Behind the Batch | a Tozaro original series

Tozaro

Where we spotlight the moments that shape the people pioneering cell and gene therapy. Failed batches, first viable runs, tech transfers, and everything in between. Hosted by Alex Shephard, Head of Product at Tozaro.

Episodes

  1. 2d ago

    EP 5 - Matthew Hewitt (Charles River Laboratories )

    Summary In this episode, Matt Hewitt, Vice President and Chief Technical Officer of the Manufacturing Business Division at Charles River Laboratories, unpacks where cell and gene therapy manufacturing tends to break down. He explains why process scalability decides commercial success, how autologous and allogeneic approaches differ, and how academia and industry can work together to get therapies to patients faster. Keywords cell therapy, gene therapy, manufacturing, process development, biotech, biopharma, GMP, regulatory, industry standards, CDMO Key topics Common manufacturing failures in cell and gene therapyWhy scalable processes matter for commercial successHow academia and industry differ in therapy developmentRegulatory challenges and GMP standardsProcess development for biotech startups with limited runwayStandardisation and platforming in cell therapyAnalytical testing and release criteriaIndustry-wide bottlenecks and solutionsSound bites “Once good data is obtained, there’s a rush to go to market.”“The market for cell therapies is real and growing fast.”“Standardizing processes can accelerate therapy development.” Chapters 00:00 Introduction to Matt Hewitt and his background01:14 Common failures in cell and gene therapy manufacturing03:10 The challenge of process scalability for commercial production04:10 Differences between autologous and allogenic therapies06:24 Industry innovation and standardization challenges07:57 Revenue growth and manufacturing capacity in cell therapy09:14 Bridging the gap between academia and industry13:42 Advice for early-stage biotech process development17:19 Role of testing and GMP in therapy release22:59 Industry challenges in viral vector manufacturing27:28 Standardization and platforming in cell therapy27:50 How experienced partners can help biotech succeed Guest links Matt Hewitt on LinkedIn: https://www.linkedin.com/in/matthewmhewitt/Charles River Laboratories: https://www.criver.com

    EP 5 - Matthew Hewitt (Charles River Laboratories )

  2. Sep 25

    EP 4 - Ahmed Youssef (Ascend Advanced Therapies)

    SummaryAhmed Youssef, site head at Ascend Advanced Therapies in Munich, talks about his move from monoclonal antibodies into AAV gene therapy, what it takes to manufacture viral vectors at scale, and what a failed batch and years of tech transfers have taught him about process development. Keywordsgene therapy, AAV vectors, process development, tech transfer, biopharma manufacturing, quality control, scale-up, CGT challenges Key topicsAhmed Youssef's career trajectory in gene therapyEvolution of quality standards in AAV manufacturingChallenges in scaling gene therapy processesLessons learned from failed batches and troubleshootingBest practices for tech transfer across sites and geographiesDefining critical quality attributes in CGTImpact of process design on scalability and reproducibility Sound bites"This is genuinely life-changing what we do for these patients.""A very tiny, small thing could have an impact at the end, not even visibly like on the yield.""I've seen really tech transfers fail because just an operator missed the click on a button." Chapters00:00 Introduction and guest background01:12 Ahmed's journey into gene therapy and motivation02:09 Impact of gene therapy on patients and field evolution03:04 Changes in quality focus over the years03:56 Manufacturing complexities and individual application specifics04:58 Confidence in gene therapy despite industry ups and downs06:10 A memorable failed batch and lessons learned08:15 Troubleshooting copper residues in upstream process11:12 Tech transfer challenges and best practices16:21 Scaling processes from development to manufacturing19:47 Defining and measuring critical quality attributes23:01 Mentorship and support for industry newcomers Guest linksAhmed Youssef on LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssef/Ascend Advanced Therapies: https://www.ascend-adv.com/

    EP 4 - Ahmed Youssef (Ascend Advanced Therapies)

  3. Sep 24

    EP 3 - Jay Rosanelli (Syenex)

