Cambridge Healthtech Institute’s 12th Annual
Lyophilization and Emerging Drying Technologies
January 15-16, 2019
The popular 12th Annual Lyophilization and Emerging Drying Technologies conference covers 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 This conference will feature in-depth case studies, new and unpublished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 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. In addition, this conference will aim to address drying in cartridges, storage stability, cell, gene and tissue based products, QbD and PAT approaches for scale-up from R&D scale to full production level,
and selection of container closure systems.
Final Agenda
TUESDAY, JANUARY 15
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
Robin Bogner, PhD, Professor, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut
KEYNOTE PRESENTATION
2:05 Overcoming Implementation Challenges of Novel Drying Technologies and Continuous Manufacture
Satoshi Ohtake, PhD, Senior Director, Pharmaceutical Research and Development, Biotherapeutic 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 a new technology.
2:45 Predictive Models of Lyophilization Process for Development, Scale-Up/Tech Transfer and Manufacturing
Ehab Moussa, PhD, Senior Scientist, Drug Product Development, AbbVie,
Inc.
Scale-up and technology transfer of lyophilization processes remains a challenge that requires thorough characterization of the laboratory and larger scale lyophilizers. In this study, computational fluid dynamics and steady state heat and mass transfer
modeling of the vial were utilized for scale-up and technology transfer. The models were verified experimentally for lyophilizers of different scales and were then applied to create and evaluate a design space for a drug product.
3:15 Wireless Multipoint Temperature Sensors for Monitoring Pharmaceutical Lyophilization
Dimitrios Peroulis, PhD, Associate Dean for External
Affairs, College of Engineering, Purdue University
In this talk, we discuss the design and evaluation of a fully wireless, multi-point temperature sensor system as a Process Analytical Technology (PAT) for lyophilization. Each sensor contains seven sensing elements which measure the product temperature
at various positions of the contents of a glass vial. The sensor performance has been validated through a variety of freeze-drying experiments.
3:45 Refreshment Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
QBD, PROCESS ANALYTICAL TECHNOLOGY, MODELING, AND CONTROL
Sapphire 410
4:30 Novel Methods to Study Effects of Moisture and Formulation on the Stability of Lyophilized Proteins
Anna Millqvist Fureby, PhD, Centre Director, NextBioForm; Senior Scientist,
Surface, Process and Formulation, RISE Research Institutes of Sweden
Lyophilized protein formulations are influenced by composition processing and moisture. The distribution of protein and excipients is non-uniform, as studied by confocal Raman spectroscopy and other spectroscopic techniques. Moisture influences both the
material properties and the stability of the protein, as studied by sorption calorimetry, DSC and high-resolution scattering techniques. A combination of analytical techniques enables a more comprehensive mechanistic understanding of protein stability
in lyophilized formulations.
5:00 CO-PRESENTATION: Detection of Protein Tertiary Conformational Changes in Lyophilized Protein in the Solid State
Robin Bogner, PhD, Professor, Department of Pharmaceutical Sciences,
School of Pharmacy, University of Connecticut
Lauren Fontana, Doctoral Candidate, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut
A simple analysis of the lyophilized protein solid immediately after processing (requiring no reconstitution) that predicts stability would be ideal. FTIR is used to monitor secondary structural changes, but with limited prediction ability. Raman spectroscopy
has more recently been suggested to characterize both secondary and tertiary protein structure in the solid state. Principal component analysis of Raman spectra can detect some of the subtler structural changes.
5:30 Close of Day
5:30 - 5:45 Short Course Registration
5:45 - 8:45 Recommended Dinner Short Courses*
SC3: Protein Aggregation: Mechanism, Characterization and Consequences
Click here for more details.
*Separate registration required
WEDNESDAY, JANUARY 16
7:45 am Registration and Morning Coffee (Sapphire West Foyer)
8:15 Chairperson’s Remarks
Satoshi Ohtake, PhD, Senior Director, Pharmaceutical Research and Development, Biotherapeutic Pharmaceutical Sciences, Pfizer, Inc.
8:20 Developing Low-Frequency Raman Methods to Predict Lyophilized Protein Stability
Marcus T. Cicerone, PhD, Project Leader, Biomaterials Group,
National Institute of Standards and Technology
Lyophilized protein stability strongly correlates with fundamental steps of transport found at the picosecond timescale. In the past, these dynamic events have been measured by neutron scattering. We are developing benchtop optical approaches, particularly
low-frequency Raman scattering, to be used as a rapid predictor of lyophilized protein stability.
8:50 Back to Basics: Lyophilization Cycle Development for Stabilizing Complex Glycoproteins
Wendy Sunderland, BS, MBA, Director, Drug Product Development, Technical Operations, Amicus Therapeutics
The tendency when developing a lyophilized biologic is to be conservative, resulting in a product with necessary critical attributes, but an excessively long cycle. Lyophilizers are then greatly stressed, employing low shelf temperatures and chamber
pressures, for a longer time, increasing risk for product failure. A case study will be presented for the lyophilization cycle development of a complex glycoprotein, thus reducing cycle time by half and increasing potential for success.
