Cambridge Healthtech Institute’s 13th Annual
Lyophilization and Emerging Drying Technologies
Emerging Strategies and Drying Technologies for Biologics
January 21-22, 2020
Part of the Formulation & Stability pipeline
The popular 13th Annual Lyophilization and Emerging Drying Technologies conference covers the latest trends, advances, and challenges in lyophilization and emerging drying technologies. This conference will feature in-depth case studies, new and unpublished
data and discussions on developing a scientifically sound freeze-dried formulation, process optimization for biologics and vaccines. It will also present cutting-edge research and case studies on formulation challenges of freeze-dried formulation
and cell, gene, and tissue-based products.
Final Agenda
Day 1 | Day 2 | Download Brochure
TUESDAY, JANUARY 21
1:00 pm Registration (Sapphire West Foyer)
1:30 Refreshment Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
2:00 Chairperson’s Opening Remarks
Xiuling Lu, PhD, Associate Professor, Pharmaceutical Sciences, University of Connecticut
FEATURED PRESENTATION
2:05 Impact of Freeze-Drying Process and Lyoprotectants on Nanoparticle Stability
Xiuling Lu, PhD, Associate Professor, Pharmaceutical Sciences, University of Connecticut
Freeze-drying is an effective approach to improve the storage stability of nanomedicines. The optimal freeze-drying process and lyoprotectants for three types of nanoparticles (solid lipid nanoparticles, polymeric nanoparticles, and liposomes) were investigated.
It was identified that various nanoparticle platforms have different behaviors in the freeze-drying process and require appropriate approaches to cope with. The impact of lyoprotectant selection and the freeze-drying process on nanoparticle stability
will be presented.
2:45 Stabilization of Gene Therapy and Cell Therapy Drug Products Using Lyophilization and Vetrification Strategies
Rajiv Nayar, PhD, President, HTD Biosystems, Inc.
Currently, nucleic acid-based and cell therapy drug products are formulated as frozen drug dosage forms or liquid dosages with limited shelf life. This makes them restricted to only be available at specialized institutions and specific geographic locations.
Lyophilization of such drug products would enhance their stability and increase their availability. This presentation will address issues and strategies to overcome the limitations of these next-generation biopharmaceuticals.
3:15 Selected Poster Presentation: Dehydration Induced Structural Transition of Proteins and Its Thermal Stability in Solid/Semi-Solid Formulation
Tuan Phan, PhD, Researcher, Biology, Malmo University
Proteins when dehydrated may adopt different conformations which most likely affects its stability. In this contribution, synchrotron small and wide angle X-ray scattering are used together with DSC and Raman spectroscopy to characterize the structure of a model protein, lysozyme, in the solid state and its structural transition upon rehydration. Relationship between protein structure, excipients, and moisture in relation to the protein’s thermal stability will also be discussed.
3:45 Refreshment Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
Aqua D
4:30 Lyocycle Development for AAV-Based Gene Therapy Applications- Challenges and Opportunities
Tanvir Tabish, MSc, Head of Formulation Development, Formulation, Fill and Finish, Takeda
Biopharmaceuticals show varying levels of stability in aqueous solutions for short periods of time. Lyophilisation is a technique commonly used to improve the stability profile of biomolecules through the removal of water resulting in the increasingly
restricted mobility of the reacting species. The Factor IX (FIX) gene therapy product was formulated and lyophilized. A stability study was established with the lyophilized material to determine its stability profile at the accelerated temperature
at 5°C.
5:15 Extended Q&A with the Speaker
5:30 Close of Day
5:30 - 5:45 Short Course Registration (Sapphire West Foyer)
5:45 - 8:45 Recommended Dinner Short Course*
SC5: Protein Aggregation: Mechanism, Characterization, and Consequences - Detailed Agenda
Instructors:
Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Kevin Mattison, PhD, Principal Scientist, Malvern Pananalytical, Inc.
