Vol 10 Issue 3

CELL AND GENE THERAPY INSIGHTS

Vol 10 Issue 3

Cell and Gene Therapy Insights Vol 10 Issue 3

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Featuring

Issue Spotlight: Vector processing and materials
Scaling the supply chain 2024
Other articles
Webinars

Vector processing and materials

Chia Chu

Guest Editor:

Chia Chu, Director, AAV Process Development at Intellia Therapeutics

Francesca Vitelli

Guest Editor:

Francesca Vitelli, VP, Cell Therapy and AAV Process Development at Intellia Therapeutics

Expert Insight

Are we there yet? After 250+ AAV-based clinical trials, do we have a well-paved road toward first-in-human entry?

Are we there yet? After 250+ AAV-based clinical trials, do we have a well-paved road toward first-in-human entry?

Long Chen, Chia Chu, Francesca Vitelli

Improving process efficiency to reduce cost-of-goods per dose in manufacturing of recombinant AAVs

Improving process efficiency to reduce cost-of-goods per dose in manufacturing of recombinant AAVs

G Thakur, S Mink, H Bak et al.

Innovator Insight

Accelerating AAV process development with a PAT-driven TFF system

Accelerating AAV process development with a PAT-driven TFF system

AAV capsids separation is critical for advancing gene therapies

AAV capsids separation is critical for advancing gene therapies

Timotej Žvanut, Andreja Gramc Livk, Aleš Štrancar

Trends in innovation for downstream process intensification, product yield, single use closed systems, and gentle ATMP bioprocessing: a KOL panel discussing 2024 insights in gene therapy manufacturing

Trends in innovation for downstream process intensification, product yield, single use closed systems, and gentle ATMP bioprocessing: a KOL panel discussing 2024 insights in gene therapy manufacturing

Rachel Legmann, Andrew D Tustian

Expediting development and manufacturing of advanced therapies: critical starting materials case studies

Expediting development and manufacturing of advanced therapies: critical starting materials case studies

Commentary

Combining best practices and analytical reference materials to tackle challenges in AAV manufacturing

Combining best practices and analytical reference materials to tackle challenges in AAV manufacturing

FastFacts

Accelerate time to clinic for advanced therapies with a platform approach

Accelerate time to clinic for advanced therapies with a platform approach

John Lee, Cédrick Rousseaux, Dana Cipriano

Viewpoint

Best practices and considerations for outsourcing with CDMOs

Best practices and considerations for outsourcing with CDMOs

Joseph W Graskemper

Interview

Challenges and benefits in harnessing platform processes for viral vector manufacture

Challenges and benefits in harnessing platform processes for viral vector manufacture

Scott Cross, Christina Fuentes, Jacob Staudhammer

Delivering on a vision of a digitally enabled future for viral vector manufacturing

Delivering on a vision of a digitally enabled future for viral vector manufacturing

Sönke Brunswieck, Tania Chilima

Harnessing producer cell lines and process intensification to address the AAV process productivity conundrum

Harnessing producer cell lines and process intensification to address the AAV process productivity conundrum

Scaling the supply chain 2024

Expert Insight

Innovation in hematopoietic stem cell cryopreservation and cold chain management

Innovation in hematopoietic stem cell cryopreservation and cold chain management

M Prisciandaro, M Santodirocco, G Fania et al.

Interview

Achieving scalability: strategic insights into avoiding the pitfalls of the cell and gene therapy supply chain

Achieving scalability: strategic insights into avoiding the pitfalls of the cell and gene therapy supply chain

Journal articles

Innovator Insight

Evaluation and performance of an AAV affinity resin: a CDMO case study

Evaluation and performance of an AAV affinity resin: a CDMO case study

Spyros Gerontas, Buzz Lobbezoo

Viewpoint

Human capital comes with a memory

Human capital comes with a memory

Helena Strigard

2024: the year of the genome editing technologies?

2024: the year of the genome editing technologies?

Harriet Edwards

Interview

Insights into advanced therapies in the context of evolving funding and M&A environments

Insights into advanced therapies in the context of evolving funding and M&A environments

Expediting development and manufacture of advanced therapies: critical starting materials case study

Expediting development and manufacture of advanced therapies: critical starting materials case study

Andrew Frazer

Improving AAV productivity and packaging efficiency for transient and producer cell lines through plasmid engineering

Improving AAV productivity and packaging efficiency for transient and producer cell lines through plasmid engineering

Lisa Prendergast

5-day release strategies for autologous CAR-T Phase I products

5-day release strategies for autologous CAR-T Phase I products

Catherine Willis, Pavle Matak

Navigating CAR-T manufacturing: from research to GMP readiness

Navigating CAR-T manufacturing: from research to GMP readiness

Increasing efficiency in AAV-based gene therapy production: platform optimization with multiserotype AAV affinity capture

Increasing efficiency in AAV-based gene therapy production: platform optimization with multiserotype AAV affinity capture

Nicolas Laroudie, Tiago Albano

Commercial-scale manufacture of lentivirus for ex vivo and in vivo therapies

Commercial-scale manufacture of lentivirus for ex vivo and in vivo therapies

Rachel Legmann, Michelle Yen Tran

Alternative solutions to separate AAV full and empty capsids using anion exchange

Alternative solutions to separate AAV full and empty capsids using anion exchange

Åsa Hagner-McWhirter, Mark Schofield

Overcoming AAV aggregate analysis challenges using a novel size exclusion column to determine CQAs

Overcoming AAV aggregate analysis challenges using a novel size exclusion column to determine CQAs

Shilin Cheung, Ramkumar Dhandapani

Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Sharon Rouw, Michael Brewer

CAR-T manufacturing intensification: the next wave of CAR-T commercialization

CAR-T manufacturing intensification: the next wave of CAR-T commercialization

A Bersenev, E Kleiren, J Knighton et al.

Can primary packaging selection help mitigate particulate risks in cell and gene therapy manufacturing?

Can primary packaging selection help mitigate particulate risks in cell and gene therapy manufacturing?

S Werner, S Curbishley, J Jendusa

Considerations to optimize and act upon long-term follow-up studies for cell and gene therapies

Considerations to optimize and act upon long-term follow-up studies for cell and gene therapies

K Wonnacott, L Pelloso, D Takefman et al.

Increased productivity in the analytical testing of AAV titers with an automated immunoassay platform

Increased productivity in the analytical testing of AAV titers with an automated immunoassay platform

E Feeley, M Gianneli, J Venet

Optimizing access to high quality, standardized, and compliant leukopaks for the development and commercialization of allogeneic therapies

Optimizing access to high quality, standardized, and compliant leukopaks for the development and commercialization of allogeneic therapies

Makensie Becker

Overcoming the limits of lentivirus: de-risk cell therapy development with non-viral genome engineering

Overcoming the limits of lentivirus: de-risk cell therapy development with non-viral genome engineering

Miles Smith

Accelerate the scale-up to clinical phase: optimizing stem cell culture performance and viral vector titers

Accelerate the scale-up to clinical phase: optimizing stem cell culture performance and viral vector titers

Sara Bursomanno

Mastering AAV production: best practices For small- to large-scale manufacturing success and reduced development time

Mastering AAV production: best practices For small- to large-scale manufacturing success and reduced development time

Emily Jackson-Holmes

It’s a match: cell line engineering for AAV manufacturing expands the options for therapeutic programs

It’s a match: cell line engineering for AAV manufacturing expands the options for therapeutic programs

Dovilé Woods