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  Freezing and Drying Technologies Focus Group
 
Section Affiliations

Quality by Design as Applied to the Development and Manufacturing of a Lyophilized Product


This technology is very commonly used to enhance solubility and stability of conventional and biomolecules. There are several applications of these and continue to grow. Currently there is no forum where it is discussed and updated. It will benefit scientists or academicians who are working on proteins or conventional small molecules and looking various methods to store, solubilize and create dry dosage forms as lyophilized for sub-cutaneous/IV or spray freeze dried microspheres or powder for pulmonary delivery or solid dosage form for oral delivery. It will benefit anyone who involves drying at any stage of product development. Selection of right processing method is critical for successful development of a drug product. There are several different ways to remove water, but the method of choice depends on the formulation, route of delivery as well as the stability of the API. Most commonly used drying methods are – freeze-drying, spray drying, spray-freeze drying, foam drying, supercritical fluid drying and cryopreservation. Each of these techniques has its own advantages and disadvantages. All of these techniques are currently used throughout pharmaceutical and biotech industry to manufacture drug products and their application continues to grow. There is plethora of challenges associated with these drying technologies in terms of formulation, process development and ultimately scale up. Unfortunately, there is no forum where information on these drying techniques is discussed and updated. This focus group will benefit scientists, from both industry and academia, who are working on proteins or conventional small molecules and looking at various methods to improve stability, increase solubility and create dry dosage forms. This can be a freeze-dried product for sub-cutaneous/IV delivery or spray freeze dried microspheres or controlled particle size powder for pulmonary delivery or solid dosage form for oral delivery.

2008-2009 Goals and Objectives

  • Establish a core group of interested scientists throughout industry and academia to explore diverse areas of drying technologies (Freeze-drying, Spray drying, Vacuum drying, Foam drying, Spray Freeze Drying, Super Critical Fluid Drying, Cryopreservation);
  • Provide a forum to discuss scientific and technical issues related to drying technologies and also exchange experiences, ideas and information;
  • Define technical issues related to drying technologies (process vs. formulation vs. scale-up);
  • Organize quality programs for the AAPS Annual Meeting and to conduct workshops, symposia and round tables on current trends in drying pharmaceutical/biotech drug products.


JOIN THE Freezing and Drying Technologies FOCUS GROUP

To join the Freezing and Drying Technologies Focus Group, click here.

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  Leadership

Chair
Dr. Feroz Jameel
Amgen
Thousand Oaks, CA



Steering Committee Member
Ahmad M. Abdul-Fattah

Newbury Park, CA UNITED STATES



Steering Committee Member
Bakul S. Bhatnagar
University of Minnesota
Minneapolis, MN United States



Steering Committee Member
Sampath Krishnan
Amgen, Inc.
Thousand Oaks, CA United States



Steering Committee Member
Mr. Sajal Manubhai Patel
University of ConnecticutPharmaceutics/Freeze-Drying
Storrs Mansfield, CT UNITED STATES




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