APR Nov/Dec 2022 - 4

IN THIS ISSUE
10 INSIDER INSIGHT
The Fractured Landscape for Pharmaceutical Manufacturing Education:
How a fractured training and upskilling landscape feeds
continuing pharma quality and compliance issues
Michael I. Levitt, Vice President, Strategic Operations
Quality Executive Partners
14 MANUFACTURING
Right First Time: Unlocking the Competitive Benefits of Better
Batch Release
Aladdin Mandishah, Global Life Sciences Industry Solutions Manager
SAP
28 FORMULATION AND DEVELOPMENT
A CDMO Perspective on Developing Biological Modalities from
Discovery to Commercialization
Jim Huang, PhD and Shaukat Ali, PhD
Ascendia Pharma
46 BIOPHARMACEUTICALS
VENDOR VIEWPOINT
Potential of Gene and Cell Therapies for Patients with Rare/Orphan
Diseases, Ensuring Access to Treatment
Andy Szczotka, PharmD, Chief Pharmacy Officer
AscellaHealth
52 MANUFACTURING
FDA's Updated Inspectional Approach in the Post-Pandemic Landscape
Arif S. Noorani, Partner and Priyanka Amirneni, Associate
Food, Drug and Medical Device Compliance and Enforcement, Sidley Austin LLP
60 DRUG DELIVERY
Stretching the Limits of Dry Powder Pulmonary Drug Delivery
Pauline van der Wijst - Janssen
Product Application Specialist in DFE Pharma's Inhalation division
Ross Blezard
Product Application Specialist in DFE Pharma's Biopharma division
66 SPECTROSCOPY
Detecting Trace Elements in Single Cells with ICP-MS
Simon Nelms, ICP-MS Product Marketing Manager
Thermo Fisher Scientific
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| November/December 2022
64 Endotoxin Testing Considerations - Reducing LAL Use with
Compendial Methods
Hayden Skalski, Life Sciences Product Application Specialist
Sievers Instruments
REGULAR FEATURES
6 Message from the Editor
7
8 CN Perspectives
9
FACILITY TOUR
56 ATMP and Cell and Gene Therapy Testing Services
for the Global Market
Eurofins BioPharma Product Testing
QC CORNER
36 Coping with Matrix Effects Caused by Phospholipids in
Biological Samples
Sponsored Content from MilliporeSigma
»
71 FORMULATION AND DEVELOPMENT
What's Keeping Your Enterprise from Fully Leveraging Its Data?
Jim Olson, CEO
Flywheel
74 ROUNDTABLE
Biopharmaceuticals and Biosimilars
Editorial Advisory Board
Social Media Connections
82 P.I.N. Points
84 Advertiser's Index
SPECIAL FEATURES
77
Drug Development & CDMO Survey
Sponsored by Ascendia
78 Equipment Focus
80 Editor's Top Tech
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
