For decades, the hallmark of medical treatment for cancer and hematological malignancies has been intravenous cytotoxic chemotherapy. These drugs target rapidly dividing cells, including cancer cells and certain normal tissues. As a result, many patients experience the classic toxicities of alopecia, gastrointestinal symptoms, and myelosuppression.
But how we treat these diseases has changed dramatically in the past decades. While traditional cytotoxic chemotherapy remains the treatment of choice, targeted therapies are now a major component in our arsenal in the war on cancer. These novel targeted anti-cancer drug therapies have been designed to block the growth and spread of certain cancers by interfering with specific molecules – called molecular targets - that are involved in the growth, progression, and spread of cancer and hematological malignancies.
They have become a component of anti-cancer therapies for many common malignancies, including breast, colorectal, lung, and pancreatic cancers, as well as lymphoma, leukemia, and multiple myeloma.
The mechanisms of action and toxicities of targeted therapies - the right drug for the right patient, at the right time - differs from those of traditional cytotoxic chemotherapy.
As a result, targeted therapies are generally better tolerated than traditional chemotherapy. Among these targeted drugs are antibody-drug conjugates or ADCs.
While today only a small number of antibody-drug conjugates have obtained market authorization, a large number of these targeted therapies are in clinical development.
Antibody-drug Conjugates are part of a new wave of targeted antibody-based products at the cutting edge of oncology and hematology. These hybrid molecules consist of a tumor antigen-specific antibody coupled to a chemotherapeutic small molecule.
Antibody-drug Conjugates combine the cell targeting capability of monoclonal antibodies with the cell killing ability of highly potent cytotoxic drugs. Through targeted delivery of highly potent cytotoxins, antibody-drug conjugates exhibit improved therapeutic index and enhanced efficacy relative to traditional chemotherapies and monoclonal antibody therapies.
The manufacturing of these highly potent cytotoxic antibody-drug conjugates presents a series of unique challenges, requiring specific skills, accuracy and reliability.
During the Essential Protein Engineering Summit – PEGS - held April 25 – 29, 2016, in Boston, Massachusetts, we sat down with Richard Denk, an expert on containment and hygienic design and one of the authors of the Containment Handbook, published by the International Society for Pharmaceutical Engineering.
Richard Denk is the head of the Containment Group of SKAN AG in Switzerland. He has spent nearly 20 years in developing global standards for highly active and highly hazardous substances. Denk addresses the importance of awareness of an acceptable Occupational Exposure Limit or OEL when manufacturing antibody-drug conjugates. Given the potency of the cytotoxins in antibody-drug conjugates, he also discusses the need for specific containment solutions during the manufacturing of these novel anti-cancer agents.
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