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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 This conference will feature in-depth case studies, new and unpublished data, and discussions on developing scientifically sound freeze-dried formulation, process optimization for biologics and vaccines.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. We are seeking cutting edge research findings and unpublished data to be featured at this forum.

Final Agenda

TUESDAY, JANUARY 15

1:00 pm Registration

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

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.

QBD, PROCESS ANALYTICAL TECHNOLOGY, MODELING, AND CONTROL

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 Sponsored Presentation (Opportunity Available)

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

4:30 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.

PREDICTION AND OPTIMIZATION OF STABILITY IN FREEZE-DRIED 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, PhD 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

PREDICTION AND OPTIMIZATION OF STABILITY IN FREEZE-DRIED FORMULATIONS (Cont.)

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 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.

9:20 Sponsored Presentation (Opportunity Available)

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

Advances in Drying Technologies for Complex Delivery Systems and Sensitive Biologics

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


2:00 PLENARY KEYNOTE PANEL

Click here for more details.

PepTalk Perspectives: Point-Counterpoint Discussions

Moderator:
Howard Levine, PhD, President and CEO, BioProcess Technology Consultants






Panelists:
Zhimei Du, PhD, Director, Bioprocess & Clinical Manufacturing, Merck






Lorenz Mayr, PhD, CTO, GE Healthcare Life Sciences




3:05 Refreshment Break in the Exhibit Hall with Poster Viewing

Excipients and Impurities in Pre-Filled Syringes and Freeze-Dried Formulations

4:00 Chairperson’s Remarks

Gregory A. Sacha, PhD, Senior Research Scientist, Baxter Healthcare Corporation

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 Protein Crowding in Solution, Frozen and Freeze-Dried States Studied by Small-Angle Neutron Scattering

Susan Krueger, PhD, NIST Center for Neutron Research, National Institute of Standards and Technology

Small-angle neutron scattering is uniquely qualified to study the structure of proteins in liquid and solid phases that are biotechnologically relevant. We have studied a model protein, lysozyme, in the liquid, water, ice and powder phases to determine its gross-structure, interparticle interactions and other properties. We also tested the effects of stabilizing excipients such as trehalose, glucose and sorbitol. Our results were compared to those from similar studies on antibodies.

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 The Effect of Co-Solvent Systems on the Drying Behavior of Common Excipients

Gregory A. Sacha, PhD, Senior Research Scientist, Baxter Healthcare Corporation

Many small molecules are poorly soluble in water and are often prepared in a co-solvent system prior to lyophilization. The co-solvent system may contain water and an organic solvent. This study examined the removal of the organic solvent from common excipients during primary drying using a residual gas analyzer. The drying behavior of amorphous and semi-crystalline formulations were examined as a function of organic solvent concentration.

6:05 - 7:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Lyophilization and Emerging Drying Technologies Conference

* The program is subject to change without notice, due to unforeseen reason.

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