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Cerbios' Senior Scientist on Antibody Drug Conjugates

Lugano, March 20 2018

Interview published by courtesy of TeknoScienze Publisher

1. Which are the trends that will characterize the Antibody-Drug Conjugates (ADCs) sector?
ADCs are advanced chemotherapy treatments in which the cytotoxic payload targets the tumor cell by means of an antibody. The specificity and affinity of the antibody molecule combined is the key to the safe delivery of the toxic payload into the cell overexpressing a certain tumor -associated antigen at its surface.

The previous generation of ADC payloads (dominated by Auristatins and Maytansinoids) is now being superseded by new classes of toxins that are more potent than those currently available (with a potency in the picomolar range or lower) and will help to further reduce doses.

As a CDMO, Cerbios-Pharma SA (hereinafter “CERBIOS”) is already experiencing this change as it works with molecules that are becoming more potent every day. Significant new manufacturing challenges are associated with next-generation payloads and CDMOs need to be ready to provide suitable processing solutions. (...)

2.         People are talking about the “ADC Revolution”: what will the next-generation ADCs be like? What approaches will manufacturers have to adopt in terms of process and development?
One of the drawbacks of the monoclonal antibodies used to treat solid tumors is their poor tissue penetration and the consequent ineffective delivery of the cytotoxic payload. One way to overcome this problem is to reduce the size of the antibody. (…)

It is remarkable how, in ADCs, the two main components (payload and protein) generate significant increases in overall manufacturing costs, which is prompting CDMOs to develop a more efficient process, by switching the focus from the final product to the conjugation process. Consequently, the process development approach we are using follows the principles of Quality by Design (QbD) accompanied by Design of Experiments (DOE) and the implementation of Process Analytical Technologies that are now a regular part of good practices and have even been incorporated into current guidelines.

Finally, and consequently, supply chain integration could be an essential step towards further reducing manufacturing and development costs: a solution that CERBIOS makes available through the PROVEO® alliance, where protein scaffolds for the ADCs will need to be provided directly in conditions that are suitable for the conjugation step, including as the final step of the Fill-and-finish of the conjugate either in liquid or lyophilized form.

(...)

4. The production of highly potent toxins and their conjugation with proteins represents an example of “cross-contamination” between chemistry and biology. What are your thoughts on this, imagining a SWOT analysis within this production setting?
Yes, ADCs bring a unique kind of challenge, in that they are generated in a process that has chemical and biological requirements.  The strength of CERBIOS, lies precisely in the coexistence of these worlds: for 40 years it has housed under the same roof both a Chemical Division (for the production of folates, vitamin D derivatives and HPAI) and a Biological Division (for recombinant proteins and probiotics). At CERBIOS, ADCs mean applying both its expertise in the development and manufacturing of HPAIs and its experience and know how in the production and manipulation of recombinant proteins, on the same site in Lugano (a very unique setup).

The continuous growth of the ADCs currently in the development and early clinical phases, associated with the high added value of these products, represents an excellent opportunity for CERBIOS as a CDMO.

To read the full interview on Pharma Horizon, click here.

About Cerbios-Pharma SA

Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.

Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.

Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.
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