Merck Launches Single-Use Reactor Designed to Accelerate Antibody Drug Conjugate Manufacturing

• First scalable single-use mixer specifically designed for ADC manufacturing
• Increases efficiency by 70% compared to stainless steel or glass manufacturing methods
• Utilizes Ultimus^® Film for superior leak resistance

Darmstadt, Germany, September 10, 2024 – Merck, a leading science and technology company, launched the first single-use reactor specifically designed to manufacture antibody drug conjugates (ADCs). ADCs are a rapidly emerging class of therapeutic agents that can target and selectively kill tumor cells, while protecting healthy ones. The Mobius^® ADC Reactor is tailored precisely to meet the unique requirements for linking the necessary components. It enables biopharmaceutical companies to produce their critical therapies faster and safer.

“We have been providing single-use solutions for flexible biopharmaceutical manufacturing for more than 15 years. Drawing on this extensive experience, we are now ready to accelerate the production of antibody-drug conjugates," said Sebastian Arana, Head of Process Solutions for the Life Science business of Merck. "The launch of the Mobius^® ADC Reactor will support our customers to bring much-needed therapies to a global population.”

Current ADC production methods use stainless steel or glass reactors which require labor-intensive and costly cleaning procedures. Single-use technology costs less, reduces risk, and is more flexible and faster than these traditional methods. However, the adoption of this technology in ADC manufacturing has been limited due to the unique chemical compatibility and quality requirements. The Mobius^® ADC Reactor changes this by offering faster turnaround times and fewer cross-contamination risks, all while maintaining high product quality. Performance improvements include elimination of potent liquid waste and a 70% increase in efficiency. Additionally, the new reactor’s single-use assemblies are made of Ultimus^® Film technology, providing enhanced bag strength, improved durability, and leak resistance.

Merck offers a wide range of solutions tailored to the specific requirements of ADC manufacturing. For purification processes, these include the Mobius^® single-use systems for chromatography and tangential flow filtration (TFF), particularly used in closed-mode operations, paired with consumables such as the Pellicon^® capsule. Merck also offers contract development and manufacturing organization (CDMO) and testing services for ADCs and high-potent active pharmaceutical ingredients (HPAPIs.)

Antibody Drug Conjugates

Antibody drug conjugates (ADCs) are medicines that target specific cells in the body, such as cancer cells. They work by combining a monoclonal antibody (mAb), which acts like a guide, with a drug. The mAb finds and attaches itself to certain antigens found on the surface of targeted cells. This allows the drug to be delivered directly to the targeted cell, resulting in cell death. Damage to surrounding healthy cells is minimized. This targeted approach means fewer side effects compared to other treatments. ADCs therefore offer a way to treat diseases more precisely and safely.

Due to their promise for patients, ADCs have experienced incredible growth over the years, with 13 ADCs currently approved by the FDA, eight of which have been approved since 2019¹.

¹ https://broadpharm.com/blog/ADC-Approval-up-to-2023