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In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. Bozenhardt outlines his concerns with the current outsourcing environment, noting a rising rate of noncompliance driven by poor facility maintenance and a shortage of reliable workers. He offers advice to sponsor companies working with CDMOs to help ensure their assets don’t fall victim to poor partnerships and operational mismanagement. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance. They discuss Annex 22, the EMA’s GMP annex addressing the use of artificial intelligence (AI) in regulated manufacturing, including where it is sufficient and where it is lacking. Baker reflects on his time at the FDA and offers his own advice on AI and technology adoption and validation in GXP. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by fellow chief editors from across the Life Science Connect ecosystem to reflect on the year and share their industry outlooks for 2026. This editorial roundtable features Katie Anderson, chief editor at Pharmaceutical Online; Jeff Buguliskis, Ph.D., deputy chief editor at Outsourced Pharma; Ben Comer, chief editor at Life Science Leader and host of The Business Of Biotech podcast; Ray Dogum, chief editor at Drug Discovery Online; Erin Harris, chief editor at Cell & Gene and host of Cell & Gene: The Podcast; and Anna Rose Welch, chief editor at Advancing RNA. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tinglong Dai, Ph.D., Bernard T. Ferrari Professor of Business at Johns Hopkins University, and Tugce Martagan, Ph.D., associate professor at Northeastern University, to talk about the potential advancements that can be made in biomanufacturing by combining AI with operations research (OR). You can check out their recent paper on the subject, “Synergizing Artificial Intelligence And Operations Research For Advancements In Biomanufacturing,” here: https://link.springer.com/epdf/10.1007/s10729-025-09725-7?sharing_token=RsWPImKggnLuwsztf7Y1S_e4RwlQNchNByi7wbcMAY7x0AE_Vqj5xOwaldIl63JrPLRzcTIZn-7Iu6LEV-lGtfKrE2ZoADSYlnvcNAipmXCnruKMpDaS19yEPXSw9A0rbab6H57jkCX1EJOGdqO_VeCnwP3qw80LUT-QFcDzr58%3D  Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Sean Tucker, Ph.D., founder and chief scientific officer at Vaxart, a company developing oral recombinant pill vaccines. They discuss Vaxart’s manufacturing process and how it differs from traditional biopharmaceutical production, as well as the regulatory considerations around its oral vaccines. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of "Better Biopharma," Tyler Menichiello is joined by Patrick Bilbo, chief operating officer at Organogenesis, a regenerative medicine company developing and manufacturing advanced wound care products. They discuss the construction of Organogenesis's new facility in Rhode Island, as well as how the industry has changed in the company's 40-year history. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Bonum Therapeutics' chief scientific officer, Diane Hollenbaugh, Ph.D., and chief business officer, Neela Patel, Ph.D. They talk about the inherent challenges of developing complex molecules like conditionally active biologics, sharing advice on CMC strategy, analytical methodology, and working with contract manufacturing and development partners. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma. They also explain the unique CMC challenges around developing a safe bacterial vector. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Fiona Elwood, Ph.D., VP and Neurodegeneration Disease Area Stronghold Leader at Johnson & Johnson. The two talk about J&J’s end-to-end organizational structure and its modality-agnostic approach to treating Alzheimer’s disease. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nicole Paulk, Ph.D., CEO and founder of Siren Biotechnology, a company developing a universal AAV immuno-gene therapy for cancer. They discuss the company’s decision to switch from plasmids to producer cell lines (PCLs) in production, the current funding environment for cell and gene therapies (CGTs), how companies are innovating and doing more with less, and the unconventional head-to-head competition that determined which CDMO won Siren’s business. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Adaptin Bio's CEO, co-founder, and president, Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD. They discuss Adaptin's Brain Bispecific T-cell Engager (BRiTE) platform, its clinical potential to deliver therapeutic T cells across the blood-brain barrier, and the development and manufacturing challenges behind the company's lead asset, APTN-101.  Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of Better Biopharma, Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains how the company's functional antibody selection technology (FAST) platform differs from traditional affinity screening. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

How can the biopharmaceutical industry improve? Join Bioprocess Online's Tyler Menichiello as he explores this question through a series of interviews with experts and leaders from across the space. Subscribe for biweekly, in-depth conversations with the brightest minds in biotech to learn how they're moving the needle to make better medicines and optimize manufacturing. Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions