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Cambridge Healthtech Institute’s 8th Annual 
Lyophilization and Emerging Drying Technologies
Formulation Development, Process Optimization, Validation
and Regulatory Compliance

January 21-22, 2015


This popular conference covers latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. The Lyophilization and Emerging Drying Technologies conference features in-depth case studies and discussion on developing scientifically sound formulation, process optimization for biologics and vaccines. It also presents cutting-edge research and case studies on freeze/thaw and formulation challenges, drying in cartridges, storage stability and strategies for scale-up from R&D scale to full production level, tech transfer and selection of container/closure systems.

We invite you to join colleagues in this discussion of the key challenges and solutions in lyophilization and other drying technologies, and see how experts like you are developing a scientifically sound formulation to deliver a safe and stable biologic drug product.


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Final Agenda 


TUESDAY, JANUARY 20

1:30 pm Conference Registration


BUZZ Sessions png

2:00 BuzZ Session A

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B



4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses More Details >> 



WEDNESDAY, JANUARY 21

7:30 am Conference Registration and Morning Coffee


Lyophilized Formulation Development and Protein Stability

8:15 Chairperson’s Opening Remarks

Gerhard Winter, Ph.D., Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen


Keynote Presentation

8:20 Neglected Factors in Stabilization of Proteins by Freeze Drying

Michael Pikal, Ph.D., Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut

Stability trends have traditionally been interpreted in terms of either native structure retention during the process or minimizing molecular mobility. While recent evidence does suggest that storage stability often correlates well with measures of “fast dynamics”, such as the amplitude of motion on a nanosecond time scale, correlations are not perfect. Here, we discuss two other factors that are often ignored, surface effects and coupling of the protein internal dynamics with dynamics of the matrix.


9:00 The Role of Physical Chemistry in Freeze Drying – From Product Characteristics to Process Performance

Timothy R. McCoy, MSc, Principal Scientist, Technical Development, Genzyme Ireland

The principles of physical chemistry are embedded in the process of freeze drying of pharmaceuticals. During this presentation, product characteristics such as the glass transition temperature of the freeze concentrate and the solid state, along with process characteristics such as sublimation rates and the vial heat transfer coefficient will be examined. Case studies will be used to demonstrate correlations between characteristics of the freeze dried solid state and finished product stability.

9:30 Minimize Protein Degradation during Lyophilization by Process and Formulation Design

Charlie (Xiaolin) Tang, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals, Inc.

A model protein was lyophilized. Protein degradation (aggregates formation) was observed after lyophilization. A method was developed to understand the stress to protein during different stages of lyophilization process including stages of freezing, annealing, primary drying and secondary drying. The specific lyophilization stages were identified to have the most stresses to cause protein degradation. By optimization of the freeze drying cycle and protein formulation, the protein degradation was minimized.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


Advances in Lyophilization Technology

10:50 In Silico Analysis Design of Freeze-Drying Systems and Processes

Alina A. Alexeenko, Ph.D., Assistant Professor, School of Aeronautics and Astronautics, Purdue University

This talk reviews recent advances in application of in silico methods for understanding and improving lyophilization. Computational simulations have been applied to vial- and batch-level heat and mass transfer as well as modeling of various elements of lyophilizers such as shelf uniformity, product chamber flows and condenser performance. The integration of such models into a system framework provides a new process analytical tool for more efficient and robust freeze-drying of bio-pharmaceuticals.

11:20 A Critical Eye on Controlled Nucleation in Freeze Drying of Protein Drugs

Gerhard Winter, Ph.D., Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen

Controlled nucleation (CN) has gained attention as a process step promising reduced drying time and improved batch homogeneity. Many vendors offer systems that can be attached to existing freeze dryers. The question remains how much positive effect on the product (protein) quality can really be achieved by CN, whether it is valuable for highly concentrated protein formulations and how its implementation from formulations research into production should be managed.

