MDISprint: Accelerating Inhalation Innovation
MDISprint™
OzUK MDISprint represents an expedited pathway for the commercialization of your Metered Dose Inhaler (MDI) product. Leveraging a lean methodology, MDISprint systematically optimizes product development processes. This approach entails the concurrent execution of essential product Chemistry, Manufacturing, and Controls (CMC) and development modules with minimized interdependencies, resulting in a streamlined time-to-market. Significantly, OzUK has established strategic collaborations with key industry stakeholders, encompassing the meticulous selection and validation of critical components such as canisters, valves, actuators, and propellants, as well as providing comprehensive services ranging from commercial scale-up and Contract Development and Manufacturing Organization (CDMO) support to Contract Research Organization (CRO) engagement and Good Manufacturing Practice (GMP) manufacturing for clinical trials.
Our unique process
1. Target Product Profile Identification:
At the forefront of its methodology, OzUK MDISprint undertakes a meticulous process for identifying the target product profile. In the case of Abbreviated New Drug Applications (ANDA), this entails a rigorous screening of the innovator product using a range of proprietary methodologies. These methods assess key attributes that are crucial for the successful transfer to the generic product. Alternatively, for New Chemical Entities (NCE) or repurposed molecules, OzUK defines the pivotal attributes of the product and establishes a comprehensive commercial roadmap.
OzUK employs a suite of key methodologies, including physicochemical characterization of formulation components, establishment of related substance assays, and consideration of solubility, phase behavior, pH, dielectric constant, particle maturation, dissolution, and extensive Aerodynamic Particle Size Distribution (APSD) characterization. Notably, the expedited generation of a fast-track Target Product Profile (TPP) is facilitated by established componentry compatibility profiles. This enables OzUK to secure a formulation matrix swiftly, fostering the accelerated development of a finished product.
2. Formulation Development & Product Finalisation
In the formulation development phase, OzUK MDISprint's comprehensive methodology goes beyond the swift Target Product Profile (TPP) lock-in achieved in Phase 1. By incorporating both conventional and proprietary product development approaches early in the process, OzUK significantly reduces the need for numerous product iterations and variations in the later stages of development. The rapid data collection in Phase 1 enables informed decision-making, streamlining the development process, accelerating the timeline, and minimizing resource expenditure for a more cost-effective and efficient formulation pathway.
Moreover, OzUK places paramount importance on implementing International Council for Harmonisation (ICH) stability testing and Aerodynamic Particle Size Distribution (APSD) testing to optimize aerosol performance. This ensures consistent and efficient drug delivery, aligning with regulatory expectations and enhancing overall efficacy. Our methodology also addresses dose reproducibility, crucial for therapeutic efficacy and safety, and considers dose counter functionalities to accurately track doses. By integrating these elements, MDISprint delivers high-quality and optimized inhalation products that meet stringent regulatory requirements.
3. Formulation Development & Product Finalisation
MDISprint acknowledges the pivotal role of streamlined scale-up processes in manufacturing. The methodology proactively incorporates concurrent planning for scale-up considerations, identifying potential challenges and optimising manufacturing processes from early development stages. This proactive approach minimizes risks associated with scale-up, ensuring an efficient and cost-effective transition from laboratory-scale to commercial-scale production. OzUK's extensive experience in commercial MDI manufacturing includes aiding clients in establishing and commissioning MDI production lines, addressing scale-up and material handling considerations, managing pilot plants, handling HFA propellants, and overseeing the transfer and filling processes for both solution and suspension MDIs. As such, scale-up considerations are integral to the early phases of MDISprint, ensuring strategic implementation and planning.
4. Holistic Market Support and Collaborations
OzUK MDISprint goes beyond formulation and manufacturing, providing comprehensive support to the market through end-to-end services. This encompasses the selection and validation of key componentry, engagement with Contract Development and Manufacturing Organizations (CDMOs) for commercial scale manufacturing, and collaborative interactions with component, Active Pharmaceutical Ingredient (API), and propellant suppliers to secure high-quality raw materials.
Furthermore, MDISprint actively engages with Contract Research Organizations (CROs) to facilitate seamless clinical trials, ensuring efficient and reliable outcomes. The methodology also involves strategic partnerships with Good Manufacturing Practice (GMP) manufacturers for both early and later stages of clinical trial manufacturing. This multifaceted approach ensures that MDISprint clients benefit from a well-rounded and strategic engagement with industry stakeholders, positioning them for success in the dynamic and competitive pharmaceutical market.