CELL AND GENE THERAPY INSIGHTS

Raw and starting materials

March 2021
Raw and starting materials
Download PDF

Foreword

Raw and starting materials

Raw and starting materials

Elizabeth Read
26 March 2021
Read

Editorial

Considerations for controlling the variability of raw biological materials in the manufacturing of autologous patient-specific therapies

Considerations for controlling the variability of raw biological materials in the manufacturing of autologous patient-specific therapies

Sanjin Zvonic
16 March 2021
Read

Expert Insight

The case for the use of pooled donors in the manufacture of allogeneic cell therapies

The case for the use of pooled donors in the manufacture of allogeneic cell therapies

Benjamin Weil, Mark Lowdell
24 March 2021
Read
Upholding raw material suppliers to higher quality standards to better support cell and gene therapy manufacturers

Upholding raw material suppliers to higher quality standards to better support cell and gene therapy manufacturers

Monica C. Nelson, PhD
5 March 2021
Read

Innovator Insight

Developing an understanding of the analytical landscape for testing complex biological raw materials in advanced therapy medicinal products: a CRO perspective

Developing an understanding of the analytical landscape for testing complex biological raw materials in advanced therapy medicinal products: a CRO perspective

Alistair Michel, David Neville
25 March 2021
Read
Fitting product to process: raw materials customization for cell therapy manufacturing success

Fitting product to process: raw materials customization for cell therapy manufacturing success

L Belcastro, M Brabec, L Clarke et al.
22 March 2021
Read

Commentary

Master ATMP processes by controlling raw and starting material

Master ATMP processes by controlling raw and starting material

Anne-Sophie Lebrun, Carmen Brenner
24 March 2021
Read
Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Gary C du Moulin, PhD, MPH, RAC
18 March 2021
Read

Interview

Expect the unexpected: maintaining and optimizing a cell collection network during COVID-19

Expect the unexpected: maintaining and optimizing a cell collection network during COVID-19

Amy Hines
26 March 2021
Read
Managing raw and starting materials for viral vector manufacture: managing risk and staying flexible

Managing raw and starting materials for viral vector manufacture: managing risk and staying flexible

E Hacherl, C Klem, M Galbraith et al.
26 March 2021
Read
Emerging trends in control and regulation of immunotherapy cellular starting materials

Emerging trends in control and regulation of immunotherapy cellular starting materials

Nate Manley
19 March 2021
Read
Sourcing and procurement best practices in the face of uncertainty

Sourcing and procurement best practices in the face of uncertainty

Richard Stout
18 March 2021
Read

Regulatory Insight

The importance of starting materials: quality and regulatory considerations for cell-based therapies

The importance of starting materials: quality and regulatory considerations for cell-based therapies

B Bonamassa, P Gasparini, G Pompilio et al.
25 March 2021
Read

Webinars

Raw materials of biological origin: navigating regulatory requirements for cell therapies

Raw materials of biological origin: navigating regulatory requirements for cell therapies

Marlin Frechette, Dominic Clarke
13 January 2021
Watch
Focusing on donor characteristics and efficient selection to improve allogeneic cell therapy outcomes

Focusing on donor characteristics and efficient selection to improve allogeneic cell therapy outcomes

M Maiers MS, B Aftab PhD, D Gibson et al.
21 January 2021
Watch
Fitting product to process: raw materials customization for cell therapy manufacturing success

Fitting product to process: raw materials customization for cell therapy manufacturing success

J Paul Tomtishen III, L Clarke PhD, L Belcastro PhD et al.
11 February 2021
Watch
Key considerations for hMSC product and process development through clinical cGMP manufacturing

Key considerations for hMSC product and process development through clinical cGMP manufacturing

J Rowley, R Barcia, J Candiello et al.
28 April 2021
Watch