Establishing the standards of operational excellence to manufacture commercial cell therapies
Aug
24
2023
On demand

Establishing the standards of operational excellence to manufacture commercial cell therapies

Thursday 07:00 PDT / 10:00 EDT / 15:00 BST / 16:00 CEST
Sponsor
Establishing the standards of operational excellence to manufacture commercial cell therapies

After entering Phase 3, cell and gene therapies experience nearly five times more discontinuations or significant delays due to CMC issues than monoclonal antibodies. The highly manual processes, lack of robust analytical methods, and lack of quality standards are often the cause and pose challenges in meeting the appropriate cGMP manufacturing standards required by regulators.

During this webinar, two of Lonza’s operational excellence team will share the secrets behind recent successes in commercializing and producing commercial cell and gene therapies.

  • Establishing the standards of everyday operational excellence for commercial manufacturing
  • Harmonizing processes and methods across sites and assets
  • Continuous improvement: training, re-training, and tracking to maintain and improve standards
Hui Zheng
Hui Zheng
Head of CGT Operations at Lonza Singapore

Hui Zheng joined Lonza in 2021 and is currently serving as the Head of Operations, CGT at Lonza Singapore. She drives operational excellence and ensures top-quality manufacturing processes. With extensive experience and leadership roles at Novartis, including Head of Project Management Office and Head of operational excellence, Hui has a proven track record of successful project execution. Her Master's degree in Biochemical Engineering from Tianjin University added a solid academic foundation to her practical expertise. Known for her dedication and innovation, Hui Zheng continues to make significant contributions to advancing Cell & Gene therapies.

Melanie Mansbach
Melanie Mansbach
Head of Cell Therapy Manufacturing at Lonza Houston

Melanie Mansbach is a dedicated leader with a career spanning over 15 years, including experience in cell and gene therapy manufacturing and in the U.S. Army. As the Head of Cell Therapy Manufacturing at Lonza Houston, she leads a 250-person team in the production of cell therapy products under cGMP. Her expertise in this specialized field, coupled with her proven track record of team development and process improvement, has consistently delivered outstanding results. Melanie's exceptional leadership and deep knowledge of cell and gene therapy manufacturing continue to drive transformative advancements in the industry.

SPEAKERS

Hui Zheng
Hui Zheng
Head of CGT Operations at Lonza Singapore
Melanie Mansbach
Melanie Mansbach
Head of Cell Therapy Manufacturing at Lonza Houston

You might also like

Same-section spatial multiomics: a platform for detailed analysis of the solid tumor TME

Same-section spatial multiomics: a platform for detailed analysis of the solid tumor TME

Emily Neil, Ariadna Pascual
27 June
in 53
Days
Register
Specifications don’t tell the whole story: how to choose GMP process and QC equipment

Specifications don’t tell the whole story: how to choose GMP process and QC equipment

M Kay Bates, W Marin, K Whitlatch
18 June
in 44
Days
Register
Quadplex dPCR as a tool to analyze genome integrity and heterogeneity in gene therapy drug products

Quadplex dPCR as a tool to analyze genome integrity and heterogeneity in gene therapy drug products

Ryan Massopust
11 June
in 37
Days
Register
Precision in production: optimizing monitoring and quality control for high-value plasmids

Precision in production: optimizing monitoring and quality control for high-value plasmids

Oleksandr Karpenko
6 June
in 32
Days
Register
Advancing cell therapy: innovations in polymer-based encapsulation and delivery

Advancing cell therapy: innovations in polymer-based encapsulation and delivery

Y Brudno, O Veiseh, M Delic-Schlumbohm et al.
5 June
in 31
Days
Register