ABSTRACT
The World Antibody-Drug Conjugate (WADC) Summits organized by Hanson Wade are currently the largest meetings fully dedicated to ADCs. The first global ADC Summit was organized in Boston in October 2010. Since 2011, two WADC are held every year in Frankfurt and San Francisco, respectively. The 2013 WADC San Francisco event was structured around plenary sessions with keynote speakers from AbbVie, Agensys, ImmunoGen, Immunomedics, Genentech, Pfizer and Seattle Genetics. Parallel tracks were also organized addressing ADC discovery, development and optimization of chemistry, manufacturing and control (CMC) issues. Discovery and process scientists, regulatory experts (US Food and Drug Administration), academics and clinicians were present, including representatives from biotechnology firms (Concortis, CytomX Therapeutics, Glykos, Evonik, Igenica, Innate Pharma, Mersana Therapeutics, Polytherics, Quanta Biodesign, Redwood Bioscience, Sutro Biopharma, SynAffix), pharmaceutical companies (Amgen, Genmab, Johnson and Johnson, MedImmune, Novartis, Progenics, Takeda) and contract research or manufacturing organizations (Baxter, Bayer, BSP Pharmaceuticals, Fujifilm/Diosynth, Lonza, Pierre Fabre Contract Manufacturing, Piramal, SAFC, SafeBridge).
Subject(s)
Antibodies, Neoplasm/therapeutic use , Antineoplastic Agents/therapeutic use , Drug Approval , Drug Delivery Systems , Immunoconjugates/therapeutic use , Neoplasms/drug therapy , Congresses as Topic , HumansABSTRACT
Advances in antibody-drug conjugates (ADCs) will permit sensitive discrimination between healthy and cancer cells. Promising clinical results generated much hope that this targeted prodrug therapy will offer more effective treatment options to patients. Manufacturing such highly potent biopharmaceuticals presents a series of unique challenges. Some specific skills required for the process development and production of ADCs are discussed. In addition to the accuracy and reliability needed to handle these potent and costly materials, coworker safety and equipment cleaning are of particular importance. The ideas and concepts shared in this article are based on the experience that Lonza has gained in the ADC field since 2004.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents/therapeutic use , Chemistry, Pharmaceutical/methods , Immunoconjugates/therapeutic use , Antibodies, Monoclonal/chemistry , Antineoplastic Agents/chemistry , Clinical Trials as Topic , Humans , Immunoconjugates/chemistry , Immunotoxins/chemistry , Immunotoxins/therapeutic use , Neoplasms/drug therapy , Prodrugs/therapeutic useABSTRACT
Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies (mAbs) with the potency of cytotoxic molecules, thereby taking advantage of the best characteristics of both components. Along with the development of the mAbs and cytotoxins, the design of chemical linkers to covalently bind these building blocks is making rapid progress but remains challenging. Recent advances have resulted in linkers having increased stability in the bloodstream while allowing efficient payload release within the tumor cell.