11:50 Application of Controlled Ice Nucleation for Lyophilization of a Low Glass Transition Temperature Solution

Graham Magill, Engineer I, Pharmaceutical Processing and Technology Development, Genentech, Inc. – A Member of the Roche Group

Here we will discuss the application of Praxair ControLyo controlled ice nucleation technology to optimize the lyophilization of a low glass transition temperature (Tg’), high fill volume product. The impact of processing parameters such as ice nucleation temperature and post-nucleation cooling ramp rate on cake microstructure will be discussed.

12:20 pm Effect of Nucleation Temperature on Protein Aggregation, Folding and Presence of Subvisible Particles

Mark Shon, MBA, Vice President, Technology Development, SP Scientific

Jeff Schwegman, Ph.D., CEO, AB Biotechnologies

Using new technologies for controlling nucleation temperature and measuring sub-visible particles and aggregation, it is now possible to investigate the impact on protein stability of minimizing super-cooling. In this study, nucleation was controlled at different temperatures. After completion of the lyophilization cycle, aggregation, protein conformation and sub-visible particle formation of a model protein were measured, immediately after lyophilization and at 15, 30, 60 and 90 days post lyophilization and were compared to a pre-lyophilization baseline.

12:50 Session Break

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own


Lyo Process Development: QbD, Scale-Up and Design Space

2:00 Chairperson’s Remarks

Mark Shon, MBA, Vice President, Technology Development, SP Scientific

2:05 Measurement of Vial Heat Transfer Coefficients: Nuances and Pitfalls

Robin Bogner, Ph.D., Associate Professor, School of Pharmacy, University of Connecticut

The design of a lyophilization cycle, its scale-up, and several PAT tools require input of a “vial heat transfer coefficient”, Kv. The classic equations for measurement of Kv (described in 1984) are applicable to a well-defined experimental protocol. Modification of the Kv measurement protocol requires revised equations to accurately calculate Kv. The use of accurate vs. inaccurate Kv in lyophilization design space and PAT will be compared.

2:30 Primary Drying Optimization Using a Three-Dimensional Design Space

Lindsay A. Wegiel, Ph.D., Research Associate III, Pharmaceutical R&D Baxter Healthcare Corporation

The current approach to primary drying optimization using a design space is two dimensional whereby the processing conditions are set throughout the primary drying cycle. However, the product is changing throughout primary drying with regards to the product resistance (Rp). This is a key component of the design space calculations and thus adding the third dimension of time to allow for the changes in Rp will allow for further optimization and shorter lyophilization cycle times.

2:55 Laboratory Measurement of Collapse Temperature Predictive of Collapse in Manufacturing Operations

Vamsi Mudhivarthi, Ph.D., Postdoctoral Fellow, School of Pharmacy, University of Connecticut

Traditionally, freeze drying microscopy has been used to estimate collapse temperature, but it has become apparent that such methodology is not necessarily predictive of collapse during freeze drying in commercial containers. Previous studies suggested that methodology based on “Optical Coherent Tomography”, or OCT, is predictive. Here we demonstrate the generality of this early observation and present a theoretical analysis that supports the experimental observations using OCT.

3:20 Lyophilization Process Design and Development using Quality by Design (QbD) Principles

Sajal M. Patel, Ph.D., Scientist, Formulation Sciences, Biopharmaceutical Development, MedImmune, Inc.

Lyophilization is a unit operation that is routinely used to stabilize an otherwise unstable molecule to achieve pharmaceutically acceptable shelf life. The lyophilization process is based on fundamental principles of heat and mass transfer, and the overall understanding of the impact of process parameters on product quality attributes has increased significantly over the past few decades. QbD aims at building quality within the process rather than monitoring offline at the end of the process. This presentation will describe application of QbD elements—risk assessment, process characterization, PAT (Process Analytical Tool) and Design Space—to design, develop and scale-up of the lyophilization process.

3:35 Sponsored Presentation (Opportunity Available)

4:05 Refreshment Break


4:25 Plenary Keynote Session

5:45-7:00 Reception in the Exhibit Hall with Poster Viewing



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