Patient-Centric CDMO Services – Expertise in Bioprocess Tech Transfers

With over 14 years of experience, our integrated solutions help pharmaceutical companies bring their innovations to the market, always keeping the patient at the center of everything we do. By driving rapid development, cost-effectiveness, and compliance with the highest global standards, we aim to deliver better healthcare solutions to those who need them most. Among our many services, our expertise in Tech Transfers plays a vital role in bringing these therapies to patients worldwide, enabling a smooth transition from lab-scale development to full commercial production.

What Sets mAbxience Apart in Bioprocess Tech Transfers

At mAbxience, our development and Tech Transfer services are designed to help pharmaceutical innovators bring complex biologics from research to the hands of patients. By ensuring a seamless transition into commercial-scale production, we enable faster access to groundbreaking therapies. With two state-of-the-art facilities in Spain and Argentina, equipped with cutting-edge single-use technologies for mammalian production, we can manufacture monoclonal antibodies (mAbs) and the most sophisticated biologics like bispecific antibodies and fusion proteins. Our Tech Transfers prioritize speed, flexibility, cost efficiencies, ensuring that life-saving treatments are delivered to patients without delay.

Our dual-site strategy—both facilities with identical configuration and operating under the same quality policies—allows us to offer an added layer of security and supply continuity for our clients, but more importantly, it ensures uninterrupted access to critical treatments for patients with fast adaptation to varying supply demands. Whether scaling from a 200L to a 4,000L single-use bioreactor (SUB), our facilities are built to handle varying project needs, from early-phase clinical trials to full-scale commercial production, all with the ultimate goal of improving patient outcomes.

End-to-End Expertise: Ensuring Seamless Supply for Patients

The quality of our Tech Transfer process is its comprehensive scope. Our CDMO services cover the entire production journey, from cell line development through upstream and downstream processing. This holistic approach ensures that every stage in the production of our partners’ medicines is carefully optimized for efficiency, regulatory compliance, and quality—because when it comes to patients’ health, there can be no compromise on safety or quality.

During Tech Transfers, our dedicated team of experts works closely with our customers to ensure that the transferred process meets current regulatory requirements in the target territories. This collaboration ensures that treatments reach patients sooner while maintaining the highest standards. By keeping close and constant communication and providing full transparency, we mitigate risks and resolve any technical challenges swiftly, ensuring patients can rely on receiving their medicines on time.

One of our key technical advantages is our use of single-use bioreactor systems. These systems allow us to scale up production efficiently, reducing contamination risk and ensuring that changes in production needs are addressed quickly. This flexibility has made mAbxience a trusted partner for companies seeking to expedite their time to market in multiple countries.

Ensuring Speed and Quality in Every Transfer, for Every Patient

At mAbxience, speed and quality go hand in hand, especially when patients’ lives depend on it. Our streamlined Tech Transfer processes, combined with our extensive regulatory expertise, enable us to accelerate development timelines while ensuring regulatory compliance. Our fast-track 12-month program helps our clients meet key milestones, such as IND filings or clinical trial applications (CTA), without compromising on quality or patient safety.

Our dedicated Regulatory and Quality teams play a crucial role in the Tech Transfer process, ensuring that all operations adhere to the stringent standards of global regulatory agencies like the FDA, EMA, and others. With over 30% of our workforce dedicated to regulatory affairs and quality, mAbxience provides an unmatched level of expertise in navigating the complex global regulatory landscape, ensuring that every treatment delivered is safe and effective for the patients who rely on them.

Your Patient-Centric Partner for Flexible and Reliable Tech Transfers

In today’s competitive biopharmaceutical landscape, having a reliable and flexible CDMO partner is critical to success, but more importantly, it is essential for ensuring that patients across the globe receive the treatments they need, when they need them. At mAbxience, our tailored Tech Transfer services help pharmaceutical companies streamline their biologics supply chain, shorten time-to-market, and maintain the highest standards of quality and patient safety. By leveraging our expertise, innovative technologies, and dual-site manufacturing capabilities, we deliver solutions that meet the unique needs of every biopharma partner and every patient.

Whether you are scaling up a novel therapeutic or bringing a biosimilar to market, mAbxience is committed to being your trusted partner in biologics development and production—because we understand that behind every project, there is a patient waiting for a cure. Contact us today to learn how we can support your next project with our world-class Tech Transfer services: www.mabxience.com