Lonza

The identification of the unique risks to oral bioavailability is critical for identifying appropriate enabled forms and formulations.

https://www.pharmtech.com/pt_w/amorphous-solid-dispersions

The rapid development of enabled forms and formulations is essential if the challenges posed by poorly soluble molecules entering the development pipeline are to be overcome. The identification of the unique risks to oral bioavailability is critical for identifying appropriate enabled forms and formulations. The webcast will describe some of the material-sparing techniques used at Lonza. These include:

Physiologically based pharmacokinetic (PBPK) modeling

Gain insight into how Lonza’s formulation development process can improve bioavailability

Learn about the advantages of material-sparing formulation

Discover how excipient compatibility and drug product formulation can be explored together via compaction simulation and other modeling tools

Scientists involved in Drug Formulation and metabolism; Pharmacokinetics; and Physiologically based Pharmacokinetics Modeling.

Chemistry, Manufacturing, and Controls colleagues looking for rapid formulation screening methodologies.

Experts in Solid Form, Amorphous Solid Dispersion, and Solid Dosage Forms who want to learn more about Early Formulation Screening.


Manager, Bioavailability Enhancement Engineering
Lonza Small Molecules

Hannah Worrest is a Manager in Bioavailability Enhancement (Product Development). Hannah leads a group of spray drying engineers dedicated to the success of clinical and commercial manufacturing. Additionally, she drives initiatives aimed at improving the use of historical data to build predictive models for spray drying processes such as the particle size prediction application of the Lonza spray drying thermo model. Worrest received her bachelor’s degree in chemical engineering from Montana State University.




Bioavailability Enhancement Engineer
Lonza Small Molecules

Bailey Coker, MEng, is an engineer specializing in Bioavailability Enhancement within product development. As the engineering lead on clinical programs for both spray-dried dispersions and solid dosage forms, she plays a pivotal role in advancing innovative solutions. Her expertise is centered on the scale-up and technology transfer processes for early-phase clinical initiatives, ensuring seamless transitions from development to clinical manufacture. Bailey holds a bachelor’s degree in Chemical Engineering and a master’s degree in Biomedical Engineering from Colorado State University.




Manager, Bioavailability Enhancement Engineering
Lonza Small Molecules

Dr.DuRoss is a Manager in Bioavailability Enhancement (Product Development). Allison leads a group of solid dosage engineers dedicated to the success of clinical and commercial manufacturing. Additionally, she supports innovation and integration of new technologies into product development. Most recently, she worked with the solid dosage team to redefine the feasibility and scale-up offering at Lonza improving formulations and processes through the capabilities of the Styl’One Evo compaction simulator. She received her B.S.E. in Chemical Engineering from the University of Michigan and Ph.D. in Pharmaceutical Sciences from Oregon State University.

Webcasts

Webinar Date/Time: Tuesday, November 19 2024 at 11: 00 AM EST | 5:00 PM CET


Linking rational design and material-sparing strategies for enabled intermediates and their drug products.

Excipients play a crucial role in the stability, safety, and efficacy of these therapies.

https://www.pharmtech.com/pt_w/respiratory-delivery-of-biologics

Local administration of biologic Active Pharmaceutical Ingredients to the lung via inhalation has grown in recent years. Dry and liquid dosage forms of protein-, peptide-, and nucleic acid-based therapies have been developed for respiratory delivery in clinical trials and as final commercial products. Excipients play a crucial role in the stability, safety, and efficacy of these therapies. However, there are still some challenges surrounding excipients within the respiratory arena, mostly driven by regulatory and technical aspects. This webinar will cover:

Regulatory landscape for respiratory excipients

Role of excipients in biologic API stabilization

Specific considerations for formulating liquid and dry dosage forms

Challenges and opportunities for respiratory excipients

Understand the regulatory status of key inhalation excipients

Recognize the role of excipients in stabilization of biologic APIs

Differentiate between the formulation needs of liquid and dry powder dosage forms for inhalation


Director, Respiratory Delivery
Lonza Small Molecules

Kimberly Shepard, PhD, is the Director of Respiratory Delivery at Lonza Bend, leading a group which specializes in dry powder inhaler delivery of small and large molecules to the lung and nose. Prior to this role, Kim worked in the research and development group at Lonza Bend for 8 years, on programs involving the spray drying of proteins, amorphous solid dispersion formulations for solubility enhancement, and the spray drying process development. Kim obtained her PhD in chemical and biological engineering from Princeton University, focusing on polymer physics and amorphous materials. She earned her B.E/M.E from Stevens Institute of Technology, also in chemical engineering.




Inhalation, Respiratory Delivery
Lonza Small Molecules

Michael Shultz, PhD, is a Manager for Respiratory Delivery at Lonza Bend, focusing on formulation and characterization of spray-dried biologics for respiratory delivery. Prior to working with Lonza, Michael worked in various capacities in the biotechnology industry, academia, and government for nearly 20 years. In these roles, he primarily focused on high-throughput nucleic acid and protein diagnostics research and development. He obtained his PhD in pharmacology and toxicology from the University of California, Davis, focusing on species susceptibility differences by cytochrome P450-activated lung toxicants.




Technical Project Lead
invoX Belgium

Diana Fernandes, PhD, is a founder of and consultant at OnResp, Copenhagen, Denmark, currently working as a Technical Project Lead at the invoX Respiratory Innovation Center of Belgium. She is responsible for the portfolio of innovator and research programs of soft mist inhalation combination products (biologics and small molecules). She also works with respective teams and supply chain, from early-stage development to regulatory submission. Previously, Diana worked within the pharma contract development and manufacturing organization sector. She also has experience with research and development services as a Drug Product Development Scientist at Hovione Farmaciência, Lisbon/Loures, Portugal. Here, she led the experimental design, tech-transfer, and scale-up development of dry powder inhalation programs, namely formulation and spray drying processes of biological clinical products, from lab to pilot and production. She earned her industrial PhD in pharmaceutical technology from Faculty of Pharmacy, University of Lisbon in collaboration with Hovione Farmaciência. She also holds an MSc and BSc in biological engineering from Instituto Superior Técnico, University of Lisbon, Portugal.

Webinar Date/Time: Tuesday, November 12, 2024 at 11am EST | 5pm CET


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