Bioburden Control Strategies for Continuous Downstream Processing
Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of…
Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture
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Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process
Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include…
Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent
A guest blog by Catherine Allioux, Global Product Manager, Chromatography Sorbents & Membranes, Pall Life Sciences In today’s market, mAbs…
Scalable Protein A Chromatography for High-Throughput Process Development
Process development is a critical part of biomanufacturing, but it can be very time and resource intensive. With recent industry…
Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule
Biosimilar molecules have some unique manufacturing requirements that must be taken into account when planning process development. The requirements for…
Designing a Viral Clearance Study – A Step by Step Tutorial
Viral clearance testing is a regulatory requirement and critical part of the overall approval process for all biologics. Viral clearance…
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Weekly Wrapup
August 4, 2017
Headlines: “What Does Your Microbiome Say About You?,” The New York Times “There are trillions of…
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Verifying Removal of Residual Production Enzymes from Your Final Product
Enzymes such as Trypsin and Collagenase are often critical components for product processing, modification of proteins…
Podcasts
Start With the End in Mind – How to facilitate transfer from non-GMP to GMP Manufacturing
In this podcast and accompanying article, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare…
Cool Tools
Cool Tool – Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing
Diafiltration, while fulfilling several functions in protein purification, has also presented a major obstacle in achieving…
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