FEATURED APPLICATION CONTENT

• The Value Of Spent Media Analytics For Optimizing Cell Culture Performance

  Explore how valuable insights into the status of cells in culture from the analysis of spent media can support more productive processing as well as medium formulation or culture parameter optimization.

• Chromatographic Separation Of Full And Empty AAV8 Capsids

  Here, we demonstrate a rapid method for the separation of empty and full AAV8 particles by linear gradient elution on CIMmultus® QA monoliths with 80% recovery.

• Intensifying A mAb Polishing Platform

  We demonstrate how a mAb purification batch process can be converted into a stepwise intensified batch process, successfully eliminating intermediate steps and achieving more than 13% cost reductions.

• Optimizing And Intensifying ADC Aggregate Removal With A DoE Approach

  This study explores the feasibility of using single-use chromatography membrane technology as an alternative to resin-based chromatography in an ADC process.

• Increasing Bioavailability With Amorphous Solid Dosage Formulations

  Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor (TKI) drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.

• Extractables And Leachables: Risk Management And Analytical Solutions

  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.

• Simplifying Large-Scale Single-Use Filtration With A Novel Modular Approach

  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.

• Take Advantage Of Single-Use Technologies For Microbial 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.

• Developing A HIC Polishing Step For The Removal Of mAb Aggregates

  Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

• Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks

  Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

• Sterile Filtration And Quality Risk Management

  Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

• Recommendations For Successful IND Approval Of RNA-LNP Drugs

  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.