Mary T. am Ende, PHD, is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years' experience in drug product formulation, process development and computational modeling. David J. am Ende, PHD, is President of Nalas Engineering Services, Inc. Previously, he was Research Fellow at Pfizer Inc. in the Chemical Research & Development department. He has over 25 years experience in chemical process development.

Select Guide Rating

• List of Contributors ixPreface xvUnit Conversions xviiPart I Introduction 11 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3David J. am Ende and Mary T. am EndePart II Drug Product Design, Development, and Modeling 192 Design of Solid Dosage Formulations 21Kevin J. Bittorf, Tapan Sanghvi, and Jeffrey P. Katstra3 Powder Process Challenges and Solutions 53Thomas Baxter and James Prescott4 Design and Scale-up of Dry Granulation Processes 81Howard J. Stamato and Omar L. Sprockel5 Model-based Development of Roller Compaction Processes 119Gavin Reynolds6 Wet Granulation Processes 147Karen P. Hapgood and James D. Litster7 Toward a Generic Model for Twin-screw Wet Granulation 173Daan Van Hauwermeiren, Maxim Verstraeten, Michaël Ghijs, Kai Lee, Neil Turnbull, Mary T. am Ende, Pankaj Doshi, David Wilsdon, Thomas De Beer, and Ingmar Nopens8 Modeling a Dosator Capsule Filling Process for Hard-shell Capsules 187Peter Loidolt, Eva Faulhammer, and Johannes G. Khinast9 Powder Compaction: Process Design and Understanding 203David Wilson, Ron Roberts, and John Blyth10 Punch Sticking: Factors and Solutions 227Daryl M. Simmons11 Spray Atomization Modeling for Tablet Film Coating Processes 245Alfred Berchielli, Pankaj Doshi, Alberto Aliseda, and Juan C. Lasheras12 Spray Drying and Amorphous Dispersions 267Kristin J.M. Ploeger, Pavithra Sundararajan, Pedro C. Valente, Kenneth J. Rosenberg, João G. Henriques, and Paige Adack13 The Freeze Drying Process: The Use of Mathematical Modeling in Process Design, Understanding, and Scale-up 293Venkat Koganti, Sumit Luthra, and Michael J. Pikal14 Sterilization Processes in the Pharmaceutical Industry 311Piero M. Armenante and Otute Akiti15 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms 381Avinash G. Thombre, Xiao Yu (Shirley) Wu, and Mary T. am Ende16 Process Design and Development for Novel Pharmaceutical Dosage Forms 409Leah Appel, Joshua Shockey, Matthew Shaffer, and Jennifer Chu17 Multiscale Modeling of a Pharmaceutical Fluid Bed Coating Process Using CFD/DEM and Population Balance Models to Predict Coating Uniformity 419Avik Sarkar, Dalibor Jajcevic, Peter Böhling, Peter Toson, Matej Zadravec, Brian Shoemaker, Pankaj Doshi, Johannes Khinast, and Mary T. am Ende18 Process Design of Topical Semisolids: Application of Fundamental Concepts in Pharmaceutical Engineering to PEG Ointment Development 451Amanda Samuel, Thean Yeoh, Rolf Larsen, and Avik Sarkar19 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions 469Luke Schenck, Gregory M. Troup, Mike Lowinger, Li Li, and Craig Mckelvey20 Drug Product Process Modeling 489Mary T. am Ende, William Ketterhagen, Andrew Prpich, Pankaj Doshi, Salvador García-Muñoz, and Rahul BharadwajhPart III Continuous Manufacturing 52721 Continuous Manufacturing in Secondary Production 529Martin Warman22 Continuous Direct Compression Using Portable Continuous Miniature Modular & Manufacturing (PCM&M) 547Daniel O. Blackwood, Alexandre Bonnassieux, and Giuseppe Cogoni23 Process Control Levels for Continuous Pharmaceutical Tablet Manufacturing 561Niels Nicolaï, Ingmar Nopens, Maxim Verstraeten, and Thomas De BeerPart IV Applied Statistics and Regulatory Environment 58524 Multivariate Analysis for Pharmaceutical and Medical Device Development 587Frederick H. Long25 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization 601Theodora Kourti26 Quality by Design: Pilot to Reality-The Honeymoon Phase to the Stormy Years 631Mary T. am Ende and Christine B. SeymourIndex 645

Mary T. am Ende, PHD, is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years' experience in drug product formulation, process development and computational modeling. David J. am Ende, PHD, is President of Nalas Engineering Services, Inc. Previously, he was Research Fellow at Pfizer Inc. in the Chemical Research & Development department. He has over 25 years experience in chemical process development.

