CELL & GENE THERAPY INSIGHTS

Download issue

Sep 2020. Vol 6 Issue 8

Sep 2020

FEATURING

Issue Spotlight: Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture
Focus: Biopreservation and cold chain management
Report: Regulatory Insights September 2020

Other articles
Webinars

Spotlight

Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture
Sep 2020
Guest Editor:
Jan Thirkettle
Jan Thirkettle, Chief Executive Officer at Transine Therapeutics
Jan Thirkettle
Jan Thirkettle
Chief Executive Officer at Transine Therapeutics

Foreword

Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture

Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture
Jan Thirkettle
29 September 2020
Foreword
Read more

Expert Insight

Scale-up vs scale-out: evaluating manufacturing scalability of CAR T cell therapy using process simulation tools

Scale-up vs scale-out: evaluating manufacturing scalability of CAR T cell therapy using process simulation tools
Apoorva Katragadda,
Iftekhar Karimi,
Xiaonan Wang
3 September 2020
Expert Insight
Read more

Innovator Insight

Scalable and efficient AAV production process with new Fibro chromatography technology

Scalable and efficient AAV production process with new Fibro chromatography technology
Laura Adamson-Small,
Mats Lundgren, PhD,
Peter Guterstam, MD
30 September 2020
Innovator Insight
Read more

Commentary

The power of small: success of small academic/healthcare units within the cell & gene therapy industry

The power of small: success of small academic/healthcare units within the cell & gene therapy industry
Benjamin Weil,
Owen Bain
24 September 2020
Commentary
Read more
Small labels, big challenges: solutions for advanced therapy labeling

Small labels, big challenges: solutions for advanced therapy labeling
Heidi Hagen,
Christophe Suchet
21 September 2020
Commentary
Read more

Interview

Delivering cell and gene therapies: evolving logistics considerations

Delivering cell and gene therapies: evolving logistics considerations
Adrian Lee-Mohan,
David Murphy
29 September 2020
Interview
Read more
A necessary transition: why viral vector production for gene therapy needs to evolve

A necessary transition: why viral vector production for gene therapy needs to evolve
Ryan Cawood
29 September 2020
Interview
Read more
Driving NK cell therapy manufacture to commercial scale

Driving NK cell therapy manufacture to commercial scale
Leonard Sender
23 September 2020
Interview
Read more

Podcast

Delivering cell and gene therapies: evolving logistics considerations - Podcast

Delivering cell and gene therapies: evolving logistics considerations - Podcast

Adrian Lee-Mohan,
David Murphy
29 September 2020
Podcast
Listen now

Expert Roundtable Video

Expert Roundtable: getting a gene therapy product to market: pitfalls and how to prevent them

Expert Roundtable: getting a gene therapy product to market: pitfalls and how to prevent them
Hetal Brahmbhatt,
Thomas Guarinoni,
Elizabeth Simmons
21 September 2020
Expert Roundtable Video
Watch now

Expert Roundtable

Expert Roundtable: getting a gene therapy product to market: pitfalls and how to prevent them

Expert Roundtable: getting a gene therapy product to market: pitfalls and how to prevent them
Hetal Brahmbhatt,
Thomas Guarinoni,
Elizabeth Simmons
29 September 2020
Expert Roundtable
Read more

FastFacts

TESSA technology: a new paradigm in AAV manufacturing

TESSA technology: a new paradigm in AAV manufacturing
Ryan Cawood
1 October 2020
FastFacts
Read more

Supply Chain FOCUS

Biopreservation and cold chain management

Expert Insight

The supply chain: key considerations for biological starting material for ATMPs production

The supply chain: key considerations for biological starting material for ATMPs production
Elisabet Aguilar
22 September 2020
Expert Insight
Read more
Utilization of risk-based approach to characterize starting material for autologous CAR-T manufacturing

Utilization of risk-based approach to characterize starting material for autologous CAR-T manufacturing
Jean Stanton
8 September 2020
Expert Insight
Read more

Innovator Insight

Biopreservation and cold chain biologistics risk points in the cell and gene therapy workflow

Biopreservation and cold chain biologistics risk points in the cell and gene therapy workflow
Todd CJ Berard ,
Aby J Mathew
3 November 2020
Innovator Insight
Read more

Interview

How will COVID-19 impact the cord blood banking sector?

