This week, SpeakPharma speaks to Aleš Šima, Head of Business Development Department at ., a subsidiary of the German pharmaceutical company — Gesellschaft für klinische Spezialpräparate mbH.
Oncomed is a fill and finish CDMO located in Brno, Czech Republic.
This flexible CDMO specializes in high potent injectables, complex formulations in clinical and commercial scale, including chemical APIs and biomolecules.
In this interview, Šima tells us how Oncomed strives to become a globally recognized, top CDMO over the next five years by adopting a strategy that looks at meeting the various needs of its customers.
Cytotoxic drugs or cytostatics are drugs used to destroy cancer cells. Cytotoxic drugs inhibit cell division and in this way they cause cancer cells to die.
Cytotoxic drugs are widely used in cancer therapy and often several types of cytotoxic drugs are used in combination as they have different kinds of impact.
Over time, new formulations of cytostatic drugs are becoming more complex. For instance, some cytostatic drugs are not soluble in water, some are sensitive to temperature, light or oxygen, and some have a low process time (holding time) of bulk solution.
With regard to small molecules, there are several complex products in different stages of their lifecycle at Oncomed. We are ISO 18001 certified, and this confirms our capability to handle not only high-potent/cyto molecules but also organic solvents.
We have several organic solvent-based products which are freeze-dried. Handling and freeze-drying of organic solvents is our specialty and also our main competitive advantage. For example, some of the organic solvents are highly explosive and we have the processes in place to assure safety of operators and of the product itself. Our freeze dryer has a solvent separator and we also have the capability of switching the cooling medium within freeze-drying to liquid nitrogen. By this technology we are able to achieve a temperature up to -90°C on condenser within the drying phase.
With regards to large molecules, we currently transform our long history and experience of aseptic fill and finish into this space and are entering the market as a fill and finish provider of antibody drug conjugates (ADCs) and other biomolecules. As the ADC market is witnessing rapid growth, we are continuously broadening our expertise in this field to become the world’s number one fill and finish manufacturer of ADCs.
Our manufacturing facility is state-of-the-art and we follow the latest trends. We are flexible and open to adopting processes based on the customer’s request. We also cater to the project-specific requirements of our customers.
We always create a team that best suits the project requirements. For instance, our project team consists of project managers, pharmaceutical development specialists, analytical development specialists and QA specialists. Moreover, we always involve an engineering specialist at some point during a project. If required, we also get other specific team member(s). Customer satisfaction and establishment of strategic and long-term cooperation is our main goal.
— What kind of support are you giving your clients along the lifecycle of the products?Scalability is our big advantage. We provide support at each stage of the lifecycle of a product. We can develop, scale-up and tech transfer the projects using the QbD (Quality by Design) approach, which eliminates the risks of failure of a project by following a proper risk assessment strategy.
We have invested in different sizes of equipment that enables scalability. Recently, we implemented a flexible, single-use system technology to accelerate formulation process development. Therefore, we offer two options — a stainless-steel concept which includes cleaning validation and the single-use system technology. Both concepts have their pros and cons and we are always open to discussing the customer needs to propose the right concept of processing their molecule.
Currently, we operate two commercial lines at our site in Brno. Line 1 is based on the standard clean room concept, but the set-up processes allow us to operate the line according to the latest, most stringent regulatory norms. On this line, we have two freeze-dryers of 17 square meters each.
Our second line is the state-of-the-art isolator technology equipped with one freeze-dryer of 12 square meter. This freeze-dryer has a dual-cooling system, which means we can switch to cooling through liquid nitrogen.
Both lines are regularly validated by media fill (the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production).
We have standard procedures in place and are continuously optimizing the processes on both lines.
Oncomed is about to become the top CDMO, providing end-to-end solutions to current and new strategic customers. Our multi-year planning includes a new, state-of-the-art production line with significant freeze-drying capacity in our current facility in Brno.
We are open to various business models, including co-development, and are growing in the large molecules space.
We understand our target audience’s needs and adapt our service offerings accordingly. We also comply with our brand promises and support our customers, thereby establishing long-term relationships.