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
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Articles
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…
Pharma Horizons: Formulation
European Pharmaceutical Review's latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
Uncovering the potential of ADCs to target tumours
Antibody drug conjugates (ADCs) are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Here, Mary Jane Hinrichs, Senior Vice President of Early Development at Ipsen, examines how ADCs could transform treatment options…
Endotoxin standards: reflection and recommendation
Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
Using rack systems to reduce thermal interactions between vials during freezing
Formulation experts from Polytechnic of Turin, Italy, discuss the impact of freeze-drying on the integrity and stability of pharmaceuticals and how mathematical modelling can improve understanding of the freezing process.
Cleanroom microbiology: single-temperature incubation for EM
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
Botanical drugs – what is the best way forward for regulatory and market approval?
Botanical drugs, also known as traditional herbal therapies, have long been used, but obtaining regulatory approval for these medicines, or therapies, is convoluted. Often manufacturers will market their botanical drugs as dietary supplements or traditional therapies, designations that require far less regulatory approval than marketisation as a drug. In this…
Prodrugs: seeking perfection in an imperfect world
Balancing safety, efficacy and cost in drug development is challenging. Prodrugs offer potential solutions, but also introduce additional complexities, as Dave Elder explains.
