Lonza

Are you ready to unlock the secret to seamless commercial tech transfers in oral solid dosage manufacturing? In this webinar, industry experts will describe proven strategies for accelerated process validation, ensuring quality consistency, and making use of cutting-edge equipment. Whether you’re navigating regulatory hurdles or optimizing processes, this session will give you insights into the art of a successful pharmaceutical tech transfer.

https://www.pharmtech.com/pt_w/commercial-tech-transfers

This presentation will explore the critical aspects of manufacturing commercial tech transfers for the manufacture of oral solid dosage (OSD) products. It will provide insights into the progression of process validation for existing commercial products, ensuring consistent quality, and navigating regulatory requirements. The discussion will also highlight Lonza’s advanced equipment capabilities, showcasing the company’s role in streamlining tech transfers and enhancing operational efficiency.




Gain insight into the tech transfer process

Learn about Lonza’s equipment capabilities

Discover how to effectively navigate operational challenges


Manufacturing Science and Technology Senior Engineer
Lonza

Rebecca Peek is a seasoned engineering professional with more than a decade of industry experience in oral solid dosage (OSD) manufacturing and pharmaceutical operations. She brings a wealth of expertise in leading successful technology transfer projects, process validations, and driving commercial approvals. Rebecca has a strong foundation in biomedical engineering and managing complex initiatives that bridge technical and regulatory requirements. She is experienced in the intricacies of scaling up OSD production, optimizing manufacturing processes, and utilizing cutting-edge technologies to enhance operational efficiency. Rebecca is very experienced in the execution of end-to-end process validations, ensuring alignment with rigorous quality standards and regulatory compliance, directly contributing to the approval and launch of multiple OSD products. She routinely works with diverse cross-functional teams, including R&D, manufacturing, and regulatory affairs, to streamline workflows and processes. She holds a project management professional (PMP) certification.




Manufacturing Science and Technology Engineer
Lonza

Laura Treche is a manufacturing science and technology engineer with a strong background in oral solid dosage manufacturing. With hands-on experience in technology transfer, process scale-up, and optimization, Laura has successfully supported the transition of products into commercial manufacturing, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. She is adept at troubleshooting, process validation, and continuous improvement, maintaining a strong commitment to product quality and operational efficiency. Laura works closely with cross-functional teams, including R&D, quality, and regulatory departments, to drive the successful commercialization of small molecules. She is an asset in aligning manufacturing processes with business goals and regulatory requirements.


Webcasts

Webinar Date/Time: Tuesday, March 11, 2025 | 11:00 AM EDT / 3:00 PM GMT


Commercial Tech Transfers in OSD Manufacturing

Articles

This executive summary focuses on dose-flexible manufacturing strategies and their role in drug
development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as
pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized
early in development. This presentation will focus on technical strategies that can help anticipate appropriate
timing for implementation and how to do so cost effectively while adhering to required timelines.


Flexible-Dose Development Strategies for Today's Clinical Landscape - Executive Summary

Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations


Beyond Jet Milling: A Deep Dive into Carrier-Based Formulation and Process Optimization - Executive Summary

Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza's future and how that works in tandem to meet client needs.

Lonza's Commitment to the Future (Dec 2024) 

Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up
from small screening batches to commercial levels. By leveraging small-scale experiments for process design
and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for
small-molecule drug products. 

Risk-Based Development Supporting Process Qualification for Spray-Dried Dispersion

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.

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