This meeting covers the latest trends and challenges in lyophilization and emerging drying technologies. It features in-depth case studies and discussion on developing a scientifically sound formulation, process optimization, vaccine and biologics freeze/thaw and formulation challenges, strategies for scale-up from R&D to production, and selection of container/closure systems.
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THURSDAY, JANUARY 12
1:00 pm Conference Registration
1:45 Chairperson's Remarks
Robin Bogner, R.Ph., PH.D., Associate Professor, Department of Pharmaceutical Sciences, University of Connecticut
» KEYNOTE PRESENTATION
1:50 The Scientific Basis of QbD: Developing a Scientifically Sound Formulation and Optimizing the Lyophilization Process
Michael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut
2:35 The Importance of Controlling Nucleation Temperature during the Freeze Step
Mark Shon, Vice President, SP Scientific
The benefits of controlling nucleation are now being well described following the introduction of the Praxair ControLyo technology. The combination of ControLyo and MTM on the SPScientific Lyostar have for the first time allowed researchers to study the impact of controlled nucleation on critical process parameters such as dry layer resistance, product temperature and sublimation rate. Results of this technology are presented, including significant reduction in primary drying times.
2:50 Non-Invasive In-Line Monitoring of Product Temperature During Lyophilization Using Tunable Diode Laser Absorption Spectroscopy (TDLAS)
Puneet Sharma, Ph.D., Postdoctoral Fellow, Pharmaceutical Sciences, University of Connecticut
This talk will focus on a new methodology, based on heat and mass transfer principles in conjunction with TDLAS determined mass flow rate, for estimation of product temperature during lyophilization on a lab and a pilot scale freeze dryer. The TDLAS product temperature is compared with the product temperature measured using Thermocouples during primary drying. Throughout the study, a good agreement between the TDLAS and thermocouple product temperature has been observed. In addition, the new methodology enables the user to predict the number of vials getting dried as a function of time.
3:20 Poster Highlight
3:35 Neworking Refreshment Break in the Exhibit Hall with Poster Viewing
4:30 New System for the Generation and Delivery of High Concentrations of Respirable Aerosols of Biologics and Large Labile Molecules
Donovan Yeates, Ph.D., CEO, Research & Development, KAER Biotherapeutics
Respiratory delivery of tens of milligrams of large labile molecule aerosols in a short time presents formidable barriers. To meet this challenge, a new class of aerosol delivery system was developed. SUPRAER generates a large liquid aerosol from an aqueous solution or suspension of the active agent. These large droplets are rapidly evaporated to form a dry respirable aerosol. This resultant aerosol is concentrated using a virtual impactor. SUPRAER employs single pass low shear nozzles and is ideal for laboratory generation of biologics and large labile molecules.
5:00 Optical Coherence Tomography (OCT) Based Freeze Drying Microscopy for Collapse Temperature Determination
Kristyn Greco, Ph.D., Postdoctoral Fellow, Pharmaceutics, University of Connecticut
The collapse temperature of an amorphous or partially amorphous formulation is an important parameter in the development of a lyophilization cycle. A single vial freeze dryer equipped with an optical coherence tomography based freeze drying microscope (OCT-FDM) has been developed for the accurate measurement of collapse temperature. This technology provides 3D product structural information during freeze drying and product collapse temperature data in a product/container of practical significance, a vial that is used during laboratory and manufacturing scale freeze drying. The OCT imaging system enables the accurate determination of product collapse temperature in a vial to improve the development of optimal freeze drying cycles.
5:30 Fast-Dissolving Tablet Vaccines for Enteric and Other Mucosal Pathogens Made by Lyophilization
Dexiang Chen, Ph.D., Senior Technical Officer and Portfolio Leader for Vaccine Formulation, Technology Solutions Global Program, PATH
Formulating live attenuated vaccines, particularly those for oral delivery to infants, is technically challenging in terms of manufacturability, the degree of stability improvement, and the procedures required for preparing the formulation at point of use. Temperature stabilization has been particularly challenging for live attenuated enteric vaccines. In this study, PATH investigated the fast-dissolving tablet (FDT) as a platform technology for formulating oral vaccines for infant immunization. Made using a standard lyophilization process, the FDTs are packaged in a foil blister—furthering their potential as an inexpensive, scalable, and easy-to-use product presentation for enteric vaccines. The formulation to produce an FDT of a live-attenuated Escherichia coli vaccine and its characteristics will be discussed.
6:00 Close of Day
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Links to Companion Meetings
Optimizing Biologics Formulation Development
Protein Aggregation and Emerging Analytical Tools