title: Immunogenicity of therapeutic proteins. Part 1: impact of product handling.
abstract: The patents of first-generation biopharmaceutical proteins are expiring, creating opportunities for biosimilar products. Unlike conventional generic pharmaceuticals, the development of biosimilar products is far more complex and requires more than a simple demonstration of pharmacological bioequivalence to establish efficacy and safety. The main concern with biosimilar products, as for any therapeutic protein, is immunogenicity and with it the potential for serious clinical sequelae. In the absence of adequate predictors of immunogenicity outside the clinical trial setting, biosimilar products should be evaluated in the same way that any novel pharmaceutical is evaluated. Herein, the factors involved in breaking host tolerance following administration of a therapeutic protein are discussed. The impact of product handling on immunogenicity is considered in the context of some hard-fought lessons that have helped to shape the current era of biopharmaceutical manufacturing, packaging, distribution, storage, and quality assurance.
authors.affiliation: Pharmaceutical Technology, Global Biologics Supply Chain LLC, HTD 6-2, Horsham, PA 19044, USA. bsharma@gbsus.jnj.com
authors.forename: Basant
authors.initials: B
authors.lastname: Sharma
mesh_terms: D006801:Humans; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins / Q000276:immunology* / Q000494:pharmacology*; D013048:Specimen Handling / Q000009:adverse effects*; D013696:Temperature; D013997:Time Factors
chemical_list: D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins