Article >> Pharma Horizons V2/'18 >> Parenteral Drug Manufacturing Panel Discussion > Jason Bertola

May 03, 2018

How the Shift to Complex, Targeted Cancer Drugs is ReShaping Parenteral Drug Manufacturing

by Jason Bertola, Director, Global Highly Potent & Onology Platform, CPI

Over the past 20 years, Oncology Drug Product development has experienced signifi cant change. Mass-market cytotoxic agents have given way to more complex, potent, and targeted therapies that serve smaller patient populations. This shift, although good for the patient, has put strains on parenteral drug manufacturing plants. Manufacturers that used to dedicate signifi cant production capacity to products like Paclitaxel, now face the logistical and technical complexity of fi lling capacity with small volume programs for multiple drugs.
The pace of change is illustrated by data from the industry pipeline. Cytotoxic drugs now account for 8% of the cancer pipeline, down from 15% in 2006 (1). Over the same period, targeted biologics’ share of the pipeline rose from 21% to 43%. These pipeline changes have reshaped the activities of the companies that manufacture injectable oncology drug products.
Production in the targeted therapy era
The production workfl ow of modern drugs is more challenging than the dissolve, fi lter, fi ll, cap & clamp, and ship process. Now manufacturers deal with complex drugs, and by extension, more challenging formulations. For example, liposomal formulations and antibody drug conjugates are more complex to manufacture than traditional chemotherapeutics.

Targeted therapies act on specific molecular targets associated with cancer. As such, they do not provide benefi ts to all patients. Ultimately, this also affects contract manufacturers by reducing the volumes their customers require. Low volumes and complexity affect the economics of manufacturing.

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