Monoclonal Antibodies
Process Development and Application Expertise

Downstream

From chromatography to filtration and fill finish, the elements of your downstream process are critical to ensure product quality, yield and sterility. We have the products, services and strategies you need to get the most out of every step.


1. Optimizing Re-use and Storage of TFF Cassettes

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  • Industry best practices for TFF cassette reuse and storage
    This webinar investigates the operational requirements and risks of TFF cassette storage and reuse. In addition, it outlines a validation plan for these operations within a manufacturing environment and illustrates how this plan aligns with the latest industry and regulatory guidance.

Qualification of TFF cassette reuse, lifetime, and storage is essential during optimization and qualification of your overall product manufacturing process. Understanding the operational requirements and risks of TFF cassette storage and reuse is essential.

A successful validation plan and analytics is critical to avoid inefficient validation work and data, product recalls, potential plant shutdowns, and even potential patient risk. We offer products, services and insight to help you develop your TFF process and validation plan.


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2. Identifying Optimal Cleaning Procedures for Extended Chromatography Resin Lifetime

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Chromatography media are a major contributor to the cost of monoclonal antibody production. As such, you want to maximize resin lifetime and improve process economics by using an effective cleaning procedure to remove fouling species.

Unfortunately, optimization of resin cleaning procedures through traditional lab-scale experiments can be difficult and require a significant amount of feed material to evaluate a cleaning procedure over multiple cycles.

Miniaturized, high throughput screening tools can help optimize a resin cleaning procedure for extended resin lifetime. Conducting experiments at miniaturized scale significantly reduces the volume of feed material and buffers required for testing, while the high throughput approach reduces experimental time.



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3. Handling High Viscosity Feeds Associated with Increasing Concentration

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Converting infusion-based treatments to subcutaneous injections can increase patient satisfaction. Challenges are:

  • Delivering a much higher drug concentration
  • Properly design the ultrafiltration process and use high-quality formulation buffers
  • Overcoming viscosity limitations with current TFF systems

Pellicon® 3 cassettes, designed for high-viscosity operation, allows drugs to be concentrated to higher levels without modifying your current system or replacing the pump.



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Webinars:

  • Challenges and options in high viscosity tangential flow filtration
    In this webinar you will learn:
    • Options to achieve higher concentration
    • Cleaning recommendations for TFF cassettes used in high viscosity feedstreams
    • Performance comparison between device design in TFF cassettes
  • High-viscosity ultrafiltration formulation
    Formulation by ultrafiltration may be limited in reaching these concentrations due to high pressures caused by high viscosities. The performance of a new PES cassette is described that meets this challenge and allows the use of high caustic concentrations for cleaning and sanitization. Viscosity modifying excipients are also shown to be complementary to the use of the new cassette.

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