Lyophilization Technology

Presentations

Our Scientific Advisory Board oversees our internal research activities and provides guidance to our scientific staff. While engaging in continued research for greater knowledge and to promote technological developments, our goal is to also provide you a better understanding by publishing and presenting our discoveries for educational purposes. Below is a list of LTI's presentations authored by our staff which have been presented to the pharmaceutical community, professional organizations, and industry events within the United States and internationally. Should you be interested in reviewing a copy of any of the items listed, please contact us and we will be happy to assist you. If you would like to receive insider announcements of our latest research presented to the industry you may subscribe to receive our "In the Know" newsletter.

  • Advances in Lyophilization: Systems and Facility Design (PDA)
  • Approaches to Using Statistical Process Control Techniques for Continuous Monitoring of the Lyophilization Process (ISLFD International)
  • Challenges and Opportunities of Contract Development and Manufacture for Lyophilized Drug Products (CHI PepTalk)
  • Clinical vs. Commercial Manufacturing- Consideration for Lyophilized Drug Products (PharmaEd)
  • Combining Nucleation Technology and Aseptic Processing: The Impact of ControLyo™ on the Viability and Performance of Process Simulation Media Fills (PharmaEd)
  • Compliance Considerations for Legacy Lyophilized Products- Tales of Forensic Development (BOCEPS)
  • Contemporary Lyophilization Science, Technology and Regulations (PTEK U)
  • Correlation of Physical Attributes to Product Characterization of Lyophilized Drug Product (PDA)
  • Creation of Design Space for Established Lyophilized Drug Products (PDA)
  • Current Compliance Considerations for Lyophilization Process Development (AAPS)
  • Current Lyophilization Initiatives: Integrating Good Science and Regulatory Perspectives (PDA New England Chapter)
  • Current Trends in Design Qualification of Clinical Trial Supply Manufacturing Facilities (PDA)
  • Design and Maintenance of Quality Systems for Contract Clinical Supply Operations (PDA)
  • Development Approaches and Objectives in Preparation for Manufacturing Lyophilized Clinical Materials (CHI PepTalk)
  • Development of a Lyophilization Cycle - Factors to Consider: A Case Study (AAPS)
  • Effect of Amorphous and Crystalline Solutes on the Low Temperature Crystallization of Proline in Aqueous Systems (AAPS)
  • Effect of Stopper Design on Freeze Drying (w/ Smith & Currey, The West Co. - PDA)
  • Effect of Vial Construction on Performance and Product Temperature During Freezing and Freeze Drying (Freeze Drying of Pharmaceuticals and Biologicals- CPPR)
  • Establishing Design Space for Lyophilized Drug Products (Interphex)
  • Evaluation of Dried Product Uniformity for Bulk Lyophilized Materials (PDA)
  • From Bench to Supply - Considerations for Development and Manufacture of Lyophilized Drug Products (PARCS)
  • Impact of Lyophilizer Characteristics on Process Design and Scale-Up of Lyophilized Drug Products (CHI PepTalk)
  • Impact of Variables on Sublimation Rate Study Design (AAPS)
  • Influence of Formulation Design on Lyophilization Processing Parameters (BioPharm)
  • Influences of Formulation Design on the Behavior of Human Growth Hormone during Lyophilization: A Case Study (PDA)
  • The Influence of Processing Conditions and Formulation Attributes on the Destiny of Visible Contaminating Particles in Lyophilized Cakes (CHI Protein Conference)
  • An Investigation into the Influence of Formulation Characteristics on the Density if Visible Contaminating Particles in Lyophilized Cakes (w/ J. Knapp - PDA)
  • An Investigation into the Influence of Freezing Rate on the Density of Visible Contaminating Particles in Lyophilized Cakes (PDA)
  • Lyophilized Clinical Trial Materials: Technical and Regulatory Considerations (PDA)
  • Lyophilization Overview (ISPE)
  • Lyophilization Process Development: A Case Study (AAPS)
  • Lyophilization Process Evaluation in Dual Chamber Cartridge Dosage Forms for Achieving Preferred Product Presentation and Batch Uniformity (AAPS)
  • Lyophilization Process Evaluation in Dual Chamber Cartridge Dosage Forms: A Customized Approach to Achieving a Preferred Product Presentation and Processing Flexibility (CHI PepTalk)
  • A Method to Combat Temperature Non-uniformity within the Lyophilizer Chamber... and Win (AAPS)
  • Operation and Maintenance of Lyophilizers (PharmTech)
  • Operational Qualification (SP Scientific LyoLearn)
  • Performance Characteristics of Ready-to-Use Dessicant Closures Day, Leslie; DeGrazio, F.L.; Drummond, J.L.; Hlobik, Tibor M.; Stokes, Jennifer R.; Trappler, Edward H. (PDA)
  • Process Monitoring Using Residual Gas Analysis (PDA)
  • Process Validation Part 1 (SP Scientific LyoLearn)
  • Process Validation Part 2 (SP Scientific LyoLearn)
  • Process Validation for Lyophilized Drug Products: Developing a Program for Continued Process Verification (DIA)
  • The Processing Conditions and Formulations Attributes on the Density of Visible Contaminating Particles in Lyophilized Cakes (CHI Protein Conference)
  • Quality Agreements: Defining the Business of Pharmaceutical Quality (PDA)
  • Quality Systems for Contract Clinical Supply Operations: Using Risk Analysis to Meet Global Requirements (AAPS)
  • Rationale for Cycle Development of Lyophilized Products (ISPE)
  • The Relevance of Leak Testing in the Assessment of Aseptic Processing (PDA)
  • A Risk-Based Approach Towards Inspection of Lyophilized Products (w/ J. Knapp - PDA)
  • Root Cause Analysis and Risk Assessment for Lyophilize Products (CHI, Lyophilization)
  • Scale-Up of Controlled Nucleation in an Aseptic Environment (Freeze Drying of Pharmaceuticals and Biologicals- CPPR)
  • Scaling up the Lyophilization Process (PharmTech)
  • Status of the PDA Validation of Lyophilization Task Force (PDA)
  • Supplier Qualification for Early Phase Clinical Supplies: 5 Essential Questions to Ask (PDA)
  • Techniques and Considerations in Evaluation of Dried Product Uniformity for Bulk Lyophilized Materials (PDA)
  • Techniques in Demonstrating Batch Uniformity for Lyophilized Products (PDA)
  • Understanding FDA Requirements for Lyophilized Products (PharmaEd)
  • Validation of Container/Closure Integrity for Vials Stoppered Under Vacuum (Freeze-Drying of Pharmaceuticals and Biologicals- CPPR)
  • Validation of Lyophilization (Academy of Pharmaceutical Sciences & Technology, Japan)
  • Validation of Lyophilization (MD&M)
  • Validation of Lyophilization and FDA Issues and Concerns (Pharm. Tech)
  • Validation of Paired Equipment: Freeze Drying (w/ Bender & Didas, Genentech - PDA)
  • Visual Inspection of Lyophilized Parenterals (w/ Knapp - PDA)
  • Water System Design, Control and Use in a Development and Clinical Manufacturing Operation - Use of Polymeric Material (PDA)