Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance
Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and…
Recent Posts
Top Downstream Process Articles of 2019
Don't miss our top articles on downstream processing for 2019! I have compiled a list of our most popular articles…
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Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint
Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most…
Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach
Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using…
Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L
A guest article by Yuji Okubo, Director, Pharmaceutical Unit, Kaneka US Innovation Center and Harkewal Singh, Manager- Pharmaceutical Unit, Kaneka…
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Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture
To ensure a safe and continuous supply of life-saving biopharmaceuticals, raw materials for biomanufacturing must be selected carefully and suppliers…
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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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