Industry Perspectives are designed to help readers connect the dots among the various disciplines that make up the life sciences industry, with authoritative updates on issues related to basic research and production of Antibody-drug Conjugates.
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Successful Strategies in the Development and Technology Transfer of Antibody-Drug Conjugates
May 2, 2014 | Cynthia Wooge
Received April 24, 2014 | Accepted May 1, 2014 | Published online May 2, 2014
Effective introduction of a monoclonal antibody or antibody-drug conjugate into clinical trials and final commercialization requires a defined path toward an efficient, robust manufacturing process with suitable quality parameters. In this process, efficient technology transfer between the drug-developing technology originator and an approved and authorized third party or parties is crucial. In this article, Cynthia Wooge, Ph.D., discusses the requirements of a properly designed technology transfer process and how to ensure a successful transfer and reproducible conjugation process with solid analytics, appropriate engineering design, process (quality) controls and quality assurance. She emphasizes the need to understand which details are critical and how they get effectively communicated between the various parties involved in the transfer process.
Making Hot ADCs
March 7, 2014 | Sean L. Kitson, Thomas Moody, David Speed and William Waters
Received February 27, 2014; Accepted March 6, 2014; Published online March 7, 2014
Guided by a specific monoclonal antibody (mAb), antibody drug conjugates or ADC are a new, emerging, class of drugs able to deliver a drug payload directly to an intended target. This approach has recently been boosted by the U.S. Food and Drug Administration approval of brentuximab vedotin (Adcetris®; Seattle Genetics) to treat Hodgkin’s lymphoma and ado-trastuzumab emtansine (Kadcyla®; Genentech) for metastatic breast cancer. These new biotherapeutic drugs will bring many regulatory issues to the forefront regarding the ADME (Absorption, Distribution, Metabolism and Excretion) profile of each ADC. In this article, the authors discuss this and other important accepts of antibody-drug conjugates..
Considerations for Safe and Effective Manufacturing of Antibody-drug Conjugates (Update)
June 21, 2013 | Thomas Rohrer, Senior Director of ADC and Biochemical Technology at Lonza
Received May 31 2013; Accepted June 18, 2013; Published online June 21, 2013
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.