Leveraging Novel Analytical Approaches For Advanced Therapies
The characterization and analysis of advanced therapies, such as cell and gene therapies (CGTs) can be difficult, as these products are designed to function using complex mechanisms of action (MOA)s. There are a wide range of challenges associated with accurately assessing the potency and impurity profiles of these complex biologicals. As many CGT programs qualify for accelerated review pathways, novel approaches for analysis and characterization can help generate data that allows for real-time decision making and faster development timelines. Catalent has developed a relative potency bioassay using quantitative polymerase chain reaction (qPCR) to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay platform can be used to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency for CGTs, mRNA- and other nucleic acid-based therapies.
Oligonucleotide Analysis in Pharmaceutical Quality Control
January 14th 2025Melting point determination using ultraviolet-visible (UV-Vis) spectrophotometry can be used as a sequence-specific method for identifying therapeutic oligonucleotides in pharmaceutical quality control. This method offers a simple, highly selective approach to differentiate between isomers and ensure the integrity of oligonucleotide active pharmaceutical ingredients (APIs) and drug products.
Keeping Up With Emerging Analytical Technology
January 9th 2025There are several advantages to using a novel capillary electrophoresis-mass spectrometry (CE-MS) device. The REBEL from 908 Devices offers a streamlined and efficient alternative to traditional liquid chromatography-mass spectrometry (LC-MS) for bioprocess monitoring. This paper highlights how this new technology can simplify media analysis, reduce method development time, and improve real-time data collection for biotherapeutic production.
Cell Density Applications eBook (Jan 2025)
January 8th 2025The eBook features must-see examples of real applications using Hamilton viable cell density monitoring (Incyte) and total cell density monitoring (Dencytee) and demonstrates how to leverage Viable Cell Density Monitoring in your processes.
White Paper: The PAT Pathway to Scalable and Sustainable Precision Fermentation
January 8th 2025Precision fermentation, a sustainable method for producing alternative food ingredients, faces significant technical challenges. This white paper explores the critical role of Process Analytical Technology (PAT) in overcoming these hurdles and ensuring product quality through a Quality-by-Design (QbD) approach. Through a comprehensive review of literature and case studies, key technical challenges are identified to demonstrate how PAT can enhance scalability and sustainability. This paper also highlights the transformative potential of PAT in advancing precision fermentation as a reliable solution for addressing nutritional deficiencies and fostering a circular economy.
