From The Editor
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Integrating Analytics And Automation In Cell Therapy Manufacturing
7/31/2024
Experts from last month’s Cell & Gene Live event discuss practical ways to utilize emerging technologies.
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The Patchwork Of Outsourced ADC Manufacturing
7/29/2024
Antibody-drug conjugate (ADC) manufacturing is complicated, to say the least, and it relies on a diversity of expertise. In a recent Bioprocess Online Live event, Chief Editor Matt Pillar talks with expert panelists about how this unique modality requires unique manufacturing considerations.
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BPSA's Single-Use Summit Celebrates Its "Stainless" Anniversary
7/29/2024
The Bio Process Systems Alliance (BPSA) is devoted to the advance of single-use technologies in biopharmaceutical manufacturing. At its 11th International Single-Use Summit, the explosive growth in single-use was on full display, and the sourcing, safety, sustainability, and application discussions on the agenda were comprehensive.
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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 T/NK 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?