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In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
12 March 2024 | By Actylis
Join us as we look at how the outsourcing of buffers is helping biopharma drug manufacturers to streamline their processes.
8 March 2024 | By Thermo Fisher Scientific
Discover the valuable role ultraviolet-visible spectroscopy can play in quickly and accurately monitoring a drug as it moves through the research & development workflow and enabling quality and regulatory compliance through the manufacturing process.
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.
Designing systems for delivery of biologics is often a significant challenge during clinical development. Here, Dave Li, Edyta Działo and Anna Baran of KCR Consulting highlight the need for balancing safety, effectiveness, cost and reducing patient discomfort.
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
During his tenure as AbbVie’s CEO, Richard Gonzalez successfully navigated the end of exclusivity for the biologic Humira in the US.
A new World Health Organization (WHO)-driven initiative aims to enhance bioproduction capabilities for biological products in low- and middle-income countries (LMICs).
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
15 February 2024 | By European Pharmaceutical Review, sponsored by Mettler Toledo, Bruker and 908Devices
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
The fluid management for mRNA, LNPs, pDNA and viral vectors for cryopreservation are often prone to inefficiencies. SUT optimizes the manufacturing process.
Liam Dunne, MSD Biotech Site Lead, speaks to Danielle Barron about how the Dublin site is leveraging the latest technologies, from real-time process monitoring to the latest upstream techniques, helping to ensure reliability and quality of global supply.
