Newsletter | April 17, 2024

04.17.24 -- A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies

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Effective Strategies For Endotoxin Removal In Biotherapeutic Purification

Endotoxins are common pyrogenic impurities in therapeutic protein preparations that make the next steps in the purification process difficult. Even trace amounts can cause septic shock or tissue damage. In research, endotoxins impair data accuracy and immunological assessments. Their high thermal stability and pH insensitivity add to the challenge of removal. Watch this 15-minute webcast to explore case studies for effective endotoxin removal using various chromatography resins.

FOCUS ON DOWNSTREAM MANUFACTURING

A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies

ATMP manufacturing requires robust contamination control strategies. Let's explore the aseptic risk evaluation model, which complies with evolving global regulatory requirements and best practices.

Optimize And Monitor AAV Capsid Purification Using Mass Photometry

Study the performance of a mass photometer that was used to analyze AAV samples at various stages of purification to confirm column binding, and to monitor elution from the chromatography column.

Enhance Virus Clearance Process Capability With Biodegradable Detergent

Learn more about an effective, biodegradable solution for the viral inactivation process that controls protein impurities and is compatible with downstream unit operations.

Host Cell Protein Analysis: Immunoassays

Learn about host cell proteins (HCPs) and the sensitive and specific orthogonal methods necessary to identify individual HCP impurities that persist through DS purification processes.

The Colloidal Particle Adsorption (CPA) Model In IEX

Learn about an adsorption isotherm class that is based on a colloidal description of proteins and achieves increased accuracy at high column loading in IEX modeling.

Sterilizing Grade Filter Performance With Biologic Drugs

Analyze the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins and explore how filter selection can impact your process.

High Capacity Protein A Resin For Process Intensification In mAb Capture

Find ways to achieve the flexibility you need to maximize the cost-effectiveness of Protein A resins and employ varying strategies during the capture step of downstream purification.

DOWNSTREAM MANUFACTURING SOLUTIONS

Quantify Multiple Targets With The QX600 Droplet Reader - Bio-Rad Laboratories, Inc.

Overcome Lab Challenges With This High-Speed Centrifuge - Danaher Life Sciences

Perform Multiple Chromatography Steps On A Single System - Sartorius

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