FEATURED APPLICATION CONTENT

• 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.

• Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks

  Discover a modeling approach employing artificial neural networks (ANNs) using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated (180 mg/ mL) mAbs.

• Sterile Filtration And Quality Risk Management

  During the manufacture of sterile products, process control is essential. Here, we explore the role of filtration for bioburden control in quality risk management and contamination control strategies, EU GMP Annex 1, and more.

• 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.

• COGs Process Economics For Autologous Cell Therapy

  Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.

• Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges

  Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain in the development of RNA-based vaccines and therapeutics. Learn how NxGen™ mixing can solve three key challenges.

• Alkaline Stability Of Modern Protein A Chromatography Resins

  Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.

• Protein L Affinity Resin Is Ready To Move To Manufacturing

  Discover a protein L affinity chromatography resin that is well suited for use in biomanufacturing and offers increased binding capacities compared to other resins.

• AAV Full/Empty Capsid Separation Using Mechanistic Modeling

  In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl₂ is used as an elution additive.

• Recombinant Protein Purification Optimization With HIC

  A step-by-step high-throughput process development (HTPD) workflow to determine the optimal resin and initial conditions for hydrophobic interaction chromatography (HIC).

• Alkaline Stability Of Fc And VH3 Binding In Protein A Resins

  In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).

• Controlling Trace Impurities In Chemically Defined Media

  Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.