CELL & GENE THERAPY INSIGHTS

Process Development & cGMP Manufacturing hub

Process development is the foundation for the successful commercialization of cell and gene therapies. The complexities of CGT manufacturing necessitate a step-by-step approach to developing robust, reproducible, and commercially viable processes in a phase-appropriate and streamlined manner. Harnessing scalable cGMP manufacturing platform technologies whilst maintaining flexibility in process development is a critical focus for the CGT manufacturing field as a whole.

This collection of curated content from Lonza explores the key role of process development in establishing a clear path to successful commercial cGMP manufacture of advanced therapies.

Content

Industrialization of AAV manufacturing with Xcite® transient and stable production platforms

Industrialization of AAV manufacturing with Xcite® transient and stable production platforms

Suparna Sanyal, Peng Wang
19 March
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How will process development and analytical innovation drive growth for the future of cell and gene therapies?

How will process development and analytical innovation drive growth for the future of cell and gene therapies?

Mark Santos
7 October 2024
Innovator Insight
Enhancing CAR-T therapy development: harnessing cell selection flexibility

Enhancing CAR-T therapy development: harnessing cell selection flexibility

Tamara Laskowski, Nuala Trainor
2 October 2024
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Extracellular vesicles: setting-up the path to IND with advanced characterization packages

Extracellular vesicles: setting-up the path to IND with advanced characterization packages

Davide Zocco
28 August 2024
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Revolutionary innovations are underway to industrialize cell and gene therapies

Revolutionary innovations are underway to industrialize cell and gene therapies

Mark Santos
13 June 2024
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Rapid CAR-T cells: accelerating manufacturing to enable fast transition of CAR-T cell therapies to the clinic

Rapid CAR-T cells: accelerating manufacturing to enable fast transition of CAR-T cell therapies to the clinic

Tamara Laskowski, Kelly Purpura
6 March 2024
Innovator Insight
Rapid CAR-T cells: Accelerating manufacturing to enable fast transition of CAR-T cell therapies to the clinic

Rapid CAR-T cells: Accelerating manufacturing to enable fast transition of CAR-T cell therapies to the clinic

Tamara Laskowski, Kelly Purpura
7 December 2023
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Establishing the standards of operational excellence to manufacture commercial cell therapies

Establishing the standards of operational excellence to manufacture commercial cell therapies

Melanie Mansbach, Hui Zheng
25 October 2023
Innovator Insight
Establishing the standards of operational excellence to manufacture commercial cell therapies

Establishing the standards of operational excellence to manufacture commercial cell therapies

Hui Zheng, Melanie Mansbach
24 August 2023
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Scale-up and delivery of allogeneic cell therapies to large patient populations

Scale-up and delivery of allogeneic cell therapies to large patient populations

Marcos Langtry, Krishna Panchalingam, Inbar Friedrich Ben-Nun
15 July 2023
Innovator Insight
Navigating bottlenecks in cell therapy manufacturing: A versatile and scalable platform solution

Navigating bottlenecks in cell therapy manufacturing: A versatile and scalable platform solution

Peter Yates
13 April 2023
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Scale-up and deliver allogeneic cell therapies to large patient populations

Scale-up and deliver allogeneic cell therapies to large patient populations

M Langtry, K Panchalingam, I Friedrich Ben-Nun
29 March 2023
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Industrialization of cell and gene therapies: process development best practices for commercialization readiness

Industrialization of cell and gene therapies: process development best practices for commercialization readiness

Behnam Ahmadian Baghbaderani
17 November 2022
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Process development excellence to de-risk & accelerate commercialization of cell & gene therapies

Process development excellence to de-risk & accelerate commercialization of cell & gene therapies

Behnam Ahmadian Baghbaderani
17 November 2022
Innovator Insight
Scalable suspension lentiviral vector production platforms for cGMP manufacturing

Scalable suspension lentiviral vector production platforms for cGMP manufacturing

Suparna Sanyal PhD
13 October 2022
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Overcoming quality and regulatory challenges to reliably take your cell & gene therapy to commercialization