Select Guide Rating

• List of Contributors ixPreface xvUnit Conversions xviiPart I Introduction 11 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3David J. am Ende and Mary T. am EndePart II Drug Product Design, Development, and Modeling 192 Design of Solid Dosage Formulations 21Kevin J. Bittorf, Tapan Sanghvi, and Jeffrey P. Katstra3 Powder Process Challenges and Solutions 53Thomas Baxter and James Prescott4 Design and Scale-up of Dry Granulation Processes 81Howard J. Stamato and Omar L. Sprockel5 Model-based Development of Roller Compaction Processes 119Gavin Reynolds6 Wet Granulation Processes 147Karen P. Hapgood and James D. Litster7 Toward a Generic Model for Twin-screw Wet Granulation 173Daan Van Hauwermeiren, Maxim Verstraeten, Michaël Ghijs, Kai Lee, Neil Turnbull, Mary T. am Ende, Pankaj Doshi, David Wilsdon, Thomas De Beer, and Ingmar Nopens8 Modeling a Dosator Capsule Filling Process for Hard-shell Capsules 187Peter Loidolt, Eva Faulhammer, and Johannes G. Khinast9 Powder Compaction: Process Design and Understanding 203David Wilson, Ron Roberts, and John Blyth10 Punch Sticking: Factors and Solutions 227Daryl M. Simmons11 Spray Atomization Modeling for Tablet Film Coating Processes 245Alfred Berchielli, Pankaj Doshi, Alberto Aliseda, and Juan C. Lasheras12 Spray Drying and Amorphous Dispersions 267Kristin J.M. Ploeger, Pavithra Sundararajan, Pedro C. Valente, Kenneth J. Rosenberg, João G. Henriques, and Paige Adack13 The Freeze Drying Process: The Use of Mathematical Modeling in Process Design, Understanding, and Scale-up 293Venkat Koganti, Sumit Luthra, and Michael J. Pikal14 Sterilization Processes in the Pharmaceutical Industry 311Piero M. Armenante and Otute Akiti15 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms 381Avinash G. Thombre, Xiao Yu (Shirley) Wu, and Mary T. am Ende16 Process Design and Development for Novel Pharmaceutical Dosage Forms 409Leah Appel, Joshua Shockey, Matthew Shaffer, and Jennifer Chu17 Multiscale Modeling of a Pharmaceutical Fluid Bed Coating Process Using CFD/DEM and Population Balance Models to Predict Coating Uniformity 419Avik Sarkar, Dalibor Jajcevic, Peter Böhling, Peter Toson, Matej Zadravec, Brian Shoemaker, Pankaj Doshi, Johannes Khinast, and Mary T. am Ende18 Process Design of Topical Semisolids: Application of Fundamental Concepts in Pharmaceutical Engineering to PEG Ointment Development 451Amanda Samuel, Thean Yeoh, Rolf Larsen, and Avik Sarkar19 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions 469Luke Schenck, Gregory M. Troup, Mike Lowinger, Li Li, and Craig Mckelvey20 Drug Product Process Modeling 489Mary T. am Ende, William Ketterhagen, Andrew Prpich, Pankaj Doshi, Salvador García-Muñoz, and Rahul BharadwajhPart III Continuous Manufacturing 52721 Continuous Manufacturing in Secondary Production 529Martin Warman22 Continuous Direct Compression Using Portable Continuous Miniature Modular & Manufacturing (PCM&M) 547Daniel O. Blackwood, Alexandre Bonnassieux, and Giuseppe Cogoni23 Process Control Levels for Continuous Pharmaceutical Tablet Manufacturing 561Niels Nicolaï, Ingmar Nopens, Maxim Verstraeten, and Thomas De BeerPart IV Applied Statistics and Regulatory Environment 58524 Multivariate Analysis for Pharmaceutical and Medical Device Development 587Frederick H. Long25 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization 601Theodora Kourti26 Quality by Design: Pilot to Reality-The Honeymoon Phase to the Stormy Years 631Mary T. am Ende and Christine B. SeymourIndex 645