9:20 SELECTED POSTER PRESENTATION: Implications of Freezing Characteristics and Primary Drying Conditions on Porous Structure of Lyophilized Formulations Containing Highly Concentrated Proteins
Shreya Kulkarni, PhD Candidate, Department of Pharmaceutical Sciences, University of Connecticut
Porous structure is an important attribute for lyophilized drug products having implications on reconstitution time, mechanical integrity, dry layer resistance and protein stability. The present work investigates the effect of freezing characteristics
namely ice nucleation temperature, residence time, viscosity during freezing and annealing and on porous structure. Furthermore, it also evaluates the effect of primary drying conditions (aggressive vs. conservative).
9:50 Coffee Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
10:35 Development of Vacuum-Foam Drying for Preservation of Human T Cells
Bryan Balthazor, MA, Scientist, Pharmaceutical Research
and Development, Pfizer, Inc.
Vacuum-foam drying (VFD) is a novel pharmaceutical drying technology that uses evaporation to rapidly remove water, forming a solid foam structure. VFD has unique benefits, such as processing at near-ambient conditions, which can enable the drying
of sensitive biologics. A case study is presented here using human T cells to demonstrate formulation, processing, and VFD optimization in order to minimize drying stresses and enable refrigerated storage of human T cells.
11:05 Atmospheric Spray Freeze Drying: The ASFD Future Is Dawning
Thomas D. Robinson, MD, Managing Director, DNA, Aerosol Therapeutics, LLC
Atmospheric Spray Freeze Drying (ASFD) is an innovative, “next-generation” process with broad utility. The process yields a fine, uniform powder. Specifically, the patented ASFD process promises an efficient, cost effective alternative
to standard manufacturing processes. Although ideal for heat sensitive products and especially the more expensive, easily degraded proteins, the ASFD process can dry any solution, even the more concentrated solutions, to a target level moisture
content.
11:35 Challenges in Stabilization of the Next Generation of Medicines: Cells and Tissue-Based Products
Rajiv Nayar, PhD, President, HTD Biosystems, Inc.
12:05 pm Session Break
12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:15 Session Break
PLENARY KEYNOTE PANEL (Aqua Salon)
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PepTalk Perspectives: Point-Counterpoint Discussions
2:00 Plenary Keynote Introduction
Norman Packard, PhD, CEO, Daptics
2:10 Plenary Keynote Panel
Moderator:
Howard Levine, PhD, President and CEO, BioProcess Technology Consultants
Panelists:
George Badescu, PhD, Vice President, Scientific Affairs, Heidelberg Pharma AG
Manon Cox, PhD, Co-Founder & CEO, NextWaveBio
Zhimei Du, PhD, Director, Bioprocess & Clinical Manufacturing, Merck
Paul Jorjorian, Vice President, BioProcess Sciences, Thermo Fisher Scientific
Marina Kirkitadze, PhD, Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur, Canada
Stefan R. Schmidt, PhD, MBA, Head, Operations (COO), BioAtrium AG
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, Inc.
4:05 Impact of Silicone Oil on Fatty Acid Solubility and Polysorbate Related Particle Formation
Raphael Fish, Engineer I, Process Development, Genentech
Silicone oil coating on the interior of pre-filled syringes may act as a sink for fatty acids that are released upon hydrolytic degradation of polysorbates, potentially reducing risk of particle formation. Free fatty acids were shown to partition
from an aqueous to a silicone oil phase in a glass vial model. However, the partitioning effect was not large enough to translate to significant reduction in particle formation risk at representative conditions. It was concluded that silicone
oil levels in a PFS are too low to have any meaningful impact on polysorbate-related particle formation.
4:35 NEW TALK: Heterogeneity Across the Lyophilization Batch
Robin Bogner, PhD, Professor, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut
5:05 Phase Behavior of an Alternative Surfactant, Poloxamer, during Freeze-Drying
Evgenyi Shalaev, PhD, Executive Director, Pharmaceutical
Development, Allergan, Inc.
Poloxamers (e.g., P188) have been recently considered as alternative surfactants to polysorbates (tween20 and 80), as the latter are easily oxidized and can also undergo hydrolysis. In this study, complex phase behavior of aqueous solutions of
a poloxamer is investigated using DSC, small-angle neutron scattering, and small- and wide-angle X-ray scattering.
5:35 SELECTED POSTER PRESENTATION: Effect of Freeze-Thaw Process Parameters on Stability of Lactate Dehydrogenase
Bruna Minatovicz, PhD Candidate, Department of Pharmaceutical Sciences, University of Connecticut
Storage of biotherapeutics in a frozen state provides operational flexibility and extends the shelf life of protein solutions. This presentation will provide an overview of the impact of freeze-and-thaw process parameters on the stability of a
model protein, lactate dehydrogenase, at a large scale. A phase-field theoretical model will further provide the mechanistic understanding of possible stresses arising during the freezing process and their ultimate effect on the protein stability.
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