2019

December

  • Cell & Gene therapy manufacturing congress
    • Christopher Bravery
    • Amsterdam, Netherlands
    • Panellist, trainer & chair

 

November 

  • 2019 PharmSci 360
    • What’s Different about Potency Assays for Cell and Gene Therapy?
    • Texas, USA
    • Speaker

 

August 

 

June

  • ATMP, are we there yet? 
    • Advanced Therapy Medicinal Products - From Promise to Cure
    • Christopher Bravery
    • Vilnius, Lithuania

 

March

  • 2019 Cell Therapy CMC and Manufacturing Europe
    • Christopher Bravery
    • Boston, MA
    • Speaker, chair & workshop

 

February

  • Cell therapy Manufacturing Asia
    • Christopher Bravery
    • Tokyo, Japan
    • Pre & Post conference workshops

Product Development

Most cell and gene therapy products are regulated as medicinal products in the EU and the US; as such their development must result in data that confirm quality, safety and efficacy.  
 
One of the key objectives of
 , aside from demonstration of clinical efficacy, is to fully understand the characteristics of the product and the process used to make it. Characterisation is central to product development, this figure provides an overview of the scope of characterisation activities and how they interrelate.

Effective development processes provide all the tools necessary to implement changes, and these tools are a result of thorough characterisation.  Implementation of changes to the manufacture of medicinal products requires that the product before and after the change is comparable.  Comparability is a central concept in the regulation of medicinal products; this tool provides an overview of the various parameters that might be required for a comparability exercise. 

 

Regulatory Tools (last update)

 

Regulatory Guidance (last update)

There are a number of specific guidelines covering the development of ATMP's, however, many more general biological/biotech guidance is also indirectly relevant since they provide the general principle described in ICH documents are harmonised across ICH member countries

Pharmacopoeial chapters with relevance to cell-based medicinal products:

Note: These figures do not include hyperlinks since the content requires subscription.

 

UPDATE: The Common Technical Document (CTD) (Version 2.1 December 2019)

Now with increased detail including excerpts from ICH guidelines and authors comments and suggestions 

 

Instructions: Many of these tools are interactive and can be expanded or collapsed by clicking on the (+).  Alternatively you can expand or collapse levels by right clicking on the diagram and selecting the required level.  

Links to external documents are included and indicated by the following symbol Simply click to open the document in a new tab.

Some tools contain notes, hover or click on note symbol   to see note.

Feedback

We value your feedback; should you have comments or suggestions for inclusions and amendments please let us know. Contact: info at advbiols.com

 

Acknowledgements

These tools were developed with the support of a grant from the Technology Strategy Board as part of the VALUE consortium (Regenerative Medicine Value Systems: Navigating the Uncertainties) lead by Biolatris Ltd (http://www.biolatris.com). 

2010

 

December

 

July

  • HealthTech and Medicines KTN Regenerative Medicines. US Mission
    • Christopher A, Bravery, PhD.
    • Knowledge Transfer Network.
    • Boston, MA, United States.

 

June

  • Panel discussion.
    • Christopher A, Bravery, PhD.
    • ISSCR/CIR/ISCT Workshop: Stem Cell Therapies in Clinical Trials- Best practices and the need of Harmonization.
    • San Francisco, California, United States.

 

April

2009

December

 

November 

 

October

2011

 

December

  • "Reference Standards: Regulatory requirements" 
    • Christopher A, Bravery, PhD. 
    • Informa Life Sciences 2nd Annual: Cell Therapy Manufacturing: Stem Cells and Immunotherapies.  
    • Chair, speaker, panel discussion, workshop.
    • Brussels, Belgium

 

November

  • Joint DIA/MHRA Workshop on Advanced Therapy Medicinal Products
    • Christopher A, Bravery, PhD. 
    • London, UK
    • Chair, panel discussion

 

October

 

June

 

May

 

April

  • "What's happened since Regulation 1394/2007?"  
    • Christopher A, Bravery, PhD.
    • Regenerative Medicine in Europe (REMEDIE): Bringing Regenerative Medicine to the Clinic: Trials and Tribulations in Europe and Beyond.
    • Bilbao, Vizcaya, Spain.

 

March

  • Seminar
    • Christopher A, Bravery, PhD.
    • EUCRAF: Particulars of authorisation of biopharmaceuticals.
    • Freiburg, Germany.

 

January 

  • Workshop on progress towwards Clinical Trials using stem cells for ALS/MND
    • Christopher A, Bravery, PhD.
    • International Consortium of Stem Cell Networks (ICSCN).
    • New York, United States