Overcoming quality and regulatory challenges to reliably take your cell & gene therapy to commercialization

Andreas Wirth, Christoph Meyer
15 September 2022
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Autologous cell therapies - the path to commercial viability

Autologous cell therapies - the path to commercial viability

Joe Garrity
7 July 2022
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Process development excellence to de-risk and accelerate commercialization of cell and gene therapies

Process development excellence to de-risk and accelerate commercialization of cell and gene therapies

Behnam Ahmadian Baghbaderani
5 May 2022
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Introducing Lonza’s AAV suspension transient transfection platform to de-risk your path to clinic

Introducing Lonza’s AAV suspension transient transfection platform to de-risk your path to clinic

Suparna Sanyal
24 February 2022
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Magnetic selection for consistent cellular starting material in autologous cell therapy manufacture

Magnetic selection for consistent cellular starting material in autologous cell therapy manufacture

Kenneth Olsen PhD, Rachel Perret PhD
23 November 2021
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GMP manufacturing for exosome-based therapies: the critical role of analytics and process design for clinical production and scale-up

GMP manufacturing for exosome-based therapies: the critical role of analytics and process design for clinical production and scale-up

Marcos Langtry, Davide Zocco
28 September 2021
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Delivering an end-to-end industrialization roadmap for autologous cell therapy

Delivering an end-to-end industrialization roadmap for autologous cell therapy

M Hewitt PhD, J Garrity, W Bagni
6 July 2021
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Scalable suspension LVV production platforms for cell and gene therapy

Scalable suspension LVV production platforms for cell and gene therapy

S Sanyal, M Haller, Y Shin
13 April 2021
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The right time to move to an automated manufacturing system like the Cocoon platform: the when, the why, and the how

The right time to move to an automated manufacturing system like the Cocoon platform: the when, the why, and the how

Matthew Hewitt, Donna Rill
3 December 2020
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Focus on allogeneic CAR-Ts manufacturing challenges and solutions

Focus on allogeneic CAR-Ts manufacturing challenges and solutions

M Langtry, A Sargent, B Ahmadian Baghbaderani
5 November 2020
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Scalable commercial manufacturing: a key strategic element for success of next generation exosome-based cell-free therapies

Scalable commercial manufacturing: a key strategic element for success of next generation exosome-based cell-free therapies

Behzad Mahdavi MBA PhD, Senthil Ramaswamy
24 September 2020
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Identifying the critical factors for commercial-scale viral vector process development and manufacturing

Identifying the critical factors for commercial-scale viral vector process development and manufacturing

B Ahmadian Baghbaderani, X Swanson, S Sanyal
26 August 2020
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Enabling the industrialization of human induced pluripotent stem cell-based therapies

Enabling the industrialization of human induced pluripotent stem cell-based therapies

K Panchalingam, I Friedrich Ben-Nun, M Langtry
4 June 2020
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Key steps to industrialize your process and de-risk your pathway to commercialization in cell and gene therapy

Key steps to industrialize your process and de-risk your pathway to commercialization in cell and gene therapy

Behnam Baghbaderani
21 November 2019
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A bespoke solution to cell therapy manufacturing: the Cocoon platform

A bespoke solution to cell therapy manufacturing: the Cocoon platform

Matthew Hewitt
26 September 2019
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Enabling the next level of pluripotent stem-cell based therapies, from bench to commercialization

Enabling the next level of pluripotent stem-cell based therapies, from bench to commercialization

Puspa Pandey, Fan Yang
13 June 2019
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Latest advances in automated platforms for autologous cell & gene therapy manufacturing

Latest advances in automated platforms for autologous cell & gene therapy manufacturing

E Abraham, D Kuijstermans, Y Shi
25 October 2018
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Making it happen: the road to commercial scale cell therapy manufacturing

Making it happen: the road to commercial scale cell therapy manufacturing

Y Levinson, T Richardson, I Friedrich Ben-Nun
27 September 2018
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Development & manufacture of next-generation viral vectors for gene therapy

Development & manufacture of next-generation viral vectors for gene therapy

Anandita Seth
20 June 2018
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