Antibody therapeutics are one of the fastest growing classes of pharmaceuticals, with an annual US market over $20 billion, developed to treat a variety of diseases including cancer, auto-immune and infectious diseases. Most are currently administered as a single molecule to treat a single disease, however there is mounting evidence that cocktails of multiple antibodies, each with a unique binding specificity and protective mechanism, may improve clinical efficacy. Here, we review progress in the development of oligoclonal combinations of antibodies to treat disease, focusing on identification of synergistic antibodies. We then discuss the application of modern antibody engineering technologies to produce highly potent antibody preparations, including oligoclonal antibody cocktails and truly recombinant polyclonal antibodies. Specific examples illustrating the synergy conferred by multiple antibodies will be provided for diseases caused by botulinum toxin, cancer and immune thrombocytopenia. The bioprocessing and regulatory options for these preparations will be discussed.

中文翻译：

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回到未来：重组多克隆抗体疗法。

抗体疗法是增长最快的药物类别之一，每年在美国的市场超过 200 亿美元，用于治疗多种疾病，包括癌症、自身免疫性疾病和传染病。大多数目前作为单一分子给药以治疗单一疾病，但越来越多的证据表明，多种抗体的混合物，每种都具有独特的结合特异性和保护机制，可以提高临床疗效。在这里，我们回顾了用于治疗疾病的抗体寡克隆组合的开发进展，重点是识别协同抗体。然后我们讨论了现代抗体工程技术在生产高效抗体制剂中的应用，包括寡克隆抗体混合物和真正的重组多克隆抗体。将针对肉毒杆菌毒素、癌症和免疫性血小板减少症引起的疾病提供说明多种抗体赋予的协同作用的具体实例。将讨论这些制剂的生物加工和监管选择。