BIO From The Editor and Guest Columns
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When In The Product’s Life Cycle Does Continuous Manufacturing Make Sense?
2/1/2024
This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.
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It's Time To Dethrone CHO When It Comes To mAb Production
2/1/2024
Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.
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Novel Approaches For Obtaining High-productivity Clones
1/30/2024
Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.
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Factors To Consider When Licensing An ADC Program
1/30/2024
Elevation Oncology's CEO and CSO explain what made the company's lead ADC candidate, EO-3021, worth licensing from Chinese pharmaceutical company, CSPC.
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Relational Risk Analysis For The Bio/Pharma Industry
1/29/2024
Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.
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Biotech Is Back With Allan Shaw
1/28/2024
The Business of Biotech took a trip to San Francisco for the JP Morgan Healthcare Conference, that most target-richest of environments for those of us who like talking shop with biotech builders. The results of that trip will feed the next several weeks of Business of Biotech podcast programming, and we're kicking things off with everyone's favorite life sciences CFO, Allan Shaw.
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Tangential Flow Filtration 101 — The Tech, The Need, And The Market
1/26/2024
Here's a high-level summary of what is increasingly becoming an essential part of the downstream bioprocessing production line.
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Picking The Best Virus Sample Prep Method In Process Development
1/26/2024
Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.
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21 New Downstream Technologies Being Considered To Fix Capacity Problems
1/25/2024
Downstream bottlenecks are a growing problem for legacy chromatography processes that can't keep pace with more robust upstream output. BioPlan has been tracking alternatives and discusses them here.
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FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance
1/25/2024
The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.