Your process has a lot of moving parts. API synthesis, drug product formulation, fill and finish, product packaging, testing and release all must be carefully orchestrated - even while you’re racing against the clock. We relish this challenge and wouldn’t want it any other way! Come tell us about your unique challenge and our team will find a solution we are sure you’ll love.
Throw anything at us. We can take it. Our teams have transferred and developed processes for PET & SPECT imaging agents, alpha and beta radiotherapeutics, small molecules and biologics.
Here are some of the things that we can do for you:
Quality is our starting point at the CPDC. Whether we are conducting a tech-transfer or designing a process from scratch, CPDC builds quality into your program from its inception. CPDC’s seasoned quality assurance (QA) group works closely with our clients to understand their unique needs and ensures that all our programs are conducted in accordance to international Good Manufacturing Practices (GMPs).
Bring us your process and we will optimize and validate it within our facility. Our process scientists are experienced with many automated platforms, and our analytical scientists are highly skilled and equipped for almost every chemical, biological and microbiological technique. Whether you need a single site to produce an I-131 agent, or want to expand to our Canadian cyclotron and cGMP production network for an F-18 labelled product, or even need production of an entirely novel radiotherapeutic, we can find a solution that’s right for you.
Our process scientists are the best in the world and they have done some truly amazing things. We can increase yields, make synthesis and purifications simpler and more robust, and automate the whole process from front to back. Any isotope, any scale, any vector — we can create a remarkable solution
We’ve assembled an incredible team of analytical scientists. Our team can develop methods to find that radiopharmaceutical needle in the excipient haystack. HPLC, GC, MS or otherwise, we have the tools and equipment to develop a method from the ground up, integrating all the bioanalytical and radiometric techniques needed for your drug.
Chances are that your drug needs to be sterile. We take this very seriously and our teams have created rigorous validation programs to control not only the process and analytical methods but also for all associated engineering systems and controls. Our in-house microbiology staff works closely with our production team to perform bioburden assessment, media fill validation, and instate a whole host of environmental controls throughout the process. With all this attention to detail, you can feel confident that your drug is being made to the highest standards within our FDA and Health Canada inspected facilities.
We’ve made you a drug – what’s next? CPDC’s regulatory team can make your CTA or IND submission a snap. They can assemble the supporting CMC package for Health Canada or the FDA and provide expert input on how to shape your submission and interface with the regulator. Whether you need us to compose the filing or setup and manage a pre-IND meeting with the FDA our team can help.
We regularly deliver throughout North America and Europe. Wherever in the world you need to go, our teams will work with you to develop the supply-chain and logistics to ensure your product arrives on time, every time. We operate around the clock and will design our schedule to optimize the utility of the isotope and losses due to decay and deliver it to your hospital or clinic when requested. By air or by ground we can find a solution that fits your needs for clinical trials and commercial supply.