*Separate registration required
Day 1 | Day 2 | Download Brochure
WEDNESDAY, JANUARY 22
7:45 am Registration (Sapphire West Foyer) and Morning Coffee (Sapphire West & Aqua West Foyer)
8:15 Chairperson’s Remarks
Bakul Bhatnagar, PhD, Senior Principal Scientist, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
8:20 Exploring Novel Drying Technologies for Generating Monoclonal Antibody Powders in Consideration of Critical Quality Attributes
Benson Gikanga, Senior Engineer, Pharmaceutical Processing and Technology Development, Genentech
Some novel spray drying technologies proved feasible in producing powders of monoclonal antibody formulations with acceptable particle characteristics (particle size distribution, morphology, moisture content, etc) while maintaining key quality attributes
(cQAs), including charge and size variants. They also demonstrated stability performance comparable to freeze drying. Despite these promising data, this presentation offers insights into changes in other cQAs, which pose challenges in utilization
of spray drying technologies for dehydration of biopharmaceutical products.
8:50 New Technologies for Freeze-Dried Formulations and Continuous Manufacturing
Bakul Bhatnagar, PhD, Senior Principal Scientist, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
While the pharmaceutical industry continues to demonstrate its creativity associated with novel compounds in development, the processing technologies utilized for their manufacture have not kept their pace. This is not a reflection of the paucity of innovation
associated with processing technology. The barrier can broadly be classified as economic, logistical, technical and psychological, and all elements need to be overcome for successful implementation of new technology.
9:20 Selected Poster Presentation: Investigating the Effect of Glycerol on the Thermal and Mechanical Properties of Model Biotherapeutic Formulations During Lyophilization and Its Effect on the Resulting Physical Robustness of Cakes
Charles Hauswald, MS, MBA, US Sales Manager Biophama Technology
Freeze-dried protein-based formulations were investigated varying concentrations of glycerol and excipients to understand their influence on their thermal properties, water sorption behavior, and mechanical properties. The addition of glycerol was shown to have a negative impact on the thermal properties of a number of frozen formulations but could positively influenced the mechanical properties of the final freeze-dried cakes.
9:50 Coffee Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
KEYNOTE PRESENTATION
10:35 New Approaches to Make Freeze Drying of Proteins Faster and Better
Gerhard Winter, PhD, Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen
To improve freeze drying, two aspects have been in the focus of recent research. First, to speed up the process to reduce time, and second, to make it more homogeneous, particularly with respect to ice nucleation. We will present our newest research results
on microwave assisted freeze drying, applicability of tBA in protein freeze drying and conclusive studies of stability of lyophilisated in relation to controlled or random ice nucleation.
11:05 µ-Raman Spectroscopy Used for Understanding the Mechanisms of Protein Stabilization During Freeze-Drying
Starciuc Tatiana, PhD, Assistant Professor, Material Sciences, University of Lille
Freeze drying is widely considered as a method of choice for drying biologicals characterized by a delicate structure. Sugars are recognized to protect these macromolecules even at complete desiccation. We have recently developed µ-Raman investigations
on protein formulations, mimicking FD cycles, which enable the simultaneous monitoring of the process and the protein stability. These investigations allowed to study the relationship between the spatial distribution of the formulation components
and protein stability.
11:35 PANEL DISCUSSION: Challenges in Developing and Implementing Drying Technologies for New and Complex Biologics
Discussion Points:
- Drying of novel biotherapeutics, cell and gene therapy products, tissues, particles, etc.
- What are the standards and good starting points?
- What are some alternative drying technologies?
- How to scale up and implement for large scale continuous manufacturing
Moderator:
Rajiv Nayar, PhD, President, HTD Biosystems, Inc.
Panelists:
Benson Gikanga, Senior Engineer, Pharmaceutical Processing and Technology Development, Genentech
Evgenyi Shalaev, PhD, Executive Director, Pharmaceutical Development, Allergan plc
Gerhard Winter, PhD, Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen
Tanvir Tabish, MSc, Head of Formulation Development, Formulation, Fill and Finish, Takeda
12:05 pm Session Break
12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:15 Session Break
Aqua Salon
1:45 PLENARY KEYNOTE PANEL
The PepTalk Plenary Keynote Panel convenes a group of leading scientists working across novel therapeutic modalities and R&D technologies to explore the many challenges associated with discovering, developing, and advancing today’s novel biotherapeutics.
