---
title: "Build it Right: A Quality Perspective on the Design and Build of a Viral Vector CDMO Manufacturing Facility"
description: In this webinar, learn why facility design to support the manufacturing of advanced therapies is fundamentally important to the success of those projects.
---

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# Build it Right: A Quality Perspective on

# the Design and Build of a Viral Vector

# CDMO Manufacturing Facility

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## Presenter:

****![10-31-2023-Avid-ATE-Speaker-HS-Cropped](https://bpi.bioprocessintl.com/hs-fs/hubfs/10-31-2023-Avid-ATE-Speaker-HS-Cropped.png?width=145&height=204&name=10-31-2023-Avid-ATE-Speaker-HS-Cropped.png)**Chris Berger**

*Executive Director, Quality Viral Vector,*

Avid Bioservices

 

Chris Berger joined Avid Bioservices in 2015 and is responsible for quality assurance for all cell and gene therapy products produced at Avid. Berger brings over 20 years of experience in various aspects of quality control and quality assurance to the Avid team.

 

In addition to a strong quality background, Berger has extensive experience in the development, validation, and transfer of analytical methods used to support manufacturing. As part of the design and build team for Avid’s new viral vector manufacturing facility, Berger provide quality and regulatory oversight to ensure a world class and compliant manufacturing facility.

## About this event:

#### Date: October 31, 2023

#### Time: 11 am EST | 8 am PST |

#### 5 pm CET

#### Duration: 30 minutes

The design and build of a facility to support the clinical and commercial manufacturing of advanced therapies is fundamentally important to the success of those projects. In many cases, a retrofit of an existing mammalian therapeutic manufacturing facility may introduce an unreasonable amount of risk into the manufacturing processes for advanced therapies, which can end up delaying the commercialization of such therapies.

Constructing a new facility can often alleviate these concerns, provided that engineering and process controls are designed properly to support manufacturing in a CDMO environment, which often has special considerations including the ability to handle multiple cell lines, virus families, and client projects.

In addition to those specific design requirements, CDMO manufacturing also places a unique demand on the facility with respect to visitors, person in plant, and the monitoring of critical process steps.

In all cases, the introduction of quality risk management principles early in the design phase allows for best practice controls that can be implemented to ensure product quality, minimize contamination, and ensure success in bringing new therapies to market.

An effective initial design review and periodic change review from all stakeholders, including the quality assurance team, during the progress of the build can allow for a facility to be commissioned that is right the first time.

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