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European Biopharmaceutical Review

Novel TFF Capsule Evaluation

Antibody-drug conjugates (ADCs) are a promising class of cancer chemotherapeutics. These drugs consist of a tumour-specific monoclonal antibody (mAb) conjugated to a highly potent cytotoxic agent via a stable linker molecule. The attached cytotoxin presents a unique safety challenge for chemotherapeutic ADC manufacturing compared to traditional mAb production, particularly regarding operator exposure. To mitigate exposure risk, manufacturers are adopting single-use components in post-conjugation stages of ADC production. Specifically, single-use tangential flow filtration (TFF) systems enable the safe production of cytotoxic ADCs. In this study, the performance of a novel single-use TFF capsule was compared with a traditional, multi-use TFF cassette in an ADC process. The data demonstrated that the single-use TFF capsule delivered performance standards equivalent to a TFF cassette while providing superior ease of use. This novel capsule represents a new generation of single-use TFF devices to improve safety and ease of use.

ADCs represent a modern application of Paul Ehrlich’s magic bullet concept (1). A tumour-specific antibody attached to a cytotoxic drug selectively delivers a toxic agent to a specific cancerous cell type in the body, triggering its death. Therefore, ADCs combine the delivery and cancer-killing functions of a drug in a single molecule (2). ADC development and manufacturing is a booming area of commercial activity with more than 50 ongoing clinical trials and four validated drugs brought to market in 2000, 2011, 2013, and 2017 (3-6).

By nature, ADCs are complex entities, and less than 2% of the administered dose reaches the target. This low-targeting efficiency requires that ADCs contain a highly active pharmaceutical ingredient (HAPI) payload when they do reach their intended targets (7). HAPI occupational exposure limits for a single worker employed at eight hours a day for 40 hours a week must be less than one microgram per cubic metre (8-10). These low maximum exposure levels pose significant challenges during manufacturing. Furthermore, classical ADC processes involve the use of aqueous buffers and excipients prone to microbiological contamination and organic solvents (typically dimethyl sulfoxide [DMSO] and dimethylacetamide [DMAC]), all of which present additional health concerns.

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Marc Frederic is head of a process development lab for the Sanofi bio-organic team, who are dedicated to protein conjugates to support research programmes leading to commercial launch readiness. Marc is an experiment design expert and has a technical chemistry background.

Dr Eric Lacoste is head of the Sanofi bio-organic team. He is in charge of the supervision of process development for protein conjugates to support research programmes leading to commercial launch readiness. Eric is responsible for process transfer and overseeing current Good Manufacturing Practice (cGMP) manufacturing. He holds a PhD in organic chemistry.

Philippe Masson is a technician for the Sanofi bio-organic team and is an expert in chemical engineering.

Catherine Souder is head of a process development lab for the Sanofi bio-organic team. Catherine is also responsible for process transfer and overseeing cGMP manufacturing, and has a technical chemistry background.

Jonathan Steen is a principal engineer leading TFF Applications R&D for Merck. He holds a BS in chemical engineering, is a licensed professional engineer, and has over 20 years of experience developing tangential flow filtration solutions for biopharmaceutical applications.

Alexandre Laly holds a BS in biochemistry and an MS in biological engineering, specialising in pharmaceutical bioprocesses. Alexandre has worked at Merck Group since 2015 as a Technology Manager, specialising in filtration technologies covering Europe, the Middle East, and Africa.
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Marc Frederic
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Dr Eric Lacoste
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Philippe Masson
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Catherine Souder
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Jonathan Steen
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Alexandre Laly
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