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2014 Archived Content

Cambridge Healthtech Institute’s Seventh Annual
Lyophilization and Emerging Drying Technologies
Formulation Development, Process Optimization, Validation and Regulatory Compliance
January 15-16, 2014

Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

THURSDAY, JANUARY 16

7:15 am Conference Registration

7:30 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


QBD In Lyophilization Process Development and Scale-Up 

8:30 Chairperson’s Remarks

Jeffrey Breit, Ph.D., Director, Pharmaceutical, Bend Research

8:35 FEATURED PRESENTATION

QbD in Freeze Drying Process Development: Construction of the Primary Drying Design Space

Steven L. Nail, Ph.D., Senior Baxter Research Scientist, Pharmaceutical Research & Development, Baxter Healthcare Corp.

Knowledge space, design space, and control space are defined, with emphasis on construction of the design space as a plot of sublimation rate vs. chamber pressure, with isotherms for a series of shelf temperatures and a series of product temperatures. This approach includes edges of failure, which are determined by 1) the upper product temperature limit during primary drying, and 2) equipment capability. Advantages and limitations of this approach, as well as applied research needs to further develop this design space approach, are discussed.

9:05 The Effect of Natural Variation on Freeze-Drying Design Space: Determining the Variation in Heat Transfer and Ice Nucleation Temperature on the Distribution of Product Temperatures and Drying Times within a Batch

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

Freeze-dried products have different temperature histories from vial to vial due to variation in heat transfer to the vials. The natural distribution of ice nucleation temperatures causes additional variation in temperature histories of product within a single freeze-dried batch. The variation can be used to predict the % of product exceeding a critical temperature with sensitivity to six sigma. Design space for various levels of defects can be constructed.

9:35 Selected Oral Poster Presentation: Evaluation of Drying Stabilization on Attenuated Enveloped Viral Vaccine Candidate

Lillian Li, Ph.D., Scientist, Formulation and Stability Platform, Bio-Process R&D, Sanofi Pasteur Canada

Drying technologies are commonly used to stabilize vaccine antigens or bio-pharmaceutical active ingredients in a solid state by removing water from aqueous formulation, where the degradative reactions are caused. Three drying technologies - conventional freeze dry (FD), spray freeze dry (SFD) and conventional spray dry (SD) are compared in our study using attenuated enveloped viral vaccine candidate as a model. Product physico-chemical characterization, microstructure, viral morphology, process yield and accelerated stability are compared.

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

Reconstitution Of Lyophilized Proteins: Case Studies 

10:50 Insights into the Reconstitution Behavior of Highly Concentrated Lyophilized Proteins

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

While a short reconstitution time is a key desirable attribute of a lyophilized product, long reconstitution times are observed for highly concentrated lyophilized proteins. Empirical approaches involving alteration of formulation variables, processing variables, reconstitution diluent, and reconstitution method(s) have been employed to shorten reconstitution times in the lyophilization literature. Data from systematic studies designed to investigate the effect of formulation and processing variables on wetting and hydration during reconstitution will be presented.

11:20 Mitigating the Challenge of Slow Reconstitution of High Concentration Protein Formulations

Wenjin Cao, Ph.D., Senior Scientist, Amgen, Inc.

Long reconstitution times are typically experienced with a lyophilized high concentration protein drug product, which can limit practical usage and commercial marketability of the product. This talk discusses a systematic approach on achieving reasonable reconstitution times of a high concentration lyophilized protein drug product. Many strategies have been shown to provide nominal improvement in reconstitution times, such as adding wetting agents in the diluents, incorporating high annealing steps in the lyophilization cycle and reconstituting under vacuum.  The reconstitution strategy of reduced diluent volume, however, has enabled significant decrease in reconstitution time (4-7 fold) of lyophilized high protein concentration formulations.

11:50 Sponsored Presentation (Opportunity Available)

12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:45 Close of Conference



Day 1 | Day 2 | Download Development Brochure | Speaker Biographies