From The Editor
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Manufacturing CAR-T In Vivo
7/25/2024
Manufacturing chimeric antigen receptor (CAR) T-cell therapies is a costly and complicated process. Interius BioTherapeutics is on a mission to reduce this complexity and get these therapies to patients faster — by manufacturing CAR cells in patients' bodies.
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Temperature & Containment Controls In ADC Manufacturing
7/19/2024
During a Bioprocess Online Live discussion with leaders from a couple of biotechs with Phase 1 ADC assets in the clinic, an audience member asked questions about OEB (occupational exposure bands) and managing the elevated temperatures required of ADC conjugation. We couldn't address them on the call, but here are some resources that might be helpful.
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The Path To Producing An Insulin Biosimilar
7/17/2024
I met with rBIO co-founder and president, Cameron Owen, as well as its CSO, Dr. Deenadayalan Bakthavatsalam, to learn about what it takes to develop an insulin biosimilar. They candidly told me about the company’s plan of execution, as well as how challenging it is to scale-up manufacturing to a commercial level (in the ballpark of several metric tons per year for insulin) — which is the company’s primary focus right now.
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Inside Barinthus Biotherapeutics' Combination Immunotherapy Platform
6/28/2024
In this Q&A with Barinthus Biotherapeutics' CEO, Bill Enright, he tells Bioprocess Online about the company's combination immunotherapy platform and its mission to develop a curative treatment for hepatitis B.
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Antibodies, Linkers, An Uber, And John Wick
6/28/2024
The challenges faced by ADC developers after a hundred-year history with the basic concept of the drug makes the recent billion-dollar bets on the modality look all the more dramatic. What gives? Where’s all this confidence coming from? It's not the antibody. It's not the payload. It's the linker.
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Scale And Sustainability In Single-Use Systems
6/13/2024
I had the opportunity to cover a lot of ground on considerations for single-use technologies in biopharmaceutical manufacturing with Mark Petrich, Ph.D. when he joined me as a guest expert on the Bioprocess Online Live event Single Use Technologies For Bioprocessing: An Essential Update. Here are some of his insights on single-use scale and lifecycle management.
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Where's The Case For Generative AI In Biopharmaceutical Manufacturing?
6/12/2024
The early use cases for AI in the biopharmaceutical industry—at least, the early public use cases—have largely come from R&D, and more specifically, target identification and molecular design. Where are the use cases in biologics manufacturing, supply chain management, QMS, and operations, and what’s holding us back?
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Bioprocessing Technology: You Are The Standard
5/21/2024
Single-use bioprocessing equipment engineer and expert Paul Priebe has some advice for you. Next time you catch yourself questioning an equipment standard (or the lack thereof), take a good look in the mirror.
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7 Bioprocess Intensification Strategies
4/23/2024
“Process intensification” is one of those big umbrella terms that unfairly implies a concept that comes with an instruction manual. It doesn’t. It isn’t prescriptive. It doesn’t have to start in a specific place, and it really never ends.
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Single Use In Biopharma: Beyond Savings & Sustainability
4/17/2024
SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. We dove headlong into those issues and more with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.