From The Editor
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Key Takeaways From The 2024 Bioprocessing Summit
8/26/2024
Editor Tyler Menichiello reflects on the topics and trends covered at this year's Bioprocessing Summit in Boston.
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The ADC Market Is Ripening For Disruption
8/21/2024
Where there is therapeutic demand, the industry will build capacity. But with ADCs, cytotoxic payloads and a fragmented contract manufacturing landscape make the path to clinical and commercial supply dauntingly complicated. Here's how the ADC manufacturing market is shaping up, and how it might ultimately shake out.
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Are You Taking The HPCs In Your ADCs Seriously?
8/16/2024
The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.
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Are Bioprocess Equipment Standards A One-Sided Conversation?
7/31/2024
Half of respondents to a recent survey of biopharmaceutical companies said the greatest challenge in further growing industry acceptance of single-use technology—which now comprises an eye-popping 85% of non-commercial-scale biopharma manufacturing infrastructure—is the greater challenge in further growing industry acceptance of single-use technology
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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.