APR Sept/Oct 2023 - 4

IN THIS ISSUE
31 INSIDER INSIGHT
From Guidelines to Standards: Why Comprehensive AI Regulation is
Essential to Spurring Innovation
Gordon Kessler, JD, MBA, General Counsel
Chief Administrative Officer at AiCure
56 FORMULATION AND DEVELOPMENT
R Code to Estimate Probability of Passing USP Dissolution Test
Prasanth Sambaraju
Independent Researcher
62 FORMULATION AND DEVELOPMENT
Cloud Computing for Drug Discovery: The Time is Now
Ashutosh Jogalekar, PhD, Head of Product, OpenEye
Cadence Molecular Sciences
70 MANUFACTURING
Simplifying Finished Product Manufacturer Site Transfer Variations
Valeria Grigoriev, Senior Regulatory Affairs Specialist
Arriello
74 FORMULATION AND DEVELOPMENT
Advancing Regulatory Compliance with Natural Language Processing
Jane Reed, Director Life Science Safety Regulatory Quality
IQVIA
78 DRUG DELIVERY
Finding a Greater Vantage Point for Creating Green Therapies
Nicholas Smalley, Vice President of Global Regulatory Affairs
Gareth Knowling, Global Sourcing and Procurement Manager
Kindeva Drug Delivery
REGULAR FEATURES
6 Message from the Editor
7
8 CN Perspectives
9
»
89 ROUNDTABLE
Drug Delivery
92 MANUFACTURING
Accelerating Biologics R&D with Unified Software and Data Flows
Christian Olsen, Associate VP, Industry Principal, Biologics
Dotmatics
96 FORMULATION AND DEVELOPMENT
The Role of Data in the Pharmaceutical Lifecycle
Andrew A. Anderson, Vice President Innovation & Informatics Strategy
ACD/Labs
99 BIOPHARMACEUTICAL
Uniting Quality Expectations on Reinvigorated Biopharma Campuses
Rey Hernandez, Senior Director of Quality Assurance & Control, Life Sciences
JLL
107 BIOPHARMACEUTICAL
Maximizing the Commercialization Potential of Cell and Gene Therapies
Moderator: Dr. Christian K. Schneider, Head
Biopharma Excellence
Panelists: Keith Thompson, Chairma, NK:IO
Michael May, President & CEO
The Centre for Commercialization of Regenerative Medicine (CCRM)
Sven Kili, CEO, Antion Biosciences
110 MICROBIOLOGY
Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
Richard Chai, Senior Technical Service Manager
STERIS Corporation
David J.W. Barber, Consultant
Editorial Advisory Board
Social Media Connections
49 Editor's Top Tech
116 Equipment Focus
118 P.I.N. Points
120 Advertiser's Index
SPECIAL FEATURES
86 Facility Tour - Eurofins BioPharma Product Testing
94
An Interview with Jason Downing,
Senior Product Manager, TriLink BioTechnologies®
QC CORNER
50 The Intricacies of Testing for Mycoplasmas
in Cell Culture Systems
Sponsored Content from MilliporeSigma
4 |
| September/October 2023
VENDOR VIEWPOINT
114 Continuous & Intervention-Free Microbial Monitoring
TSI®
CGT CIRCUIT
68 Navigating the Complex Testing Strategies for
Viral Vector-based Gene Therapies
Sponsored Content from SGS North America, Inc.
WHITEPAPERS AND CASE STUDY
82 Microbial Testing for the Pharmaceutical Industry
Thermo Fisher Scientific
102 VITAMIN C - Tableting with LUBRITAB® RBW Lubricant
JRS PHARMA LP
104 Leveraging Analytical Technology Process for CMC
Regulatory Compliance Associates®
APR Sept/Oct 2023

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