The transformative journey of eXmoor Pharma has reached a pivotal moment with the recent acquisition of a Manufacturing and Import Authorization for Investigational Medicinal Products (MIA(IMP)) license from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This milestone signifies that eXmoor, a company specializing in cell and gene therapy manufacturing services, is now authorized to manufacture GMP-grade cell and gene therapy materials for clinical trials. The license underscores eXmoor’s transition from a consultancy firm into a Contract Development and Manufacturing Organization (CDMO), poised to make substantial impacts within the biopharmaceutical industry.
Steps to Achieving MIA(IMP) License
Obtaining the MIA(IMP) license was no small feat for eXmoor Pharma, and it followed an exhaustive inspection by the MHRA of eXmoor’s Cell & Gene Therapy Centre in Bristol. This state-of-the-art facility symbolizes years of hard work and dedication, encapsulating eXmoor’s commitment to advancing cell and gene therapies. The successful inspection and subsequent licensing signify a major milestone in the company’s two-decade history, culminated through rigorous standards and adherence to stringent regulatory requirements.
The license validates the capabilities of the Cell & Gene Therapy Centre, designed to be a versatile and scalable manufacturing hub. Over a two-year period, the facility was meticulously engineered to support a variety of cell and gene therapy modalities. This meticulously planned center is now geared towards optimizing and scaling up multiple therapeutic processes, thereby strengthening eXmoor’s foothold in the industry. The facility not only demonstrates eXmoor’s technical prowess but also solidifies its reputation within the highly competitive biopharmaceutical sector.
Facility Features and Capabilities
eXmoor’s Cell & Gene Therapy Centre boasts a range of integrated process development and analytical laboratories, making it one of the UK’s premier locations for advanced therapies manufacturing. The facility includes four GMP clean rooms and specialized fill/finish capabilities. Flexibility is a key attribute of the center, allowing for the manufacture of various therapeutic materials, including cell therapies, RNA therapies, and viral vectors. The facility’s capacity is considerable, featuring up to 2 x 200-liter bioreactors and several autologous cell therapy stations per suite, thereby facilitating scale-up and optimization of complex manufacturing processes.
These advanced features enable eXmoor to offer a comprehensive suite of development, manufacturing, and consulting services. By providing support to cell and gene therapy developers from the research stages to market readiness, the facility operates as a cornerstone for clients aiming to bring innovative therapies to patients swiftly and efficiently. The strategic design and multiple capabilities of the center ensure that eXmoor is well-equipped to address the diverse needs of its clients, establishing itself as a key player in the cell and gene therapy industry.
Commitment to Sustainability
Sustainability is a core principle embedded in the design and operation of eXmoor’s Cell & Gene Therapy Centre. Operating on solar power and heat pumps, the facility stands as a cutting-edge, zero-carbon establishment. This commitment to environmental responsibility aligns with global trends towards sustainable practices in biopharmaceutical manufacturing. The green infrastructure not only reduces the facility’s carbon footprint but also exemplifies eXmoor’s dedication to eco-friendly ingenuity and long-term environmental stewardship.
The sustainable design elements ensure that the center runs efficiently without compromising on its advanced technological capabilities. Such measures reinforce eXmoor’s position as a forward-thinking leader in the cell and gene therapy space. By prioritizing sustainability, eXmoor is contributing to a more environmentally conscious future for the biopharmaceutical industry, setting new standards for responsible manufacturing practices.
Strategic Vision for Growth
Angela Osborne, CEO of eXmoor Pharma, regards the acquisition of the MIA(IMP) license as the beginning of a new growth phase for the company. By becoming a CDMO, eXmoor extends its offerings to encompass a comprehensive set of services that cater to cell and gene therapy developers. These include everything from initial research to large-scale manufacturing, illustrating eXmoor’s holistic approach to supporting its clients. The company’s strategic vision and expanded capabilities underscore its commitment to driving innovation and supporting the entire lifecycle of therapy development.
As the company looks to the future, plans are in place to expand GMP operations to both pivotal and commercial scales. The design of the Cell & Gene Therapy Centre allows for rapid and seamless increases in cleanroom capacity, demonstrating eXmoor’s strategic foresight in scalability. This proactive approach ensures that as demand in the biopharmaceutical industry grows, eXmoor is prepared to meet client needs without delay. Such strategic foresight highlights eXmoor’s readiness to adapt and grow in response to industry demands.
Leadership and Market Readiness
eXmoor Pharma has recently hit a major milestone by securing a Manufacturing and Import Authorization for Investigational Medicinal Products (MIA(IMP)) license from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This significant achievement allows eXmoor to manufacture GMP-grade cell and gene therapy materials for use in clinical trials. Originally a consultancy firm, eXmoor has successfully transitioned into a Contract Development and Manufacturing Organization (CDMO). Specializing in cell and gene therapy, eXmoor is now well-positioned to have a profound impact on the biopharmaceutical industry. The license from the MHRA underscores this transformation, validating eXmoor’s capabilities and setting the stage for future advancements. With this authorization, eXmoor can provide end-to-end services, from the development phase to clinical trials, cementing its role as a key player in the field. This development marks eXmoor’s evolution and highlights its commitment to contributing significantly to the advancement of medical therapies.
