Milliporesigma Brochures
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Analytical Development & Characterization For AAV
Our assay packages and phase-appropriate assay development and validation capabilities provide the product and process knowledge you need to develop a QTPP and identify the CQAs for your therapy.
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Optimization Of Benzonase® Endonuclease Use In Virus Purification
The use of Benzonase® endonuclease additionally increases the yield in virus purification, protects the downstream chromatography and filter devices from fouling and reduces feed stream viscosity. In this document we will provide you guidance on how to plan and set up a Design of Experiments (DoE) optimization experiment of Benzonase® endonuclease in your viral gene therapy process.
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Adeno-Associated Virus (AAV) Biosafety Testing & Characterization Services
Biosafety testing and characterization for new products are essential as they emerge for clinical study. Both measures will help mitigate safety concerns and confirm product quality before these therapies are administered to patients. Our BioReliance® AAV testing services give you the confidence to get your products to market quickly and safely.
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Cellvento® 4CHO-X Brochure
The new Cellvento® 4CHO-X Expansion Medium supports cell expansion including N-1 perfusion for Chinese Hamster Ovary (CHO) cell lines.
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Medium For Producing High AAV Titers In Multiple HEK293 Cell Lines
Discover a chemically defined medium optimized for AAV production that has been streamlined and cell culture media components incorporated to increase media stability and reduce protein oxidation.
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Bio4C Orchestrator™ Software Data Integrity Assessment
Here, we describe Bio4C Orchestrator's™ adherence to the Food and Drug Administration’s (FDA) data integrity guidance set out in Data Integrity and Compliance with Drug CGMP Questions and Answers Guidance for Industry published December 2018.
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A Transfection-Based Solution With Proven Performance At Scale
The VirusExpress® 293 AAV Production Platform offers a transfection-based solution using a suspension-adapted cell line, which is GMP banked and characterized chemically defined medium, and a process with proven performance at a clinically relevant scale.