INSIGHTS ON DOWNSTREAM MANUFACTURING

• Risk Control | Bulk Filling Application

  Learn about a bulk filling system that enables you to achieve risk control, accuracy, and superior product recovery in your fill and finish operations.

• Bulk Filling Of Drug Substance | Accurate Aliquoting

  Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.

• Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing

  Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.

• New Instrumentation Expands Sediment Velocity AUC’s Utility

  Purified adeno-associated viruses (AAVs) are prepared as a variety capsid species that must be characterized and quantified to ensure safety and efficacy.

• Identify And Quantify AAV Fill States Using Analytical Centrifugation

  4/24/2024

  Purified AAVs are prepared as a variety capsid species. To ensure gene therapy safety and efficacy, it is crucial to characterize and quantify those species.

• De-Risking The Aseptic Drug-Filling Process And Optimizing Production

  4/17/2024

  Aseptic drug-filling poses significant risks for manufacturers that can increase costs and timelines. Leveraging proven expertise and efficiency can ensure the production of safe, efficacious products.

• Robust Development Of Downstream Process Technologies For AAV

  4/17/2024

  The focus of this study was to optimize the three primary downstream processing steps for AAV particle purification utilizing a design of experiments (DoE) methodology and screening devices.

• Tips For Viral Vector Production

  4/16/2024

  Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

• What Is A Viral Vector?

  4/16/2024

  Review a novel adenovirus production process that offers scalable, single-use equipment-compatible solutions, reducing production time and cross-contamination risks.