European Pharmaceutical Review Issue 5 2023
9 November 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
Issue 5 of European Pharmaceutical Review features articles on manufacturing, development and quality control of biopharmaceuticals from antibodies to mRNA and cell and gene therapies.
In this issue, Peter Stenico, Biosimilar Global Platform Head at Sandoz, highlights how emerging technology platforms such as nanobodies, ADCs and cell and gene therapies are “on course to revolutionise medicine,” with significant growth anticipated over the next decade. Stenico looks at the potential expansion of biosimilars in Europe, explaining how creating a sustainable procurement process, that goes beyond price-based tendering, will be key to realising their potential.
When it comes to biologics, scaling up production to ensure global supply is a remarkable process that embodies Industry 4.0 and the very latest in advanced manufacturing technologies. Through process optimisation and investment in such technologies, MSD’s Dublin Biotech site has managed to “triple output annually,” site head Liam Dunne explains.
Additionally, scientists from Roche explore the use of handheld Raman for identification of counterfeit biologics, Lonza discusses the potential of inline Raman spectroscopy for automated bioprocess control, and Samsung Biologics examines scale-up challenges for mRNA-based therapeutics. We also explore opportunities for outsourcing of regulatory activities, the challenges of paediatric drug formulation and much more.
Articles included in Issue 5 of European Pharmaceutical Review:
Quality Risk Management updates
Dave Elder delves into some of the complexities surrounding quality risk management and discusses key revisions to ICH Q9(R1) guidelines.
Continuous direct compression: opening up faster access to oral dose medication
Deborah McElhone, CPI’s Medicines Manufacturing Innovation Centre
IN-DEPTH FOCUS: QA/QC MICROBIOLOGY
Bioburden and sterility testing: how to conserve gene therapy product
Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals
Tom Bujold, Senior Director of Quality Control at REGENXBIO
Developing microbiological QC for ATMPs
Natalie Saunders, Interim Head of QC at Cell and Gene Therapy Catapult
Making ATMPs a reality for rare disease patients
Paolo Morgese, the Alliance for Regenerative Medicine
Detecting counterfeit biologics with handheld Raman
Klara Degardin, Manuel Fellmann, Peter Horváth, and Tobias Mohn from Roche
Manufacturing trends in a modern facility
Liam Dunne, MSD Biotech Site Lead speaks to Danielle Barron
Scaling for effective manufacturing of mRNA-based therapeutics
Eunseo Lee, lead specialist in mRNA manufacturing at Samsung Biologics
Adaptive bioprocessing: utilising inline Raman spectroscopy for automated control
Brandon Downey, Thaddaeus Webster and Carrie Mason, Lonza
IN-DEPTH FOCUS: DRUG FORMULATION
Exploring the complex pathway of paediatric drug development
Tom Hegarty, Head of Technical Operations for Almac Pharma Services
Definitive screening design to accelerate process characterisation
Mourad Mellal, Director of Statistics, Product Development at Catalent