Dry powder inhalation (DPI) drug products are rightfully developed for patients with efficacy and safety in mind. However, as products move forward in the drug development process to clinical development, the ability to efficiently manufacture these products becomes critical in order to determine if a process is commercially feasible.
Whether a DPI product can be manufactured at scale is dependent upon chemical and physical properties of the powder. However, if the filling process is evaluated after the formula has been established, filling process risk can be introduced and in some cases, a robust process may not be able to be achieved.
In this webinar, DPI product formulation characteristics, including rheology, density and cohesiveness, will be examined as sources of potential process risk and a case study will demonstrate the impact drug product characteristics can have on processing.
Strategies for mitigating process risk will be presented to avoid revisiting formulation development and the resulting delays in getting DPI products to market.
Justin Lacombe, PhD, Vice President, Operations, Experic
With extensive experience on the client side, Justin Lacombe leads our operations team to proactively partner with our clients, offering more than just a manufacturing space. With a focus on scale-up and process development, he has managed projects for the manufacture of clinical trial materials, combining small-volume powder dosing technology, primary packaging development and formulation optimization.
In previous roles, Lacombe has been deeply involved in the development of inhaled pharmaceutical products, initially on meter dose inhalers at Catalent Pharma Solutions, and more recently and extensively on dry-powder inhalation products as senior manager, R&D, at Teva. Lacombe earned his MS and PhD in chemical engineering from Rutgers University.
Who Should Attend?
Manufacturing scientists and individuals involved in process development, formulation development, outsourcing, CMC, project management, procurement, technology strategy, inhalation, DPI, sourcing, quality, clinical operations, technical transfer, product engineering, R&D, formulation development and product development.
What You Will Learn
By attending this webinar, participants will:
- Understand the factors that influence inhalation formulation design and their impact on manufacturability
- How to incorporate filling trials into formulation development
- Why to perform a filling assessment as early as possible in the development process
- How early process experimentation serves as a tool to determine formulation feasibility or formulation strategy
Experic, a contract manufacturing organization (CMO) and pharmaceutical supply services company, supports every phase of a product’s life cycle from clinical to commercial scale, across a range of dosing and packaging formats, including capsule filling, powder and pellet dosing (including DPI), and autoinjectors and pen assemblies. Utilizing cutting-edge Harro Höfliger equipment in our state-of-the-art Class A GMP facility and build-to-suit suites, we manage global delivery of the highest quality products, even for expedited projects, while providing unparalleled knowledge, expertise and customer service.