APR March 2024 - 7

« Editorial Advisory Board
Shaukat Ali, Ph.D.
Sr. Director, Scientific Affairs & Technical Marketing
Ascendia Pharma, Inc.
Ghulam Shabir Arain, Ph.D., CSci, CChem,
FRSC, FCQI
Managing Director
DGS Pharma Consulting Ltd., UK
Katherine Bakeev, Ph.D.
Director of Analytical Services and Support
B&W Tek, Inc.
Douglas J. Ball, MS
Diplomate, American Board of Toxicology; Research Fellow, Drug
Safety Research & Development
Pfizer Global Research & Development
Suraj Baloda, Ph.D.
Founder and President
SARMICON, LLC.
Rory Budihandojo
Director, Quality Systems Audit
Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd.
Harsh Chauhan, Ph.D.
Assistant Professor
School of Pharmacy & Health Professions
Creighton University
Robert V. Chimenti
Sr. Strategic Applications Engineer
Innovative Photonic Solutions
Adjunct Professor
Rowan University
Emil W. Ciurczak, Ph.D.
Doramaxx Consulting
Rick E. Cooley
Retired
Eli Lilly & Co., Inc.
Weiguo Dai, Ph.D.
Scientific Director, Janssen Fellow, Drug Product Development
Johnson and Johnson
Nila Das, Ph.D.
Senior Research Investigator
Bristol-Myers Squibb
Vivek Dave, Ph.D.
Assistant Professor, Pharmaceutical Sciences
St. John Fisher College, Wegmans School of Pharmacy
Michael Dong, Ph.D.
Consultant
MWD Consulting
Dr. Thomas Dürig
Sr. R&D Director, Pharmaceutical and Food Ingredients
Ashland Inc.
Walter Dziki, Ph.D.
Associate Research Fellow
Abbott Laboratories
Stuart Farquharson, Ph.D.
President & CEO
Real-Time Analyzers, Inc.
John Finkbohner, Ph.D.
Director, Regulatory Affairs
MedImmune
Adam S. Goldstein
Senior Manager, Clinical Purification, Operations/Development
Genentech
Davy Guillarme, Ph.D.
Senior Lecturer, School of Pharmaceutical Sciences
University of Geneva, University of Lausanne
Brian Lingfeng He
Research Investigator
Bristol-Myers Squibb
Ronald Iacocca, Ph.D.
Senior Research Advisor, Product and Process Performance
Eli Lilly & Co.
Maik W. Jornitz
Vice President of Business Development
G-Con Manufacturing, LLC
Hemant N. Joshi, Ph.D., MBA
Principal
Tara Innovations LLC
Ian Lewis, Ph.D.
Head of Technical Marketing
Endress+Hauser Optical Analysis
Ralph Lipp, Ph.D.
President and CEO
Lipp Life Sciences LLC
Jack Lysfjord
Principal Consultant
Lysfjord Consulting LLC
Steven R. Maple, Ph.D.
Head of Pharmaceutical Technology Development Dept.
Lilly Research Laboratories, Eli Lilly & Co., Inc.
Jerold M. Martin
Senior Vice President, Scientific Affairs
Pall Life Sciences
John P. Mayer
Senior Research Scientist
Indiana University
Michael J. Miller, Ph.D.
President
Microbiology Consultants, LLC
Ronald W. Miller, Ph.D., MBA
President , Technology Consultant
Miller Pharmaceutical
Ganapathy Mohan, Ph.D.
Head of Global CMC Regulatory Affairs
Merck, Sharp and Dohme Corp.
Shane R. Needham, Ph.D.
Laboratory Director
Alturas Analytics, Inc.
Daniel L. Norwood, MSPH, Ph.D.
Distinguished Research Fellow
Boehringer Ingelheim Pharmaceuticals, Inc.
David Radspinner
Director of Marketing and Applications Support for BioProcess
Production
Thermo Fisher Scientific
Aniruddha M. Railkar, Ph.D.
Lead Regulatory Affairs CMC
Ascentage Pharma
Gary E. Ritchie
President
Council For Near Infrared Spectroscopy
Rodolfo J. Romañach, Ph.D.
Professor of Chemistry
University of Puerto Rico, Mayagüez Campus
Shouvik Roy, Ph.D.
Principal Scientist, Organizational Unit Leader in
Drug Product Engineering
Amgen
Jim Rydzak
Investigator, Strategic Technology Division
GlaxoSmithKline
Ronak Savla
Fellow
Catalent Applied Drug Delivery Institute
Ken Seufert
CEO
JRS Pharma LP
Donald C. Singer
Senior Microbiology Technical Consultant
GTC, ECOLAB LIFE SCIENCES
Onkar N. Singh, Ph.D., MBA
Director, Pharmaceutical Development at CONRAD
Eastern Virginia Medical School
Allen Templeton, Ph.D.
Associate Vice President
Formulation Sciences Merck Research Laboratories
Zhenyu Wang, Ph.D.
Associate Principle Scientist and Group Leader
Respiratory Product Development
Merck & Co.
Wayne K. Way, Ph.D.
Analytical Business Marketing Manager
MilliporeSigma
Larry Wigman, Ph.D.
Principal Scientific Manager
Genentech
www.americanpharmaceuticalreview.com |
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APR March 2024

Table of Contents for the Digital Edition of APR March 2024

Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
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