European Pharmaceutical Review Issue 3 2024

Articles included in Issue 3 of European Pharmaceutical Review include:

FOREWORD
Seeking perfection in an imperfect world
Dave Elder
David P Elder Consultancy

REGULATORY INSIGHT
Botanical drugs – what is the best way forward for regulatory and market approval?
Taly Dvorkis
Fieldfisher

QA/QC MICROBIOLOGY IN DEPTH FOCUS
Implementing single temperature incubation
Guillaume Pinon
Laboratoires SERVIER Industrie

Endotoxin standards: reflection and recommendation
Dr Radhakrishna Tirumalai
Merck Research Laboratories (MRL)
Karen Zink McCullough
MMI Associates, LLC

Improving aseptic connections throughout the manufacturing process
Vanessa Vasadi Figueroa
VVF Science^® and Executive Director of Microbiology & Sterility Assurance at Quality Executive Partners, Inc

GUIDE TO DATA INTEGRITY
Harnessing microbial identification data to boost confident decision-making
Mirna Vazquez
Charles River Laboratories

Data integrity and AI: how pharma can build a data-driven future
Dr Klaus Heumann
LabVantage - Biomax GmbH
Sayan Basu
LabVantage Solutions

A holistic approach to safeguard data integrity in Biopharma manufacturing
Dr Fausto Artico
Transformational Execution
argenx

DOWNSTREAM BIOPROCESSING IN DEPTH FOCUS
Considerations for successful tech transfer of a biologic purification process
Andrew Brown, Samit Patel and Mark Whickman
Lonza

Surfactant replacement options for Triton X-100 in bioprocessing
Allan Matte
National Research Council Canada

DRUG DEVELOPMENT IN DEPTH FOCUS
The promise and hurdles of restoring immune tolerance
Dr Christian Schröter
Topas Therapeutics

MANUFACTURING
Optimising the biomanufacturing enterprise
Jeffrey N Odum
International Society for Pharmaceutical Engineering (ISPE)

VACCINE DEVELOPMENT
Vaccine development – progress in infectious diseases and beyond
Dr Jamila Louahed
GSK Vaccines

CONTINUOUS MANUFACTURING
Continuous manufacturing: an evolving technology for drug substance manufacturing
Matthew M. Bio
Cambrex

DRUG DEVELOPMENT
Understanding cardiopulmonary risk in COPD and opportunities for new treatment modalities
Yang Xu
AstraZeneca UK
Dr Pete Wilson
The Middlewood Partnership

BIOFERMANTATION
Combining biofermentation and chemical synthesis to manufacture complex molecules in pharmaceutical applications
David Blanco
SuanFarma Group

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