APR Sept/Oct 2023 - 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
Chris Halling
Senior Manager, Global Communications
and European Marketing
Catalent Pharma Solutions
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.
Director of Marketing
Kaiser Optical Systems, Inc.
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 |
| 7
»
http://www.americanpharmaceuticalreview.com

APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023

INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
Facility Tour - Eurofins BioPharma Product Testing
ROUNDTABLE - Drug Delivery
MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
WHITEPAPER - Leveraging Analytical Technology Process for CMC
BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - Cover1
APR Sept/Oct 2023 - Cover2
APR Sept/Oct 2023 - 1
APR Sept/Oct 2023 - 2
APR Sept/Oct 2023 - 3
APR Sept/Oct 2023 - 4
APR Sept/Oct 2023 - 5
APR Sept/Oct 2023 - 6
APR Sept/Oct 2023 - 7
APR Sept/Oct 2023 - 8
APR Sept/Oct 2023 - 9
APR Sept/Oct 2023 - 10
APR Sept/Oct 2023 - 11
APR Sept/Oct 2023 - 12
APR Sept/Oct 2023 - 13
APR Sept/Oct 2023 - 14
APR Sept/Oct 2023 - 15
APR Sept/Oct 2023 - 16
APR Sept/Oct 2023 - 17
APR Sept/Oct 2023 - 18
APR Sept/Oct 2023 - 19
APR Sept/Oct 2023 - 20
APR Sept/Oct 2023 - 21
APR Sept/Oct 2023 - 22
APR Sept/Oct 2023 - 23
APR Sept/Oct 2023 - 24
APR Sept/Oct 2023 - 25
APR Sept/Oct 2023 - 26
APR Sept/Oct 2023 - 27
APR Sept/Oct 2023 - 28
APR Sept/Oct 2023 - 29
APR Sept/Oct 2023 - 30
APR Sept/Oct 2023 - INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
APR Sept/Oct 2023 - 32
APR Sept/Oct 2023 - 33
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
APR Sept/Oct 2023 - 35
APR Sept/Oct 2023 - 36
APR Sept/Oct 2023 - 37
APR Sept/Oct 2023 - 38
APR Sept/Oct 2023 - 39
APR Sept/Oct 2023 - 40
APR Sept/Oct 2023 - 41
APR Sept/Oct 2023 - 42
APR Sept/Oct 2023 - 43
APR Sept/Oct 2023 - FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
APR Sept/Oct 2023 - 45
APR Sept/Oct 2023 - 46
APR Sept/Oct 2023 - 47
APR Sept/Oct 2023 - 48
APR Sept/Oct 2023 - 49
APR Sept/Oct 2023 - QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
APR Sept/Oct 2023 - 51
APR Sept/Oct 2023 - MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
APR Sept/Oct 2023 - 53
APR Sept/Oct 2023 - 54
APR Sept/Oct 2023 - 55
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
APR Sept/Oct 2023 - 57
APR Sept/Oct 2023 - 58
APR Sept/Oct 2023 - 59
APR Sept/Oct 2023 - 60
APR Sept/Oct 2023 - 61
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
APR Sept/Oct 2023 - 63
APR Sept/Oct 2023 - 64
APR Sept/Oct 2023 - 65
APR Sept/Oct 2023 - 66
APR Sept/Oct 2023 - 67
APR Sept/Oct 2023 - CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
APR Sept/Oct 2023 - 69
APR Sept/Oct 2023 - MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
APR Sept/Oct 2023 - 71
APR Sept/Oct 2023 - 72
APR Sept/Oct 2023 - 73
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
APR Sept/Oct 2023 - 75
APR Sept/Oct 2023 - 76
APR Sept/Oct 2023 - 77
APR Sept/Oct 2023 - DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
APR Sept/Oct 2023 - 79
APR Sept/Oct 2023 - 80
APR Sept/Oct 2023 - 81
APR Sept/Oct 2023 - WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
APR Sept/Oct 2023 - 83
APR Sept/Oct 2023 - 84
APR Sept/Oct 2023 - 85
APR Sept/Oct 2023 - Facility Tour - Eurofins BioPharma Product Testing
APR Sept/Oct 2023 - 87
APR Sept/Oct 2023 - 88
APR Sept/Oct 2023 - ROUNDTABLE - Drug Delivery
APR Sept/Oct 2023 - 90
APR Sept/Oct 2023 - 91
APR Sept/Oct 2023 - MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
APR Sept/Oct 2023 - 93
APR Sept/Oct 2023 - An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
APR Sept/Oct 2023 - 95
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
APR Sept/Oct 2023 - 97
APR Sept/Oct 2023 - 98
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
APR Sept/Oct 2023 - 100
APR Sept/Oct 2023 - 101
APR Sept/Oct 2023 - WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
APR Sept/Oct 2023 - 103
APR Sept/Oct 2023 - WHITEPAPER - Leveraging Analytical Technology Process for CMC
APR Sept/Oct 2023 - 105
APR Sept/Oct 2023 - 106
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
APR Sept/Oct 2023 - 108
APR Sept/Oct 2023 - 109
APR Sept/Oct 2023 - MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
APR Sept/Oct 2023 - 111
APR Sept/Oct 2023 - 112
APR Sept/Oct 2023 - 113
APR Sept/Oct 2023 - VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - 115
APR Sept/Oct 2023 - 116
APR Sept/Oct 2023 - 117
APR Sept/Oct 2023 - 118
APR Sept/Oct 2023 - 119
APR Sept/Oct 2023 - 120
APR Sept/Oct 2023 - Cover3
APR Sept/Oct 2023 - Cover4
https://www.nxtbookmedia.com