Better Biopharma

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Susan Sharfstein, Ph.D., a professor of nanoscale science and engineering at the University at Albany’s College of Nanotechnology, Science, and Engineering. They discuss Sharfstein’s research that focuses on using microRNA and structurally interacting RNA for faster and more efficient clonal cell line selection.

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Will Olughu, Ph.D., global CMC lead and senior principal scientist at Ipsen, to talk about process modeling and AI applications in biopharma manufacturing. Olughu explains the distinction between static process models and dynamic digital twins, as well as the challenges of implementing digital twins in GMP environments (from data interoperability to model validation and regulatory considerations).

Watch Olughu’s recent appearance in a Bioprocess Online Live event on ensuring successful technology transfer in ADC development: https://www.bioprocessonline.com/doc/ensuring-successful-technology-transfer-in-adc-development-0001

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In this episode of "Better Biopharma," host Tyler Menichiello is joined by Tonix Pharmaceuticals' chief technical officer, Siobhan Fogarty, to discuss the planning and construction of its manufacturing facility in Dartmouth, MA, which was purpose-built for the production of its horsepox-based live viral vaccine platform, TNX-801. Fogarty details the design process and the challenges Tonix faced in the facility's construction, specifically highlighting the long equipment lead times and supply chain constraints as a result of the COVID-19 pandemic.

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by former FDA staffers Eva Temkin, partner at Arnold & Porter, and Elizabeth Trentacost, senior associate at Arnold & Porter. They reflect on 2026 regulatory developments and discuss the implications and nuances of Operation TrialBlazer.

Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance. They discuss cell and gene therapy (CGT) manufacturing and the importance of maintaining quality unit independence within organizations, as well as some recent compliance violations at established manufacturing facilities. When it comes to CGT production, Matveeva advocates for a quality-by-design approach to protect patients and ensure compliance with regulatory requirements.

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Deck Bio’s chief scientific officer, Johanna Kaufmann, to discuss the company’s multi-peptide-MHC-targeted T-cell engager platform for solid tumors. Kaufmann explains the platform and reflects on the company’s journey through preclinical development.

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nathalie Clément, Ph.D., Siren Biotechnology’s SVP of vector development. The two discuss the historical challenges of purifying AAV vectors and the developments that have allowed for greater product yields. Clément shares where she believes the greatest gains can still be made to improve vector recovery and offers advice for teams seeking to optimize downstream unit operations.

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Kat Kozyrytska, a technology advisor and portfolio strategy leader. Kozyrytska shares her thoughts on how technology companies fit into the broader biopharma ecosystem. They discuss how AI is blurring the traditional boundaries between tech providers and therapeutics developers, as well as the increasing shift of tacit knowledge from human minds to the cloud. Kozyrytska also weighs in on how biotech companies should think about building, buying, or collaborating on AI platforms. 

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Jhong-Jhe You, Ph.D., VP of antibody discovery at AP Biosciences. You explains how molecular complexity and aspects of antibody design can influence a product’s manufacturability and developability.

Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/

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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by friend-of-the-show Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. Bozenhardt shares practical advice for teams planning a new biomanufacturing facility or retrofitting an existing one. He explains how thoughtful facility master planning can mitigate costly design mistakes and improve site flexibility, ensuring facilities remain adaptable to future technologies, new products, and evolving regulatory expectations.

Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/

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