Large Molecule drugs, Biopharmaceuticals, or Biologics 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. These drug forms offer the ability to treat medical conditions that traditional “small molecule” drug forms cannot. Biologics are comprised of living cells, proteins, tissues, blood components, vaccines, or gene therapies. The requirements for characterizing these drug forms during development and manufacture are the same as for small molecule drugs. This includes the evaluation of extractables and leachables for the container closure system and/or delivery system. Due to the nature of biologics, most are administered through injection or other parenteral route. The U.S. Food and Drug Administration (FDA) Guidance for Industry has categorized parenteral drug forms as having a high concern associated with the route of administration. The FDA has specifically requested leachables studies be performed for parenteral products. Leachables testing involves analyzing the drug product during storage in its container closure system for leachable compounds from the container closure system materials. Developing appropriate leachables methods for characterizing biologic drug forms presents many challenges over small molecule drug forms. BA Sciences will present our experience working with these challenging materials, as well as strategies for conducting E&L studies.
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