Welcome to the LTI Library.  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 podium presentations, poster presentations, and publications/white papers authored by our staff which have been presented to the pharmaceutical community, professional organizations, and industry events within the United States and internationally.

 

 

Presentations

Posters

Publications/Technical Briefs

Press Releases

• Advances in Lyophilization: Systems and Facility Design (PDA)

• 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)

• 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)

 

 

  • Combining Nucleation Technology and Aseptic Processing:  The Impact of ControLyo™ on the Viability and Performance of Process Simulation Media Fills
  • Comparative Methods of Measurement and the Effect of Reduced Pressure on Seal Integrity for Lyophilized Products (PDA)
  • Contributing Factors to Lyophilizer Shelf Edge Effect and its Impact on Heat Transfer to the Product (AAPS)
  • Effect of Amorphous and Crystalline Solutes on the Low Temperature Crystallization of Proline (AAPS)
  • Effect on Container/Closure, Solute and Processing Parameters on Relative Rates of Sublimation During Primary Drying (CPPR Conference on Freeze Drying of Pharmaceuticals and Biologicals)
  • Effects of the Vial on Sublimation Rates w/ Ulfik, The Virtis Company(PDA)
  • Evaluating Lyophilized Product Appearance in a Laboratory Setting (CHI PepTalk)
  • Evaluating the Impact of Controlled Nucleation on Lyophilized Product Attributes and Processing Characteristics in an Aseptic Environment (CHI PepTalk)
  • Evaluating the Impact of Controlled Nucleation on Processing Bulk Lyophilized Material (CHI PepTalk)
  • Identification of Glass Vial Features Infuencing Heat Transfer as Measured by Sublimation Rate Using a Placket Burman Design w/ Asselta, Comar (CPPR Conference on Freeze Drying of Pharmaceuticals and Biologicals)
  • Impact of Lyophilizer Vacuum Pump Capacity and Gas Bleed Port Location on the Sublimation of Ice (AAPS)
  • Impact of Variable on Sublimation Rate Study Design (AAPS)
  • Importance of Identifying TPPs and Establishing CQAs for a Lyophilized Parenteral (PDA)
  • Influence of Vial Construction and Material on Uniformity of Product Temperature During Freezing and Freeze Drying of Model Product Formulations w/ The West Company (PDA)
  • Lyophilization in Plastic vs. Glass Syringes and Cartridges (CHI PepTalk)
  • Lyophilization Process Evaluation in Dual Chamber Cartridge Dosage Forms for Achieving Preferred Product Presentation and Batch Uniformity
  • Lyophilization Process Evaluation in Various Dual Chamber Cartridge Dosage Forms for Production Flexibility (PDA)
  • A Method for Combatting Temperature Non-Uniformity within the Lyophilizer...and Win (AAPS)
  • Methods for Evaluating the Variation in Heat Transfer for Tubing Vials (PDA)
  • Method for Evaluating Lyophilized Product in a Laboratory Setting (PDA)
  • Physical Strength of Materials for Pharmaceutical Vials and Prevention of Vial Breakage During Freezing and Freeze Drying w/ The West Company (PDA)
  • Process Validation for Lyophilized Drug Products:  Developing a Program for Continued Process Verification (1st Year of Data) (PDA)
  • Process Validation for Lyophilized Drug Products:  Developing a Program for Continued Process Verification (2nd Year of Data) (AAPS)
  • Quality Metrics for Contract Clinical Supply Operations (PDA)
  • Quality Systems for Contract Clinical Supply Operations:  Using Risk Analysis to Meet Global Requirements (AAPS)
  • Understanding the Performance of a Lyophilizer Through Shelf Temperature Mapping Studies:  Improving Technology Transfer Results (PDA)
  • Vials and Prevention of Vial Breakage During Freezing and Freeze Drying w/ The West Company (PDA)

 

 

• Methods for Measuring Shelf Temperature Uniformity in a Lyophilizer  Dutill, T.; Sunderland, W.

• Application of Low Temperature Thermal Analysis in Characterizing Lyophilized Products  Bosch, Amy

• Assessing The Quality of Lyophilized Parenterals  Daukas, L.A.; Trappler, E  (Pharmaceutical & Cosmetic Quality)

• Assurance Batch Uniformity for Freeze-Dried Products Trappler, E. (Pharmaceutical Manufacturing)

• Comparative Methods for Integrity Testing Vials Sealed at Reduced Pressure for Lyophilies Daukas, L.A., Trappler, E.

   (PDA Journal of Pharmaceutical Science and Technology)

• Explanation of Low Temperature Thermal Analysis Bosch, A.

• Freeze Drying, Scale-Up Considerations Trappler, E. (Encyclopedia of Pharmaceutical Technology)

• The Influence of Bottomed Trays on Sublimation Rates  Trappler, E.; Sunderland, W.; Gentilcore, T.F.

   (Pharmaceutical Engineering)

• The Influence of Lyophilization on the Polymorphic Behavior of Mannitol Trappler, E.;   Cannon, A.

   (PDA Journal of Pharmaceutical Science and Technology)

• Low-Temperature Thermal Analyses are Key to Formulation Design  Thomas, M.; Cannon, A.J.

   (Pharmaceutical Technology)

• Lyophilization Trappler, E. (Aseptic Pharmaceutical Manufacturing II)

• Lyophilization:  Equipment Trappler, E. (Lyophilization of Biopharmaceuticals)

• Scale-Up Strategy for a Lyophilization Process Trappler, E. (American Pharmaceutical Review)

• Selecting and Qualifying an Alternate Heat Transfer Fluid for Lyophilizers: A Case Study Trappler, E.; Manwaring,T.

   (ISPE Pharmaceutical Engineering)

• Strategies in Development of Lyophilized Parenterals Trappler, E. (American Pharmaceutical Review)

• Validation of Lyophilization Trappler, E. (Validation of Pharmaceutical Processes: Sterile Products 2nd Edition)

• Validation of Lyophilization Trappler, E. (Validation of Pharmaceutical Processes: Sterile Products 3rd Edition)

• Validation of Lyophilization:  Equipment and Process “Freeze Dryers and Heat and Mass Transfer” Trappler, E.

   (Lyophilization of Biopharmaceuticals)

• Validation of Lyophilization: The Key to Reproducibility and High-Quality Product  Trappler, E. (IVD Technology)

 

 

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