PepTalk 2017
PepTalk 2017
Archived Content

Pipeline 1 and Pipeline 5 Header 

Sixth Annual
Lyophilization and Emerging Drying Technologies
Formulation, Cycle Development and Optimization, Regulatory Compliance, Validation, and Scale-Up
January 23-24, 2013 


Day 1| Day 2 | Download Pipeline 1 Brochure | Download Formulation and Packaging Flyer 


7:15 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


Advance/Alternative Drying Technology 

8:15 Chairperson’s Remarks

Taylor N. Thompson, President, Millrock Technology

8:20 Spray-Dried Biopharmaceutical Powders for Drug Substance Bulk Storage Application

Mayumi Bowen, Ph.D., Senior Engineer, Pharmaceutical Processing Technology Development, Genentech, Inc.

Dry powder-based active pharmaceutical ingredients offer advantages over liquid bulk in bio-processing due to their ability to overcome technical and economical issues such as shipping and storage costs. This talk will provide an overview of powder-based biopharmaceutical drug preparation by spray drying technology and how spray dryer designs and sample formulations impact the spray drying process performance for powder preparation of multiple monoclonal antibody molecules, focusing on powder collection yield, water contents, reconstitution time and stability of the spray dried mAbs.

8:50 Simulations of Vapor Flow in a Freeze-Drying Product Chamber toward Predicting Batch Uniformity

Arnab Ganguly, Graduate Research Assistant, Aeronautics & Astronautics, Purdue University

The current work focuses on developing and validating high-fidelity 3D models of the primary-drying process. Batch non-uniformities arising from chamber design and process parameters for both ice-slab testing and vial batches will be presented. The model will include about 2,000 vials placed on 3 shelves of a laboratory scale dryer. Difference in sublimation rates due to the vial location on a shelf and across shelves will be compared. The results will be put in perspective of how these variations scale with dryer size and sublimation rates.

9:20 New Process Technologies for Fast, Continuous Freeze Drying

Gerhard Winter, Ph.D., University Professor, Pharmacy, Ludwig Maximilian University of Munich

Technologies that speed up the time consuming freeze drying process are reviewed and several novel approaches are presented and critically assessed. Moving granule beds are a potential solution for the inadequate heat and mass transfer limiting most of the traditional freeze drying processes. Relevant model formulations are used to evaluate retention of protein stability after performing such novel drying processes.

9:50 Selected Poster Presentation: Controlled Nucleation: The Impact of Nucleation Method and Freezing Temperature on the Process and Properties of Freeze Dried Sample

Vamsi Mudhivarthi, Ph.D., Postdoctoral Fellow, Pharmaceutical Sciences, University of Connecticut

10:05 Coffee Break in the Exhibit Hall with Poster Awards


Practical Considerations and Case Studies 

10:45 Investigating Amino Acids as Stabilizing Additives in Lyophilized rHSA/Sucrose Formulations

Kelly Forney-Stevens, Graduate Student, Pharmaceutical Sciences, University of Connecticut

This presentation evaluated the effects of amino acids at several concentrations on the stability of lyophilized protein formulations and the relationship between increased storage stability and individual amino acid properties. The addition of twelve amino acids to a model lyophilized protein formulation reduced the amount of aggregation and significantly improved its storage stability. There appears to be a large range of stabilizing amounts, with no clear optimal minimum for the amino acids.

11:15 Lyophilization of Saccharide and Salt Containing Systems in Bottles: Collapse, Crystallization, and Implications

Bakul Bhatnagar, Ph.D., Principal Scientist, Formulation & Process Development, PhRD, Pfizer, Inc. 

While most pharmaceuticals are lyophilized in glass vials, there have been limited reports of freeze-drying in unconventional container-closure systems (for example, dual chamber syringes). This presentation will focus on our experiences at freeze-drying of sucrose – sodium chloride containing formulations (shell frozen material) in 1 liter glass bottles. Experiments were performed in a laboratory scale dryer in both vials and bottles under a variety of processing conditions (ranging from conservative to aggressive) to influence drying behavior, solute phase behavior, cake appearance, moisture content, and reconstitution time. Results from these studies and their potential implications will be discussed. Specifics of heat and mass transfer in 1 liter bottles will also be presented.

11:45 Water Clusters in Freeze-Concentrated Solutions and Dried Materials: Implications for Processing and Stability

Evgenyi Shalaev, Ph.D., Research Investigator, Allergan

While there is a wealth of empirical data on water-involved phase transformations during freeze-drying, and on impact of water on stability of various systems, fundamental understanding of water role is still lacking. The presentation deals with structural aspects of water and amorphous systems, in particular understanding of homogeneous water distribution vs clustering. The presentation combines a critical analysis of the literature with recent studies of model water-sugar systems.

12:15 pm Close of Morning Session

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:30 End of Conference

Day 1| Day 2 | Download Pipeline 1 Brochure | Download Formulation and Packaging Flyer