Sparsentan
4 December 2023
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Sparsentan (Filspari) is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria
Issue: Vol. 41
Manufacture of Sterile Medicinal Products – meeting EU GMP Annex 1 requirements
4 December 2023
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Now that the EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products are live, the expectations of auditors have changed. Implementing fit-for-purpose Contamination Control Strategies is a challenge for many manufacturers. Anna Cluet of Rephine sets out how to identify compliance gaps and offers suggestions as to how to resolve them.
Assuring quality of oligonucleotide APIs and DPs
1 December 2023
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The development of oligonucleotide therapeutics continues to accelerate with progress in oligonucleotide chemistry and adoption of delivery technologies. This article will discuss the necessary steps to execute to assure quality of your oligonucleotide APIs and DPs, and compliance with agency expectations.
YMC – Improved Oligo and Peptide Purification using next generation LC-phases
1 December 2023
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Molecules of the future with high demands on purity Therapeutic oligonucleotides and peptides
Peptide-based nanoparticles for extrahepatic delivery of therapeutic RNA
1 December 2023
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RNA therapeutics has evolved tremendously during the las two decades. Eighteen RNA medicines are now on the market, but major challenges still remain. These challenges include finding strategies to enable the use of RNA therapeutics outside the liver in a safe and efficacious manner. This overview summarises the advances that industrial peptide-based nanoparticles are making on their way to the clinic. Peptide-based platforms offer significant advantages to deliver RNA medicines extrahepatically, including liver avoidance, decreased immunotoxicity and enhanced endosomal release.
The importance of investments to tackle the future challenges
1 December 2023
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This year’s edition of CPhI has once again proven the excitement and vitality of the pharmaceutical industry. Among the most significant highlights, the recognition of Enrico Zodio as CEO of the year during the prestigious CPhI Pharma Awards has shed light on an exceptional leader. Furthermore, the spotlight on companies like PROCOS, committed to a constant pursuit of quality, technology, and human resources…
Solving the last (or first!) mile of global RIM transformation: improving local Affiliate engagement
6 October 2023
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Building on his recent talk at Amplexor (ArisGlobal)’s annual global BE THE EXPERT conference, Steve Gens of Gens & Associates reports the top-level findings of a far-reaching new regulatory study into the evolving role and challenges at a regional and country level. Improving local Affiliate effectiveness is critical for a true end-to-end global regulatory information management capability.
The biocidal product regulation10 years on
6 October 2023
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Biocides are important tools for society to maintain its standards of health and to achieve its targets for a sustainable future. The benefits that biocides offer to meet these goals are balanced by the need to ensure they can be used safely. The Biocidal Product Regulation (BPR) controls the use of biocides and it has been in force now for 10 years. The BPR is arguably the most complex piece of legislation regulating the use of chemicals in Europe. Its complexity is compounded by delays in delivering its core purpose. This article looks at some of the changes to the BPR over the last 10 years, it considers progress made in delivering key regulatory objectives and offers some thoughts on how the BPR might evolve in the future.
Carin Seechurn, Associate Director – Technology Solutions – Sinocompound
6 October 2023
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How does Sinocompound ensure that customers can access the best-performing catalysts and ligands,
Carla MOESSINGER, Business Development Manager for IV Solutions & Contract Manufacturing, Marga Viñes, Senior Business Development Manager for Contract Manufacturing at Grifols
5 October 2023
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How does Grifols Partnership ensure successful project completion when working with small and emerging