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2014 Archived Content

Cambridge Healthtech Institute’s Fourth Annual
Protein-Device Combinations
Integrating Protein Formulations with Parenteral and Alternative Administration Devices
January 15-16, 2014



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THURSDAY, JANUARY 16

7:15 am Conference Registration

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


Integrating Formulation and Device: Injections, Syringes and High Volume Delivery Devices 

8:30 Chairperson’s Remarks

William J. Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc.


Featured Presentation

8:35 High Volume Delivery Devices

Samir MitragotriSamir Mitragotri, Ph.D., Professor, Chemical Engineering, Founding Director, Center for Bioengineering, University of California, Santa Barbara

My talk will focus on needle-free jet injectors for high volume delivery. Needle-free injectors can deliver large liquid volumes into subcutaneous space through the use of high velocity liquid jet. I will discuss the current status and future challenges in jet injection devices. Mechanisms and applications of jet injections will be discussed.

9:05 Large Volume Bolus Injectors for Subcutaneous Delivery

Bill LambertWilliam J. Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc.

Protein and peptide products have led to significant growth of handheld SC delivery devices such as pens and autoinjectors. However many products, antibodies in particular, often require volumes exceeding 1 mL. This presentation will review the evolution of LV-BIs and will discuss points to consider in the development of these combination products.

9:35 Selected Oral Poster Presentation: Impact of Water Resorption on Manometric Product Temperature Measurement of Amorphous Solids

Lokesh Kumar, Post Doctoral Fellow, Department of Pharmaceutical Sciences, University of Connecticut

Manometric product temperature measurement is based on vapor pressure rise in the drying chamber for a short period (~25 sec), during isolation from the condenser by valve closure. This measurement behaves differently for crystalline vs amorphous solids, with significant product temperature error for amorphous solids, especially at high concentrations. This presentation will discuss the impact of water resorption by amorphous solids on manometric product temperature measurement, with special emphasis to protein formulations.

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