    SummaryIn this episode, Jay Rosanelli, Co-Founder and CEO of Syenex, shares his journey from neuropharmacology research to founding a biotech company focused on targeted delivery technologies for genetic medicines. We explore the challenges of biotech innovation, managing investor expectations and the future of delivery systems in gene therapy. Keywordsbiotech, gene therapy, targeted delivery, biotech innovation, venture capital, genetic medicines, in vivo delivery, ex vivo delivery, biotech startups, drug development, Syenex Key topicsJay Rosanelli's career transition from neuropharmacology to biotechThe importance of ecosystem building in biotech innovationChallenges of capital raising in biotech startupsTechnical failures and learning in drug delivery developmentFuture directions in in vivo delivery and payload engineeringThe role of synthetic biology in advancing biotech solutions Sound bites"The field of biopharma is very innovative in the science, but a little bit less innovative in business models.""There was no home for what I saw as highly impactful work that no one was doing.""Patients will always want the best delivery system for their therapeutic. You know, I don't think it'll ever be good enough." Chapters00:00 Introduction to Jay Rosanelli and Syenex01:16 Jay's career journey from research to investment banking03:38 Building a biotech in the genetic medicine space05:35 Balancing scientific breakthroughs with investor demands06:11 Overcoming delivery challenges in drug development08:17 Innovations in payload engineering and targeted gene integration10:18 Early proof of concept and third-party validation12:46 From academic lab to scalable biotech production16:06 Managing scientific risk and investor expectations17:07 Supporting biotech entrepreneurs and future collaborations Guest linksJay Rosanelli on LinkedIn: https://www.linkedin.com/in/jdrosanelli/Syenex: https://www.syenex.com/

    EP 3 - Jay Rosanelli (Syenex)

  4. Aug 26

    EP 2 - Giuliana Vallanti (AGC Biologics)

    Giuliana Vallanti shares her experience in cell and gene therapy, covering process development, tech transfer and the innovations behind scalable, reliable manufacturing. Key topics - Scaling viral vector manufacturing from lab to industry - Critical factors for successful tech transfer - Early development work and risk mitigation - Advances in lentiviral vector production and scalability - The role of potency assays in product characterisation Chapters 00:00 Introduction to Giuliana Vallanti and her background 10:00 Giuliana's journey into cell and gene therapy 13:02 Lessons learned from early challenges in gene therapy 17:00 Milestones in lentiviral vector manufacturing 19:55 Tech transfer: success factors and common pitfalls 25:54 The importance of comprehensive process understanding 27:02 Key analytical methods and potency assays 29:47 Innovations in vector production technologies 32:11 Final thoughts on advancing cell and gene therapy manufacturing Resources Tozaro - https://www.tozaro.com AGC Biologics - https://www.agcbio.com/ Asimov - https://www.asimov.com/ Lentiviral vector manufacturing - https://www.agcbio.com/technologies/lentiviral-vector Gene of interest feasibility approach - https://www.agcbio.com/approach/GOI-feasibility

    EP 2 - Giuliana Vallanti (AGC Biologics)

  5. Aug 3

    EP1 - Andre Raposo (OXB)

    content type Interview primary goal Educational summary In this episode, Andre Raposo shares his journey from fundamental HIV research to leading innovation in viral vector manufacturing at OXB. We explore the integration of automation, AI, and data-driven approaches in cell and gene therapy development, along with lessons learned from failures and successes. keywords gene therapy, viral vectors, automation, AI, biotech innovation, process development, GMP, data analytics, CDMO, bioprocessing key topics Andre Raposo's career transition from academia to industry The role of automation and AI in GMP manufacturing Common causes of failure in process development and how to learn from them The importance of team and culture in successful tech transfer Future trends in cell and gene therapy manufacturing guest name Andre Raposo sound bites "Automation amplifies existing processes, good or bad" "AI can help automate boring tasks and expedite analysis" "Never make assumptions, let the data tell the story" Chapters 00:00 Introduction to Andre Raposo and his background 00:52 Andre's transition from HIV research to gene therapy process development 04:24 Innovating at OXB: automation, analytics, and AI 06:31 Debunking myths about automation in CGT manufacturing 11:39 A failed experiment: lessons learned and the importance of biology 14:55 The value of failed experiments in leadership and science 17:43 Building computer-aided biology at OXB 22:18 Successful tech transfer and challenges in GMP implementation 26:11 Capturing tacit knowledge and ensuring smooth handoffs resources Oxford Biomedica (OXB) - https://www.oxb.com/ Design of Experiments (DOE) - https://en.wikipedia.org/wiki/Design_of_experiments Hamilton Liquid Handlers - https://www.hamiltoncompany.com/ Unchained Labs - https://www.unchainedlabs.com/ guest links LinkedIn - https://www.linkedin.com/in/andre-raposo/ Twitter - https://twitter.com/andre_raposo

  • 5 Episodes

About

Where we spotlight the moments that shape the people pioneering cell and gene therapy. Failed batches, first viable runs, tech transfers, and everything in between. Hosted by Alex Shephard, Head of Product at Tozaro.

Information