A CDMO’s Perspective on Outsourcing Challenges for ADCs–Part 1

In an interview with Pharmaceutical Technology®, Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, discusses three challenges he sees with bringing new antibody-drug conjugates (ADCs) to market. The first challenge is tied in with the overall dynamic of innovation as much of this innovation is coming for small biotech firms, and those companies are not equipped with the internal capacity to produce product. Secondly, there is also a lack of expertise for the industrialization and scale up of ADC manufacturing, and thirdly is the complexity of the supply chain, Morello enumerates.

“[These are] the three main challenges that an ADC developer has to face and has to overcome to make clinical supply, or to make commercial supply,” Morello says. “And this is where a CDMO [contract development and manufacturing organization] [such as] Lonza brings in a lot of benefit.

The science of ADC manufacturing has evolved much over the past 20 years, Morello also emphasizes. There has been much improvement in the technology for making the monoclonal antibody (mAb) component (i.e., carrier) as well as in the linker technology. Therefore, Morello explains, “If you want to go fast, you need to make sure that you have the expertise to take care of your drug and the complexity of the manufacturing as well the experience to scale up and go through the different regulatory paths.”

Morello also points out that an ADC developer is not obliged to build in-house capacity, “because then you can allocate [that] money on the clinical development, [which is where] you will create and validate your concept associated to the development of the drug. So, clearly, when you look at the overall portfolio, 70 to 80% of the ADC portfolio is outsourcing.”

Click above for the full interview.

Click here for part 2 of this interview.

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About the speaker

Christian Morello, Vice President and Head, Bioconjugates Business Unit, Lonza

Christian Morello is vice president and head of the Bioconjugates Business Unit at Lonza. He is responsible for establishing and driving strategy of the business unit developing bioconjugates/antibody-drug conjugate (ADC) manufacturing services for Lonza’s customers worldwide. Prior to joining Lonza, Morello was the head of Global Project Management at Sanofi where he oversaw the development portfolio execution. He is a biochemical engineer and has over 28 years of experience in drug development from discovery to registration, planning, manufacturing, and programs management.