Cambridge Healthtech Institute’s 13th Annual

Lyophilization and Emerging Drying Technologies
( 凍結乾燥技術と新たな乾燥技術 )

Emerging Strategies and Drying Technologies for Biologics

1月21日~22日

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 This conference will feature in-depth case studies, new and unpublished data and discussions on developing a scientifically sound freeze-dried formulation, process optimization for biologics and vaccines.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

1月21日(火)

1:00 pm Registration

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing

複雑な生物製剤や新規生物製剤に対応する乾燥技術

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 Sponsored Presentation (Opportunity Available)

3:45 Refreshment Break in the Exhibit Hall with Poster Viewing

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

5:45 - 8:45 Recommended Dinner Short Course*

SC5: Protein Aggregation: Mechanism, Characterization, and Consequences

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

1月22日(水)

7:45 am Registration and Morning Coffee

最新の乾燥技術

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.

9:20Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

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

1:45 PLENARY KEYNOTE PANEL

R&D CHALLENGES IN AN ERA OF INNOVATION

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

PAT、制御された核生成、容器施栓、サイクルの最適化

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

7:00 Close of Lyophilization and Emerging Drying Technologies Conference

Day 1 | Day 2

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。