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After decades of development and refinement, the separation of proteins by capillary electrophoresis (CE) has moved beyond the R&D laboratory into the manufacturing quality control laboratory. Here, Giuseppe Peddio and Federica Bisceglia discuss the advancements in CE technology for development applications and batch release for biopharmaceutical products.
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.
Explore how LED microscopy illumination can improve the sustainability of research and development, but also the performance of widefield fluorescence microscopy.
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
Using an investment of more than €2.1 billion, a planned expansion at one of Novo Nordisk’s strategic production sites will include additions such as aseptic production and the extension of its Quality Control Laboratory.
In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.
This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.
Discover how completing your trials in Canada can accelerate your early phase clinical research by six to nine weeks compared to an IND submission.
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
Researchers state the novel high-performance liquid chromatography with diode-array detection (HPLC-DAD) method can be utilised in routine quality control analysis of levofloxacin in pharmaceutical formulation and bioequivalence studies.
In this Q&A Microbiologics’ Brianna DeWitt explores how to make QC with environmental isolates simple and reliable while conquering compliance with regulations and standards.
Camfil´s 10 tips whitepaper will help you choosing the right cartridge dust collection equipment for your tablet press applications.
Effective filtration combined with containment solutions ensure that dust doesn´t escape during normal operation as well as during routine maintenance.
