CDMO and CMC services
Targeted radiopharmaceutical therapies have shown great potential as an effective and highly selective way to treat solid cancers.
Using tumor-targeting small molecules, peptides or biologics to deliver a cytotoxic payload induces powerful DNA damage in tumor cells, while limiting damage to normal, healthy tissue.
When you are looking for fast and efficient development, evaluation, and clinical translation of targeted radiopharmaceutical therapies you need a partner with extensive scientific, regulatory and operational expertise.
Minerva offers a comprehensive range of CMC services for radiopharmaceutical and theranostic development.
At Minerva Imaging, we specialize in helping pharmaceutical companies fulfill the promise of nuclear medicine by partnering to develop comprehensive tailored solutions in close cooperation with them.
Building on a very successful track record of more than twelve years offering pre-clinical services to more than 100 global pharma and biotech we are expanding our services into CDMO. With this expansion we provide a complete, integrated service offering, covering all the steps from early preclinical target validation to clinical cGMP supplies for First-in-Human studies and beyond.
Why Choose Us for CDMO and CMC services?
- World-class Expertise: With more than twelve years of experience in the field of radiopharmaceuticals, our teams of skilled professionals possess the expertise required for radiopharmaceutical development. We understand the intricacies and complexities involved in bringing radiopharmaceuticals to market, and we are here to guide you through every step of the process.
- Tailored Solutions: We recognize that each radiopharmaceutical project is unique, requiring a customized approach. Our dedicated teams will work closely with you to understand your specific requirements and goals, allowing us to design a CMC development strategy that aligns with your vision and delivers all the required outcomes.
- Cutting-Edge Technology: Our commitment to staying at the forefront of scientific advancements means we utilize the latest technologies and methodologies in CMC development. From synthesis and purification to formulation and packaging, we employ the required tools and SOPs to ensure the highest quality and deliverables.
- Cross-functional teams: We ensure a fast and smooth transfer of protocols and compounds from our preclinical projects to cGMP-compliant procedures in our CDMO facility, by mirroring the setup of our teams and laboratories in the CRO and CDMO facilities. To learn more about our preclinical services, please follow this link.
- Regulatory Compliance: Navigating the regulatory landscape can be challenging, but our team has a deep understanding of regulatory requirements for radiopharmaceutical development. We will assist you in preparing the necessary documentation, facilitating smooth interactions with regulatory agencies, and ensuring compliance with industry standards.
- Quality Assurance: We are committed to delivering excellence in every aspect of our services. Our thorough quality assurance processes ensure that your radiopharmaceutical development project adheres to the highest standards of quality, safety, and efficacy. We are dedicated to helping you bring safe and effective radiopharmaceuticals to patients in need.
- Collaborative Approach: We believe in building strong partnerships with our clients. Throughout the CMC development journey, we foster open communication, collaboration, and transparency. Your input and insights are invaluable to us, and we work together to achieve successful outcomes.
Whether you are a pharmaceutical company or a biotech our CMC development services for radiopharmaceuticals will significantly advance your project and bring you closer to transforming patient care.
Global distribution under GDP
Broad clinical distribution under GDP is key to successful application of the radiotherapeutic compounds by our partners.
Our state-of-the-art CDMO facilities are based close to Copenhagen, Denmark, with easy access to Copenhagen Airport, the largest international airport in the Nordic Countries.
Depending on the application and half-life of the respective radioisotope, we are able to provide a stable supply chain across Europe and North America within a clinically relevant timeline.
We have extensive experience with a wide selection of diagnostic and therapeutic radioisotopes. Our range of available radioisotopes is continuously expanding, and we are happy to discuss the characterisation of novel radioisotopes for your diagnostic and therapeutic applications.