Biopharmaceuticals are medical drugs produced using biotechnology. They are typically proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in-vivo diagnostic purposes, and are produced by means other than direct extraction from a native biological source.
Country or regional approvals to use a biopharmaceutical drug can require several years of clinical trials, including trials with human volunteers. After approval and release to market the drug continues to be monitored for performance and safety risks.
The manufacture of the drug must satisfy the "current Good
Manufacturing Practices" regulations of the local regulatory body where the drug is in use (FDA for USA for instance). The drugs are typically manufactured in a clean room environment a under strict set standards.
Purolite Life Sciences products are used in the purification of these biopharmaceutical drugs and therefore also must be manufactured under strict conditions and standards. In addition, because drugs are on the market for many years, security of supply during this period is of utmost importance.
Small molecule drugs are not typically regarded as "biopharmaceutical" by the industry
Gel Filtration of Macromolecules
Ion Exchange Chromatography
Production of Customized Affinity Chromatography Media
Protein A Chromatography