THOMAS ROHRER
Lonza Inc. 90 Boroline Road, Allendale, NJ 07401, USA

Abstract

Antibody drug conjugates are an emerging class of biotherapeutics which require unique supporting infrastructure to meet bio/ pharmaceutical industry standards for safe, effective and reliable manufacturing. These highly potent biopharmaceuticals present a series of unique manufacturing challenges driven by their potency and raw material supply chain. Facility design must take into consideration these manufacturing challenges to insure employee safety and robust process performance. The concepts addressed in this article convey the experience gained by Lonza during our years working with this class of biotherapeutics.

INTRODUCTION

Oncologists have dreamed of harnessing the target specificity of monoclonal antibodies to deliver cytotoxic drugs to the site of tumors for as long as monoclonal antibodies have existed. This approach would reduce undesirable side effects associated with traditional systemic administration of chemotherapeutic agents which does not differentiate between healthy and diseased tissue and often limits the therapeutic efficacy and potency of small molecule drugs (1). In the intervening three decades since the concept was explored two ADC have been approved with the first approved ADC gentuzumab ozogamcin ( Mylotarg^®) being voluntarily withdrawn from the US market in 2010 due to post market evidence of lack of efficiency, as well as unacceptable toxicity. A new study presented at the American Society of Hematology (2011) suggest Mylotarg along with chemotherapy, helped prolong the lives of patients just diagnosed with acute myeloid leukemia compared to chemotheraphy alone which may lead to a second chance for the drug.
In August of last year, the FDA announced it granted accelerated approval to brentuximab vedotin (Adcetris ^... ...