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Live Webinar on Lypolization

VIEWS: 6 PAGES: 3

									Live Webinar on : Lyophilization Process Development and Cycle Design –
Thursday 15 September 2011, 01:00 PM EST / 10:00 AM PDT (90 Minute)

                                         Description

                                         This seminar will cover the process and benefits of
                                         using an empirical approach to design an optimized
Get 15 % Discount as a early bird        lyophilization cycle. In the past, a “trial and error”
registrations. Use Promo Key :           approach was routinely used as the means of cycle
 CGO15                                   design, often resulting in products that were
                                         substandard or cycles that were prohibitively long and
                                         expensive.
Who will benefit

This webinar will provide valuable
assistance to those companies            By taking the time to characterize the thermal
involved in the handling of powders,     properties of each formulation and understanding how
lyophilized products, solid              to use this information correctly during each phase of
pharmaceutical dosage forms, and         cycle development, the process development scientist
dried foods.                             can ensure that a quality product meeting both
                                         chemical and physical quality specifications can be
         Quality Control Scientists.    produced in the shortest amount of time possible.
         Development Scientists.
         Production Management.
         Quality Assurance              Why should you attend:

                                         Optimized lyophilization cycle design can be an
Pricing                                  extremely difficult and daunting task for the scientist
                                         that is unskilled or under skilled in the process. This is
Live ( Single registration ) : $189.00   becoming even more prevalent as many of the
Group ( Max 10 Attendee): $499.00        molecules coming out of discovery are more complex,
                                         unstable, and require a very specific, multi component
                                         formulation to impart not only good chemical stability
     More Trainings                      and physical stability to the active ingredient, but also
                                         good physical stability to the dried solids themselves.
                                         Unfortunately, many of the molecules that are used to
                                         help stabilize the chemical and physical stability of the
                                         active ingredient, impart poor physical stability to the
                                         dried solids and can make lyophilization cycle design
                                         difficult. The development scientist who understands
                                         and can apply these principles, will be much better
                                         equipped to develop robust cycles that can be used to
                                         produce quality products consistently, in the shortest
amount of time possible, saving time and money.



This seminar will start out with an introduction to
thermal characterization including differential scanning
calorimetry (DSC) and freeze-dry microscopy (FDM)
and how the information gained from these techniques
can be used as the foundation for optimized cycle
design. Next, the seminar will discuss, in detail, the
process of designing the freezing, primary, annealing (if
used), and secondary drying protocols for the cycle. In
each case, the process will be broken down to
understand the correct choice of the different
controllable lyopohilizer parameters including shelf
temperature, chamber pressure, and hold times.



Also discussed, will be some of the specialized tools
that can be used to aid the development scientist in
cycle development including, the sample thief, the
Pirani gauge, and thermocouples..


Areas Covered in the Seminar:

      1. Thermal characterization including DSC and
         FDM.
      2. 2. Understanding the effects of working with
         crystalline vs. amorphous components.
      3. 3. The problem with working with a
         metastable glassy system and the use of
         annealing to correct this problem.
      4. 4. Determining optimal shelf temperatures
         for the freezing step.
      5. 5. Determining optimal shelf temperatures
         and chamber pressures for the primary
         drying step.
      6. 6. Determining optimal shelf temperatures
         and chamber pressures for the secondary
         drying step.
      7. 7. Characterization of the finished
         lyophilized product.




About Speaker:

J. Jeff Schwegman, Ph.D. is currently the founder and
              chief executive officer of AB BioTechnologies (www.ab-
              biotech.com) where he develops formulations,
              lyophilization cycles, determines residual moisture by
              Karl Fischer, and provides thermal characterization
              studies including freeze-dry microscopy and DSC.
              Additionally, Dr. Schwegman specializes in speaking
              and consulting in parenteral pre-formulation,
              formulation, analytical, and lyophilization of both small
              molecules and large biomolecules. He also holds
              patents and develops new technologies within the
              lyophilization field. Dr. Schwegman received his BS in
              Biochemistry from Indiana University in 1992 and
              began working at Cook Imaging in Bloomington
              Indiana, where he gained experience in analytical,
              formulation and process development. In 1999 he began
              graduate study in the Department of Industrial and
              Physical Pharmacy at Purdue University under the
              direction of Dr. Steve Nail, where his focus of research
              involved studying changes in the physical structure of
              biological molecules during lyophilization. Dr.
              Schwegman received his PhD from Purdue University
              in 2003, and returned to Bloomington where he worked
              at Baxter Pharmaceutical Solutions as a Research
              Scientist in the Pharmaceutical Development group. In
              November 2005, he left Baxter and formed
              BioConvergence LLC with 3 other founders which
              specialized in developing new formulations and
              manufacturing processes for parenteral products. In
              February 2008, he left BioConvergence, which has
              become a successful company, to form AB
              BioTechnologies. He is currently the course Director for
              a 3-day course called Lyophilization Technology which
              he teaches through the Center for Professional
              Innovation and Education. He routinely lectures around
              the world on formulation, stabilization and process
              development of lyophilized products..




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