PDA New England Chapter Webinar: Extractables and Leachables for Biologics

Biologics (Large Molecule drugs, Biopharmaceuticals) are a growing class of drugs in the pharmaceutical industry. These drug forms include pharmaceutical products that are manufactured in, extracted from, or synthesized from biological sources. Biologics are comprised of living cells, proteins, tissues, blood components, vaccines, or gene therapies. The requirements for characterizing these drug forms, including for E&L, is the same as for small molecule drugs. Due to the nature of biologics, most are administered through injection or other parenteral routes. The U.S. Food and Drug Administration (FDA) has categorized parenteral drug forms as having a high concern associated with the route of administration that require leachables testing. Developing appropriate leachables methods for characterizing biologic drug forms presents many challenges over small molecule drug forms. Mr. Hill, an analytical chemist, will present his experience working with these challenging materials, as well as strategies for conducting E&L studies.