Articles by Tyler Menichiello
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FDA Releases Draft Guidance To Accelerate Biosimilar Development
10/31/2025
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.
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Supporting The Next Generation Of ADCs
10/30/2025
Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."
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AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
10/10/2025
At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.
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On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
9/29/2025
AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.
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On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
9/26/2025
Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.
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On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.
9/25/2025
DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.
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Single-Use Standardization Starts At Home
8/28/2025
During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.
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Unlocking The Pharmacological Potential Of Antibodies
8/20/2025
Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains the company's Functional Antibody Selection Technology (FAST) platform and its approach to developing a pipeline of G protein-coupled receptor (GPCR) mAbs.
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How Lumen Is Putting The "Farm" In Biopharma
7/31/2025
Lumen Bioscience's SVP of production and development, Craig Behnke, Ph.D., explains how the company is cutting costs and rethinking upstream manufacturing with its algae-based production platform.
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The Safety Potential Of Conditionally Active Biologics
7/28/2025
Conditionally active biologics (CABs) are an emerging class of therapies that can reduce off-target toxicity in the clinic, and they were a topic of conversation at the 2025 BIO International Convention.