Summary
Ahmed 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.

Keywords
gene therapy, AAV vectors, process development, tech transfer, biopharma manufacturing, quality control, scale-up, CGT challenges

Key topics
Ahmed Youssef's career trajectory in gene therapy
Evolution of quality standards in AAV manufacturing
Challenges in scaling gene therapy processes
Lessons learned from failed batches and troubleshooting
Best practices for tech transfer across sites and geographies
Defining critical quality attributes in CGT
Impact 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."

Chapters
00:00 Introduction and guest background
01:12 Ahmed's journey into gene therapy and motivation
02:09 Impact of gene therapy on patients and field evolution
03:04 Changes in quality focus over the years
03:56 Manufacturing complexities and individual application specifics
04:58 Confidence in gene therapy despite industry ups and downs
06:10 A memorable failed batch and lessons learned
08:15 Troubleshooting copper residues in upstream process
11:12 Tech transfer challenges and best practices
16:21 Scaling processes from development to manufacturing
19:47 Defining and measuring critical quality attributes
23:01 Mentorship and support for industry newcomers

Guest links
Ahmed Youssef on LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssef/
Ascend Advanced Therapies: https://www.ascend-adv.com/

Summary
In 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.

Keywords
biotech, gene therapy, targeted delivery, biotech innovation, venture capital, genetic medicines, in vivo delivery, ex vivo delivery, biotech startups, drug development, Syenex

Key topics
Jay Rosanelli's career transition from neuropharmacology to biotech
The importance of ecosystem building in biotech innovation
Challenges of capital raising in biotech startups
Technical failures and learning in drug delivery development
Future directions in in vivo delivery and payload engineering
The 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."

Chapters
00:00 Introduction to Jay Rosanelli and Syenex
01:16 Jay's career journey from research to investment banking
03:38 Building a biotech in the genetic medicine space
05:35 Balancing scientific breakthroughs with investor demands
06:11 Overcoming delivery challenges in drug development
08:17 Innovations in payload engineering and targeted gene integration
10:18 Early proof of concept and third-party validation
12:46 From academic lab to scalable biotech production
16:06 Managing scientific risk and investor expectations
17:07 Supporting biotech entrepreneurs and future collaborations

Guest links
Jay Rosanelli on LinkedIn: https://www.linkedin.com/in/jdrosanelli/
Syenex: https://www.syenex.com/

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

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