We demonstrate how a mAb purification batch process can be converted into a stepwise intensified batch process, successfully eliminating intermediate steps and achieving over 13% cost reductions.
This study explores the feasibility of using single-use chromatography membrane technology as an alternative to resin-based chromatography in an ADC process.
Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.
Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
To meet large-scale production challenges, a modular platform-based approach was developed to offer a simplified, standardized design for protein- and virus-based therapy production processes.
Review the capabilities and robustness of a new single-use fermenter in a fast, exponentially growing, high cell density Escherichia coli (E. coli) process.
Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.
Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.