The Panel, via a highly interactive format, encourages discussion among both the panelists and the audience members. Please come prepared with your questions and ideas for this spirited discussion.
- Advances and challenges in expression and production for novel modalities
- Implementing next-generation informatics: data collection, standardization, analysis, ML/AI, and considerations for IP landscape and protection
- Implementing R&D and production capacity for gene and cell therapies – where are we heading?
- Modality-specific challenges: multi-specifics for cancer, improving the ADC therapeutic window, improved safety and pharmacology, novel delivery/targeting
- Preclinical and clinical development of drug combinations with focus in IO: How do we select the right combination dose so we can accelerate clinical development?
Moderator:
Mohammad Tabrizi, PhD, Senior Director, Pharmacology, Ascendis Pharma A/S
PANELISTS
Edward Kraft, PhD, Senior Scientific Manager, Biomolecular Resources, Genentech
Ilya Shestopalov, PhD, Associate Director, Cell Analytics, bluebird bio
David E. Szymkowski, PhD, Vice President, Cell Biology, Xencor, Inc.
Alayna George Thompson, PhD, Senior Scientist I, Drug Discovery Science & Technology, AbbVie
3:05 Refreshment Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
4:00 Chairperson’s Remarks
Evgenyi Shalaev, PhD, Executive Director, Pharmaceutical Development, Allergan plc
4:05 PAT in Freeze-Drying: Detection of Secondary Crystallization of Excipient+Water
Evgenyi Shalaev, PhD, Executive Director, Pharmaceutical Development, Allergan plc
Crystallization of an excipient or an active ingredient during freeze drying could have a major impact on the product yield (e.g., vial breakage), manufacturing process (e.g., the drying rate), and quality attributes of the finished product, including
appearance, reconstitution, potency, and stability. The presentation overviews main experimental tools for monitoring secondary solute crystallization during freeze drying, including product temperature, electrical resistance, spectroscopy (such as
Raman), and heat-flux sensors.
4:35 Characterization of Moisture Uptake of Lyophilized Drug Product from Different Stoppers
Pauline Che, MSc, Engineer II, Pharmaceutical Development, Genentech
Post-lyophilized drug product residual moisture may increase with time from stopper-bound moisture and from water vapor permeation through stopper. This work evaluates the impact of stopper size, stopper type, initial stopper moisture content, and drug
product storage conditions on residual moisture uptake rate. Data package generated will support stopper moisture specification prior to product fill and predict residual moisture of lyophilized drug product at end of shelf life.
5:05 Small-Angle Scattering of Surfactants and Protein-Surfactant Mixtures during Freeze-Thaw
Xiaoda Yuan, PhD, Scientist, Pharmaceutical Development, Allergan, Inc.
Frozen storage represents one of the most common preservation methods for biotherapeutics. Surfactant is a typical component in biopharmaceutical formulations for its protective role against interfacial stresses. This presentation will discuss phase behaviors
of surfactants and protein-surfactant mixtures during freeze-thaw as studied by small-angle scattering techniques (X-ray and neutron scattering). Different surfactants (PS 20 and P 188) and surfactant concentrations were compared. Lysozyme was used
as a model protein.
5:35 Evaluation of Optical Coherence Tomography – Freeze Drying Microscopy (OCT-FDM) for Lyophilization Cycle Development
Andrew Massetti, Senior Associate Scientist, Protein Pharmaceutical Development, Biogen
Traditional techniques used to estimate product collapse temperature (Tc) may not be representative of the actual drying process in vials, the most commonly used commercial container closure. Optical coherence tomography freeze drying microscopy (OCT-FDM)
allows direct Tc measurement in vials and has the potential to enable development of more efficient drying process. Freeze drying cycles were developed by OCT-FDM and the resulting product quality was compared to cycles developed by traditional techniques.
6:05 - 7:00 Networking Reception in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
7:00 Close of Lyophilization and Emerging Drying Technologies Conference
Day 1 | Day 2 | Download Brochure