---
title: "Decoding AAV: Navigating Critical Quality Attributes and Their Analytics - Unveiling Opportunities in Biomanufacturing"
description: In this webinar, learn about key pre-quality attributes in AAV manufacturing and the cognate landscape of technologies analyzing them.
---

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# Decoding AAV Manufacturing:

# Navigating Critical Quality Attributes

# and their Analytics

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## Presenter:

****![10-10-2024-Roche-ATE-Speaker-HS-Cropped](https://bpi.bioprocessintl.com/hs-fs/hubfs/10-10-2024-Roche-ATE-Speaker-HS-Cropped.png?width=145&height=204&name=10-10-2024-Roche-ATE-Speaker-HS-Cropped.png)**Roland Pach, PhD**

*Global Analytical Expert, CMC, CGT, & Alternative Formats,*

Roche

 

Roland Pach, PhD holds a doctoral degree in molecular parasitology from the University Fribourg, where he analysed the intracellular trafficking of transgenic RNA in trypanosomes.

 

Prior to Roche, he was leading a DiTe vaccine manufacturing unit followed by building up the Analytical Development Department of Vaccines at Berna Biotech (now Jansen Vaccine).

 

As department head of Analytics Bioprocess Development at Merck-Serono, he supported with his team the process development activities and process characterization of late stage projects of fusion proteins and interleukins drug candidates.

 

At Roche, Roland is the global CMC analytical technical lead in the cancer vaccines and cell and  gene therapy (CGT) area for more than 15 years. In his assigned area, he represents Roche-Genentech in external development projects, at industrial consortia like CGT BioPhorum and at numerous successful due diligence projects of in-licensing candidates or at merger of companies in the CGT fields. As editor and author at Springer Nature, he published several white papers and articles describing the current challenges of manufacturing and analysis of CGT drug products.

 

In his second role at Roche as global technical development leader, he successfully led new formats like immunotoxins from pre-clinics into entry to human (EiH, Phase 1).

 

## About this event:

#### Date: October 10, 2024

#### Time: 11 am EDT | 8 am PDT |

#### 5 pm CEST

#### Duration: 15 minutes

Gene therapy based therapeutics offer revolutionary ways of treating and curing genetic disorders. CMC plays a crucial part, however it is faced with complex manufacturing processes and the intrinsic complexity of the genetic therapeutics themselves.

In this webinar, learn about key pre-quality attributes in AAV manufacturing and the cognate landscape of technologies analyzing them. There is a high need for more sophisticated methods for improving and deepening the understanding of the process and product.

Key Takeaways:

- **Complexities in AAV Manufacturing**  
    - Explore the intrinsic complexities and critical pre-quality attributes in the Adeno-associated Virus (AAV) manufacturing process.
- **Empty versus Full Virus Particles**  
    - Understand the challenges and significance of differentiating between “empty” and “full” virus particles in ensuring product quality.
- **Analytical Technology Landscape** 
    - Review the evolving landscape of analytical tools and highlight the urgent need for more sophisticated methods to improve process and product understanding.

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