Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
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Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
Here, Dr Jinpeng Li at WuXi AppTec reveals the analytical challenges that are hindering advancement of oligonucleotide therapeutics, medicines which have demonstrated clinical promise in the gene therapy space, and discusses promising analytical innovations.
3 February 2025 | By ACD Labs
Learn about available formats for analytical data standardization, limitations, and how to ensure data is usable by lab scientists and AI/ML.
The spectroscopy-based study highlights the importance of integrating data-driven approaches to enhance isomer discrimination.
29 January 2025 | By European Pharmaceutical Review, sponsored by 908Devices and Bruker BioSpin
During this virtual panel, industry experts will explore the latest developments and biggest challenges in process analytical technology (PAT) today.
24 January 2025 | By LabVantage Solutions
Find out how to take advantage of a connected digital ecosystem to enhance quality control, streamline manufacturing and, ensure regulatory compliance
Integration of industry 4.0 is anticipated to steer growth of the process spectroscopy market into the next decade, a report predicts.
The HPLC technique provides “significant improvements” over traditional methods for carvedilol determination and has broad applications for pharmaceutical quality control, research suggests.
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
Increased adoption of artificial intelligence (AI) and machine learning (ML) in microbiology is set to be a key driver of the global automated microbiology market to 2033, research asserts.
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
Find out what is on offer for pharma professionals working in analytical development and microbiology QC at the 12th PharmaLab Congress being held in Germany in 2024.
The detection method was designed for continuous culture monitoring of cell therapy products and required minimal sample preparation, research showed.