Lonza

Join this webcast to learn formulation strategies to eliminate cold chain requirements for proteins using dry powders manufactured by spray drying.

https://www.pharmtech.com/pt/inhaler-protein

Inhaled delivery of biotherapeutic active pharmaceutical ingredients (APIs) is of growing importance in the pharmaceutical pipeline. When formulated as dry powders, local delivery of biologic molecules is possible without the need for cold-chain storage, facilitating a patient-centric treatment approach. In this webinar, the use of spray drying to manufacture dry powder formulations of protein APIs will be discussed. A case study will also be presented, in which an inhaled formulation of the antibody bevacizumab demonstrated 24-month stability at 25°C.

Understand formulation approaches for dry powder inhalers (DPIs) with protein-based APIs

Describe the key attributes of a room-temperature stable spray-dried powder of a biotherapeutic API

Appreciate the patient centricity of DPI formulations for lung delivery


Associate Director, Principal Engineer, R&D
Lonza Small Molecules

is a Principal Engineer in the research group at Lonza's site in Bend, Oregon, USA, where she has worked since 2015. She leads projects focused on developing new process and formulation technologies for inhaled delivery and bioavailability enhancement. Kim’s areas of expertise include the formulation and manufacturing of spray-dried dispersions for inhalation and oral delivery, as well as the physics of polymers and amorphous materials. Kim received her bachelor’s degree and master’s degree in Chemical Engineering from Stevens Institute of Technology and her Ph.D. in Chemical Engineering from Princeton University.

Webcasts

Webinar Date/Time: Thu, Jun 15, 2023 11:00 AM EDT

Stability of Dry Powder Inhaler Protein Formulations

Importance of speed and flexibility within early phase development

Benefits of working with an integrated CDMO

Videos

Interview with Lonza’s Sean Diver at DCAT 

Articles

A growing proportion of drugs in the development pipeline nowadays start out life at small biotech companies, rather than big pharma businesses. While this means the biotechs are taking on more risk, they will also reap greater rewards in the event of success. When it comes to choosing your CDMO partner, there is no substitute for a careful selection process to determine the right CDMO to make and manage your precious potential drug. In this podcast, David Hall, Senior Director, Commercial Development at Lonza Small Molecules, provides insights on how small and emerging pharmaceutical and biotech companies can navigate the evolving pharma development pipeline. 

CMC Challenges in the Small Molecule Development Pipeline

Podcasts

CMC Challenges in the Evolving Small Molecule Development Pipeline

With small molecule drugs becoming ever more complex and timelines increasingly aggressive, getting a new medicine onto the market has never been more challenging. Find out how choosing the right CDMO can be key to meeting CMC challenges and achieving regulatory success.

https://www.pharmtech.com/pt_w/cmc-and-cdmo

Small pharma companies are driving pipeline innovation and are increasingly taking more complex small molecules further down the development pipeline, if not all the way to market. The growth in expedited regulatory programs has added a need for greater speed onto the already significant list of challenges they face.
Yet, the molecules are also more likely to be complex in nature, whether because they are difficult to make or difficult to formulate. A significant proportion of the small molecules in development may as well be classified as “highly potent.” This adds the requirement for specialized handling capabilities.

Small biotechs are unlikely to have in-house capabilities, and selecting the right integrated CDMO has never been more important. Experienced CMC partners are critical in helping to avoid costly regulatory mis-steps. The right partner can be the difference between success and failure, and this webinar will explain what to look for.


Current pharma development pipeline trends

The importance of CMC in regulatory reviewWhat to look for in a CDMO CMC partner

Senior Director, Commercial
Development, Small Molecules
Lonza



 joined Lonza in 2021 and serves as Senior Director, Commercial Development for the EMEA and APAC regions within Lonza’s Small Molecule Division. David has more than 20 years’ experience in Senior Commercial and Operations roles, leading global CDMOs supporting both drug substance and drug product services.



Webinar Date/Time: Wed, Mar 1, 2023 11:00 AM EST


CMC and CDMO: The Importance of Choosing the Right Partner

When might multi-particulate technology be the best option for your dosage form, and how can they be made? Watch this webinar with Lonza experts to find out.

https://www.pharmtech.com/pt_w/multiparticulate

Multiparticulate technology is seeing increasing use in the pharmaceutical industry to enable modified release, high dose, and age-appropriate dosage forms. Familiarity with key concepts in technology selection, development, scale up and commercialization paths available for multiparticulate intermediates can be a barrier when deciding whether a multiparticulate approach might be enabling for your compound. This webinar is aimed at guiding formulators and CMC leads on decision criteria for selecting or excluding a multiparticulate approach in early phase development. Formulation and process selection will be discussed for key application areas of this technology, with a forward-looking view on the commercialization paths available. After watching this webinar, viewers will have a working knowledge of multiparticulate technology selection, development, and scale up paths, and commercial manufacturing options for this important class of pharmaceutical dosage forms. In particular, Lonza’s commercial melt-spray-congeal, fluid bed coating, and encapsulation technologies will be highlighted.

Understand decision criteria in technology selection for multiparticulates – where it can help, and where it won’t.

Develop a working knowledge of development and scale-up concepts for multiparticulate intermediates.

Understand the commercialization options available for key application areas.


Senior Engineer, Multiparticulate Product Development
Lonza


 has worked at Lonza for 8 years, having started in the Global Research and Development group located in Bend, Oregon, and then progressing to an engineering role in the Product Development group. Prior to working at Lonza, Hannah served as Assistant Operations Manager at Abengoa Bioenergy from 2013-2015. Hannah has a BS in Chemical Engineering from New Mexico Institute of Mining and Technology. She has made numerous contributions to spray drying and multiparticulate technologies while at Lonza, both in basic research and customer-facing roles, and is currently focused on commercialization of multiple multiparticulate programs.



Principal Investigator, Multiparticulate Product Development
Lonza


has worked with the Product Development team at Lonza for 8 years. Joel started his career at Lonza in the Spray Drying Engineering group, focusing on late-stage process development and commercialization readiness before bringing his expertise to the multiparticulate development group. Joel's current focus is on late-stage development of coated lipid-multiparticulate intermediates. Joel has a BS in Chemical Engineering from Bucknell University.


Webinar Date/Time: Thu, Feb 23, 2023 11:00 AM EST