How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging
This feature partnership covers how pharma companies can ensure they are end-to-end compliant with Annex 1 for their primary packaging via a robust CCS.
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Articles
Environmental Monitoring In-Depth Focus 2024
This in-depth focus explores environmental monitoring of compressed gas ports and best practice for minimising contamination risks.
European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
Enzyme replacement therapy: improving outcomes in rare disease
In this article, Dr Alaa Hamed, Global Head of Medical Affairs for Rare Disease at Sanofi, shares why the company’s enzyme replacement therapy Xenpozyme® (olipudase alfa) has promise for the rare genetic disease acid sphingomyelinase deficiency (ASMD).
Advancing NOX inhibitors for treating fibrotic diseases and cancer
This article explores the benefit of NOX inhibitors for fibrotic diseases and cancers and highlights the potential of Calliditas Therapeutics’ drug setanaxib, including its application in wider related indications.
Mpox update – August 2024
This article discusses the impact of the recent mpox emergency following the outbreak of the virus in 2022, highlights the industry’s response, potential vaccine candidates and key recommendations for international management of the disease.
Are we set for the revised EU GMP Annex 1?
23 August 2024 | By
This blog is a summary of the key changes of relevance to primary packaging components
Harnessing the GLP-1R medicine wave
As a promising treatment for type 2 diabetes and obesity, based on key trial data, the market for glucagon-like peptide-1 receptor (GLP-1R) therapies looks set to generate major sales up to 2030.
Targeted therapies for chronic lymphocytic leukaemia in an evolving treatment landscape
Dr Mehrdad Mobasher, Chief Medical Officer for Hematology, BeiGene, discusses the evolution of therapies for chronic lymphocytic leukaemia (CLL), the promise of targeted treatments and what could be on the horizon of the therapeutic landscape for this disease.
Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
Alzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
A holistic approach to safeguard data integrity in Biopharma manufacturing
Data integrity is critical in Biopharma manufacturing yet is often difficult to achieve due to complex regulatory requirements and legacy data management systems, among the many factors. Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. Addressing all these challenges demands…
The route to enhanced gene therapies
In this article, Roger Palframan, Head of US Research at UCB, delves into the potential of gene therapy and which modalities have the most promise, what the industry should prioritise to advance the field, as well as what is needed to develop the workforce.
Improving aseptic connections throughout the manufacturing process
As companies are adapting to EU GMP guidelines for Annex 1 - Manufacture of Sterile Medicinal products, there have been numerous discussions involving the terms sterile and aseptic, as if they were synonymous. Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science® and Executive Director of Microbiology & Sterility Assurance at…
