The Immedica way of managing manufacturing
Where are Immedica’s products manufactured?
Immedica does not perform manufacturing internally, meaning that we do not own any factories or labs. Rather, we work closely with a network of Contract Manufacturing Organizations (CMOs) to manufacture our products. This brings many benefits for us since we can choose CMO based on the expertise in the technology needed for each specific product. Immedica’s portfolio consists of both small and large molecules (‘biologics’) and a range of different formulations; oral solid dose, oral liquids, injectables to mention a few. Also, with a portfolio of rare disease and niche products, volumes are typically relatively small in number of doses per year. The products are extremely important to the patients and make a huge difference in their lives. By cooperating with different CMOs, we can make sure that we provide medicines to the patients in a cost-efficient way without heavy investments in manufacturing assets.
How are manufacturers selected?
Since Immedica does not have any internal R&D organization, our drug portfolio is based on acquisitions or partnerships with other pharma companies. In many cases, we purchase the right to a product for our primary territories, Europe and MENA, and our partners maintain the rights for the product in other territories. This means that we can have the opportunity to consolidate manufacturing of the product to one location to gain benefits of scale. For example, we can use the same CMOs as our partner for manufacturing of the Drug Substance and Drug Product, whereas we work with local CMOs for secondary packing to provide market specific packs in alignment with local market requirements in our territories. In other cases, Immedica purchases products from a company that does not intend to continue manufacturing this product. In these cases, Immedica evaluate the individual products and their needs and identify CMOs that will be the best fit for the products.
Setting up manufacturing of a new product
When Immedica selects a new CMO, either to take on manufacturing that has previously been carried out by someone else, or to start to manufacture a novel product that has never before been manufactured in industrial scale, we perform a Technology Transfer to the CMO. This involves transfer of know-how and documentation (“the recipe”) from the previous manufacturer, or the R&D organization that has developed the product, to the new CMO that Immedica has carefully chosen. In this process, Immedica is facilitating and project managing the transfer between the previous and the new manufacturer. This includes validating the manufacturing and quality control processes at the CMO to ensure that the CMO is capable of manufacturing the product in a repeatable way with a consistent outcome that meets the standards for pharmaceutical products. We also engage with the health authorities in the territories where we will offer the product (e.g. the European Medicines Agency) and register the details of our manufacturing set-up. To do this, Immedica has a cross-functional team of experienced specialists within Supply Chain, Quality Assurance, Regulatory Affairs and Manufacturing that works closely with the experts at the CMO. Being a small organization, but with very experienced and committed team members, Immedica is recognized by our partners as being both competent and agile, enabling projects to progress efficiently.
Managing outsourced manufacturing
Once a technology transfer project is completed, the CMO is ready to start manufacturing the product. However, the cross-functional Immedica team continues to work closely with the CMO to monitor that the high-quality standards are met, that any changes in requirements or regulations are implemented properly, that the manufacturing rate is adjusted when the product demand changes etc. Through a close collaboration with our CMOs, we continue to work every day to ensure that our patients get the products they need!