How will COVID-19 impact the cord blood banking sector?
Wouter Van’t Hof
5 June 2020
Interview
Read more

Report

Regulatory Insights September 2020

Perspective

Advanced therapy regulation in the UK: what might the future hold post-Brexit?

Advanced therapy regulation in the UK: what might the future hold post-Brexit?
Patrick Ginty
18 September 2020
Perspective
Read more
Regulatory perspective on ATMPs: device combinations

Regulatory perspective on ATMPs: device combinations
Ilona Reischl,
Stefan Strasser
13 August 2020
Perspective
Read more

Interview

EMA CAT perspective: the European Union regulatory landscape for ATMPs

EMA CAT perspective: the European Union regulatory landscape for ATMPs
Martina Schüssler-Lenz
22 September 2020
Interview
Read more

Other articles

Expert Insight

Using serum-free media to streamline and optimize CAR T-cell manufacturing workflows

Using serum-free media to streamline and optimize CAR T-cell manufacturing workflows
Chengkang (CK) Zhang,
Amber Jones
10 September 2020
Expert Insight
Read more

Webinars

Scalable and efficient AAV production process with new Fibro chromatography technology

Scalable and efficient AAV production process with new Fibro chromatography technology
Laura Adamson-Small
Laura Adamson-Small, Upstream & Analytical Development Lead, AAV Process Development at UCB Pharma
Mats Lundgren
Mats Lundgren, Customer Applications Director, Life Sciences, Cytiva
Peter Guterstam
Peter Guterstam, Product Manager, Next Generation Resins & Technologies, Cytiva
30 July 2020
Webinar
Watch now
Size matters: ensuring donor pool sustainability and cell therapy supply chain success when scaling up and out

Size matters: ensuring donor pool sustainability and cell therapy supply chain success when scaling up and out
Chris Learn
Chris Learn, Senior Director - Therapeutic Strategy Lead, Cell & Gene Therapy at IQVIA
Amit Agarwal
Amit Agarwal, Managing Director at Deloitte Consulting
Raymond Hornung
Raymond Hornung, Senior Manager, Logistics at Be The Match BioTherapies
6 August 2020
Webinar
Watch now
Realizing flexible automation – Closing gaps to meet industry needs

Realizing flexible automation – Closing gaps to meet industry needs
Knut Niss
Knut Niss, CTO at Mustang Bio, Inc.
Steven Thompson
Steven Thompson, Director, Sales & Product Management at Sexton Biotechnologies
Mark Lowdell
Mark Lowdell, Professor of Cell & Tissue Therapy at Royal Free London NHS Foundation Trust
12 August 2020
Webinar
Watch now
Get your assay in gear – removing analytical bottlenecks on the path to clinical readiness

Get your assay in gear – removing analytical bottlenecks on the path to clinical readiness
Ian Gaudet
Ian Gaudet, Senior Director of Process Sciences at Miltenyi Biotec
8 September 2020
Webinar
Watch now
Optimizing antibody discovery strategy for clinical success of next-gen immuno-oncology therapeutics

Optimizing antibody discovery strategy for clinical success of next-gen immuno-oncology therapeutics
Patrick Ott
Patrick Ott, Clinical Director at Harvard Medical School
Ilse Roodink
Ilse Roodink, Scientific Director at ImmunoPrecise Antibodies
Nina Senutovitch Ph.D.
Nina Senutovitch Ph.D., Senior Scientist, Product Development, Cell Imaging, Sartorius
23 September 2020
Webinar
Watch now
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
Behzad Mahdavi, Vice President, Strategic Innovation & Alliances at Lonza Pharma & Biotech
Senthil Ramaswamy
Senthil Ramaswamy, Director
24 September 2020
Webinar
Watch now
The multi-modal manufacturing movement - you don't need to know the future to be ready for it

The multi-modal manufacturing movement - you don't need to know the future to be ready for it
Peter Walters
Peter Walters, ATMP Conceptual Designer at CRB
Noel Maestre
Noel Maestre, Director, ATMP at CRB
30 September 2020
Webinar
Watch now