Inhaled Biologics: Formulation, Analysis and Regulation

Life Sciences, Pharmaceutical Regulation, Drug Discovery & Development,
  • Monday, December 18, 2023

Discover an innovative webinar to explore the potential of inhaled biologics, with insights on formulation, analysis and regulatory considerations. While inhalation and biologics have been combined in notable ways such as insulin and dornase alfa, it has not been popularized broadly as a category. If inhalation is going to successfully combine with biologics, what current knowledge of formulating, analyzing and manufacturing inhaled small molecules will be useful and what other areas of expertise are needed?

This presentation will discuss how small molecule techniques can be applied to large molecules and where the current approach to biologics needs to be changed.

This webinar will delve into:

  • The definition of inhaled biologics
  • Formulation technologies, excipients and processing techniques that might be of value
  • The different analytical techniques needed for biologics
  • The regulatory implications of this type of combination product

Register for this webinar and delve into the synergy of inhaled biologics, gaining key insights into regulatory implications, formulation technologies and analytical techniques and paving the way for groundbreaking advancements.


Justin Lacombe, Experic LLC

Justin Lacombe, PhD, Chief Scientific Officer, Experic LLC

Justin Lacombe, PhD is the Chief Scientific Officer at Experic. Justin leads the pharmaceutical development and engineering teams to provide expertise, insights and practical solutions that address many of the technical challenges that pharmaceutical companies encounter during drug and combination product development.

Justin’s focus is on robust scale-up and process development using quality-by-design and design control principles. He has specialized expertise in manufacturing, combining small-volume powder dosing technology for powders with complex rheology, primary packaging development and formulation optimization. Based on his diverse experience, Justin has been a proponent of conducting powder filling studies earlier in the development process to avoid late-stage delays when scaling manufacturing processes to clinical and commercial quantities.

In previous roles, Justin was deeply involved in the development of inhaled pharmaceutical products, initially on metered dose inhalers at Catalent Pharma Solutions, and more recently and extensively on dry-powder inhalation products as Senior Manager, R&D, at Teva, from particle engineering to fill and finish. Justin earned his MS and PhD in Chemical Engineering from Rutgers University and has presented extensively on topics of manufacturing drug product interaction, process development optimization and drug-device combination products.

Message Presenter

Who Should Attend?

This webinar will appeal to Manufacturing Scientists and individuals in the following fields that are involved in the research and development of biologics:

  • Formulation development
  • Process development
  • Product engineering and development
  • Outsourcing
  • CMC
  • Project management
  • Procurement
  • Technology strategy
  • Inhalation
  • DPI
  • Quality
  • Technical transfer

What You Will Learn

Attendees will gain insights into:

  • Technologies and regulatory implications for inhaled biologics
  • Device, drug delivery, formulation and other technical considerations when developing inhaled biologics

Xtalks Partner


Experic, a contract development and manufacturing organization (CDMO) and clinical trial supply services company, supports every phase of a product’s life cycle from conception to clinical and commercial scale, across a range of dosing and packaging formats, including tablets, pellets, capsules, and low dose dry powder inhalation. From our state-of-the-art, Class A cGMP facility, we manage global delivery of the highest quality products, even for expedited projects, while providing unparalleled knowledge, expertise, and customer service. Learn more about our formulation, spray drying, development, manufacturing, analytical, and clinical supply services at

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