J.T.Baker® Cell Lysis Solution and J.T.Baker® Endonuclease

J.T.Baker® Cell Lysis Solution and J.T.Baker® Endonuclease
Product Description

J.T.Baker® Cell Lysis Solution and J.T.Baker® Endonuclease - two innovative products that together sustainably optimize the gene therapy harvest process. Readily biodegradable and REACH compliant J.T.Baker® products offer a scalable and sustainable clarification process. Better together, these highly effective and ready-to-use reagents minimize process challenges, so you can scale up your process without compromising performance excellence.

Avantor

  • US
  • 2022
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
Manufacturer/Innovator
Primary activities
Chemical Development
Custom Manufacturing/Custom Synthesis
Excipients Manufacturer
Supply Chain

Avantor

  • US
  • 2022
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
Manufacturer/Innovator
Primary activities
Chemical Development
Custom Manufacturing/Custom Synthesis
Excipients Manufacturer
Supply Chain

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Avantor resources (17)

  • Video Viral Clearance Breakthrough: Enhancing Efficacy and Protein Stability With a Regulatory Compliant, Novel Detergent

    Effective viral clearance processes during biologics manufacturing are the final shield to ensure product and patient safety. One of the classical methods for viral inactivation (VI) is the detergent treatment step in manufacturing of various drug modalities, including antibodies, plasma-derived products and AAV. In this presentation, we will discuss the application of an environmentally safe and sustainable alternative for Triton X-100 to enhance VI while maintaining compliance with regulations. An extensive study with different model viruses demonstrated its capability of providing >6.5 Log of viral inactivation and high virus killing kinetics independent of operational temperatures (4 ⁰C to RT) will be shown. Health-based exposure information will be presented for use in determining operator and patient safety. Other benefits of using this detergent include no impact on product stability over typical operating durations and sensitive molecules such as bi-specifics or on process performance. This detergent can easily be removed from the process by typical chromatography techniques and be detected by a simple analytical assay.
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    Biopharmaceutical development and production requires the investment of significant time and resources. Manufacturing procedures must be efficient, robust and productive to minimize failure risk and ensure targets are met. With increasing product titers, greater volumes of process buffer are required to meet processing demand. Increased buffer volumes place additional pressure on buffer hold and storage area constraints, particularly for companies that prefer to prepare their buffers in advance. Complex scheduling of staff and equipment is necessary to ensure there is an adequate quantity of QC-released process buffers prepared and ready for an entire batch. These logistical challenges increase in plants producing multiple products due to the need for different buffer solutions for different process applications. Furthermore, continuous manufacturing requires different considerations, as it requires constant supply of process buffers. Identifying the right buffer preparation strategy for a given facility and operation is key. While holding larger buffer quantities might be suitable for a fed-batch processes, in-line dilution or conditioning deserves careful evaluation for continuous manufacturing. Operational modifications in buffer management allow manufacturers to maximize their output without significantly altering their production approach. This can enhance several measures of efficiency, including faster drug product release, increased productivity of GMP manufacturing, reduced footprint, enhanced flexibility and improved quality. In this presentation, we will take a holistic approach to buffer management, discuss the known and unknown challenges, and consider different options of buffer preparation, weighing the merits of in-house vs. outsourcing. Conceptual design scenarios in both existing and new facilities will be shared to assist with the economics and logistics of the buffer journey. And finally, we will show how the best buffer management approaches come together to deliver significant operational benefits —allowing biologics manufacturers, including CDMOs, to remain nimble and competitive.
  • Video Scaling Cell Therapy Manufacturing

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