Solving the Lyo Cycle: Science & Technology for Modern Lyophilization

The Use of AI and Machine Learning in Cycle Development Lyo Cycle Design

Current state of 'Off the Shelf' machine learning agents in lyo cycle design
Leveraging 30 years of Biopharma Group's in-house data to build a bespoke AI assistant (LyoML)
Comparing LyoML with generic AI models: strengths, limitations, and use cases

Design of Experiments for Lyobead Formulation Development

The power of DoE for formulation development
Metrics for lyobeads and shift in focus from typical lyophiles
Case study: DoE for a medical diagnostic lyobead product

Machine Learning Powered Collapse Detection Through Image Recognition

Critical temperature detemination using FDM as a fundamental starting point for cycle design
Limitations of current software used for collapse detection and critical temperature analysis
Development of an AI-driven image recognition model for automated critical temperature determination using Biopharma Technology's in-house image datasets

Lyophilization in Syringes: An Integrated Approach to Cycle Development and Manufacturing

Abstract: This presentation explores how syringe configuration influences heat transfer and cycle development, then broadens the discussion to the interconnected product, process, equipment, and analytical considerations required for successful implementation. Practical examples illustrate how decisions made throughout development can affect manufacturability and product performance. Together, these considerations provide a framework for developing a robust lyophilized syringe product from cycle design through manufacturing.

Navigating On-Board Reagent Integration & Lyophilization Strategies

Abstract: This discussion will explore key considerations for integrating reagents directly into diagnostic consumables, with an emphasis on lyophilization as a strategy for improving reagent stability, simplifying workflows, and enabling room-temperature storage. We will review practical approaches to reagent formulation, lyophilization, on-board storage and rehydration, while highlighting common development challenges and design considerations for successfully integrating lyophilized reagents into manufacturable consumable formats.

Lyophilization of Nucleic Acid Extraction Reagents

Abstract: The next-generation Grifols molecular diagnostics platform aims to implement room temperature reagent storage and increase multiplexing capabilities. To support this goal, a universal workflow was developed to evaluate magnetic bead-based nucleic acid extraction chemistries for recovery of viral targets across diverse sample matrices. Candidate chemistries were assessed for extraction efficiency, automation compatibility, stability, and integration into a simplified workflow. Lead chemistries demonstrated robust performance and were advanced for platform development. This approach has the potential to improve workflow efficiency, reduce environmental impact, and support highly multiplexed molecular testing.

Humidity-Induced Collapse in Freeze Dried Cakes by Dynamic Vapor Sorption

Abstract: The interaction of freeze-dried materials with residual water can be critical in determining their activity/potency and long-term stability. Dynamic Vapor Sorption (DVS) experiments provide insight into the kinetics and extent of moisture sorption and desorption in lyophilized materials, which can inform formulation design, primary packaging selection, lyo cycle development, and aspects of post-lyo handling. This presentation will highlight some of the issues encountered for lyo products in these respects and present some real-life case studies to demonstrate the scientific and practical value of DVS as a technique.

What can DVS tell us about product-water interactions?
The use of DVS to quantify container permeability
Taking detail to the next level by coupling DVS with LF-NMR

Non-destructive Measurement of Headspace Moisture Using Frequency Modulation Spectroscopy (FMS)

Rapid generation of data for 100% batch inspection
Using DVS to establish the true meaning of HSM
Water activity: helping end-users comply with USP<922>

Case Studies in Understanding Moisture for Pharmaceutical, Biological and Diagnostic Products

Why do different methods give me different results?
Effects of formulation ingredients and process conditions
Seeing past the artefacts to reveal the true picture

Panel Discussion and Q&A Session on Residual Moisture

Harnessing Technology For The Perfect Lyobead

Dr. Kevin Ward

Biopharma Group

Kevin is a globally recognised expert in lyophilization, with more than 30 years of experience in freeze-drying science and technology. Since joining Biopharma Group in 2000, he has led and contributed to over 5,000 customer projects worldwide, spanning pharmaceutical, biotechnology, and diagnostic applications. Kevin earned his PhD for research into the freeze-drying of pharmaceutical formulations and drug and vaccine delivery systems.

Sam Woodyard

Biopharma Group

Sam joined us in 2020 as a Research Assistant after earning a degree in Biological Sciences from Reading University, where he specialised in molecular biology and biochemistry. He further honed his skills with a research project in the cardiovascular lab, focusing on protein expression in murine red blood cells. Since progressing to Research Scientist in 2022, Sam has been instrumental in managing projects, cycle recipe development, developing freeze-drying formulations, and performing pre- and post-lyophilization analyses.