Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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Articles
Understanding the evidence used in drug product withdrawals
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.
Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
NK cell immunotherapy: what’s next in clinical development?
In this interview, Innate Pharma’s Yannis Morel, Executive Vice President of product portfolio strategy and business development, delves into the unique advantages of using multi-specific antibodies capable of engaging NK cells against tumours for oncology indications, and shares key data from the company’s ongoing and recent clinical trials.
Advancing AOCs to transform the delivery of RNA therapeutics
In this article, Dr Michael Flanagan discusses how a new class of medicines called antibody oligonucleotide conjugates (AOCs) have the potential to overcome a major challenge encountered with many established RNA-based therapeutics: delivery to tissues outside the liver. Last year, AOCs demonstrated the first-ever successful targeted delivery of RNA into…
Embracing automation in sterile manufacturing
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
Elevating pharmaceutical manufacturing processes with real-time insights
(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at how this transformative approach…
Challenging applications of capillary electrophoresis in biopharmaceutical analysis
After decades of development and refinement, the separation of proteins by capillary electrophoresis (CE) has moved beyond the R&D laboratory into the manufacturing quality control laboratory. Here, Giuseppe Peddio and Federica Bisceglia discuss the advancements in CE technology for development applications and batch release for biopharmaceutical products.
Drug development trends: insight from Thermo Fisher’s Anil Kane
In this interview, Anil Kane, Executive Director and Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific discusses innovations in oral delivery of biologics, the rising popularity of prefilled syringes as well as global pharma trends in regulation and manufacturing.
Cell and gene therapy: manufacturing and talent trends 2023
In this interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.
Digitalisation and PAT: current landscape and future trends
In this exclusive interview from CPHI 2023, Mohamed Noor, Digitalization Manager at the National Institute for Bioprocessing Research and Training (NIBRT), explores the trends, challenges and opportunities that digitalisation and process analytical technology (PAT) have within the biopharmaceutical industry.
Advancing clinical development in haematology oncology
Newly appointed Vice President of Medical Affairs, Europe at BeiGene, Dr Jan-Henrik Terwey, provides exclusive insight on clinical development in the haematology/oncology space, and highlights significant data for its BCL-2 inhibitor, sonrotoclax.
Guide to Outsourcing 2023
In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.
Formulation In-Depth Focus 2023
This in-depth focus features articles on paediatric formulations as well as the role of definitive screening design in improving biopharmaceutical development.
QA/QC & Microbiology In-Depth Focus 2023
This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.
