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News
The growing importance of cleaning validation in ADC biologics manufacturing
3+ day, 3+ hour ago (124+ words) Antibody–drug conjugates (ADCs) have emerged as one of the most sophisticated therapeutic modalities in modern biologics manufacturing. By combining the targeting precision of monoclonal antibodies with highly potent cytotoxic payloads, ADCs enable the direct delivery of treatments to diseased…...
eXmoor Pharma and Evox Therapeutics complete technology transfer for Huntington's gene editing programme
4+ day, 20+ hour ago (268+ words) The successful establishment of Evox's proprietary manufacturing process and analytical methods at eXmoor's Bristol facility lays the technical foundation for GMP transfer and future clinical manufacture of the MSH3-targeted therapy CDMO eXmoor Pharma and biotech company Evox Therapeutics have announced…...
Guardtech delivers cleanroom solutions for the aerospace sector’s next frontier
4+ day, 22+ hour ago (177+ words) The aerospace sector has always been driven by ambition. Whether developing advanced aircraft components, satellite systems, zero gravity tech or pioneering components destined for space, manufacturers across the industry share a common goal – to push the boundaries of what is…...
UNC Charlotte and BioCytics target cancer ‘dark genome’ with multi-omics platform
5+ day, 19+ hour ago (313+ words) UNC Charlotte and biotech company BioCytics have launched a two-year research collaboration to investigate the genomic and immune mechanisms that drive cancer progression and treatment response. The pair said in a statement they aim to develop a clinical decision support…...
New chemisorption analyser redefines catalyst characterisation
6+ day, 20+ hour ago (130+ words) Anton Paar introduces the Autosorb 3300: Advanced flow chemisorption analysis with unprecedented ease of use and automation This instrument also introduces a powerful new approach to high-temperature catalyst studies. Its compact furnace achieves temperatures up to 1,200 °C and heating rates of…...
Early phase analytical strategy for biosimilars in a shifting regulatory landscape
1+ week, 1+ hour ago (362+ words) As FDA and EMA guidance continues to reinforce analytical comparability as the foundation of biosimilar development, investing in comprehensive early-stage characterisation is becoming essential to reduce uncertainty and improve development outcomes, says Dr Andrew J. Reason, CEO at BioPharmaSpec Regulatory expectations…...
FPT launches MediSight AI framework to accelerate pharma digital transformation and regulatory compliance
1+ week, 54+ min ago (186+ words) Built on FPT's FleziPT AI ecosystem and guided by its CASAN AI adoption framework, FTP said that the new MediSight framework is structured around three core components. The framework has been designed to support healthcare security requirements, including HIPAA, HITRUST…...
AI in pharma: Practical use cases transforming research, regulatory and medical affairs
1+ week, 2+ hour ago (191+ words) AI and digital transformation expert Sarah Chan explores the rapidly expanding role of artificial intelligence across the pharmaceutical value chain Drawing from her experience leading global AI initiatives at MSD and her work with TOPRA, Sarah presents a practical and…...
Gerresheimer significantly accelerates mould development in medical technology with “Digital Mold”
1+ week, 2+ day ago (730+ words) Manufacturing Chemist Gerresheimer, an innovative system and solution provider and global partner for the pharma, biotech, and cosmetics industries, is setting new standards in medical technology mould and process development with “Digital Mold.” With “Digital Mold,” the company is designing…...
Ansell opens AXIS Portugal to accelerate PPE innovation in Europe
1+ week, 2+ day ago (178+ words) New immersive innovation hub near Coimbra combines safety training, product testing and collaborative R&D to support the future of workplace protection The new centre builds on the success of Ansell's first AXIS site, which launched in Alpharetta, Georgia, in…...