clinical development or under review by the FDA, excluding pre-clinical candidates and already-approved products. Approved biopharmaceuticals comprise a rapidly growing $100+ billion market, expected to surpass $160 billion by 2015. Biopharmaceuticals are typically high cost drugs, with some treatment courses approaching patient costs in excess of $100k.
Current State of the Art: Biopharmaceutical Purification
Traditional small molecule drugs are produced by means of a series of discrete chemical and biocatalyzed reactions yielding single chemical entities that can be thoroughly characterized. In contrast, biopharmaceutical products are much more complex molecules and are mainly produced within genetically engineered cellular host systems such as microbial, fungal, and mammalian cells at large volumetric scales ranging from 100’s to 10,000’s of liters. The result from this production process is a complex mixture that contains liquid medium, host cells, host cell material, and the desired therapeutic product typically at concentrations between 0.05-1.0% by weight.
After the production phase, the biopharmaceutical target must be liberated or separated from the production host cells and purified from the complex mixture of liquid medium and host cell material in order to achieve the very high molecular drug substance purity stipulated by FDA & EMA standards. To accomplish this, bioprocess professionals invoke a series of separation techniques based on the unique chemi-physical properties of the target molecule in contrast to host process impurity molecules (ie, size, ionic charge, hydrophobicity, etc). Each processing step must maintain the biological target’s biological integrity, while minimizing losses from each separation step. To this end, downstream purification processes might utilize 3-6 unique chromatography and filtration steps in order to arrive at the pure or final characterized product. The total purification cost is aggregated from the series of chromatography and filtration steps, which all require trained personnel, large volumes of highly purified water, equipment, custom facility designs, and consumable reagents.
As a candidate biopharmaceutical progresses through clinical trials and larger production quantities are required, additional investment is needed to incrementally refine the purification processes further to achieve scale and purity standards within robust operational and quality frameworks, and satisfy economical production cost boundaries.
Avitide’s custom biopharmaceutical purification service provides customers a direct line of sight to a clinical scale purification solution. Avitide’s platform enables clients to realize the advantages of affinity purification technology to reduce time scales, cost of goods, and facilities costs of biopharmaceutical purification and also reduce risk associated with traditional scale-up procedures.