Raw and starting materials

CELL AND GENE THERAPY INSIGHTS

March 2021

Raw and starting materials

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Foreword

Raw and starting materials

Raw and starting materials

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

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

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

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

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.

Commentary

Master ATMP processes by controlling raw and starting material

Master ATMP processes by controlling raw and starting material

Anne-Sophie Lebrun, Carmen Brenner

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

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

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.

Emerging trends in control and regulation of immunotherapy cellular starting materials

Emerging trends in control and regulation of immunotherapy cellular starting materials

Sourcing and procurement best practices in the face of uncertainty

Sourcing and procurement best practices in the face of uncertainty

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.

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

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

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

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.