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Published: 18 August 2019

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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 Product development, 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)

• Product development (Jul-11)
• Importance of Characterisation (Aug-08) 
• Comparability  (Oct-11)
• Regulatory Considerations for Technology Transfer  (Feb-12)
• Use of reference materials  (Nov-11)
• Agency Advice (EU/US) (Nov-11)

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

• ICH guidelines (Jan-19) Minor update to include new guidelines
• EMA guidelines (Jan-19) MAJOR UPDATE, now includes gene therapy
• FDA guidelines (Jan-19) MAJOR UPDATE, now includes gene therapy
• Guidelines related to Reference Materials  (Mar-15)
• Comparability guidelines  (Oct-11)

Pharmacopoeial chapters with relevance to cell-based medicinal products:

• PhEur (Aug-11)
• USP (Aug-11)

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

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

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

NEW!!  ATMP Standards mapping exercise

With so many organisations writing standards for cell, gene and tissue therapies its easy to lose track of them all.  This is an initial draft map (Dec 2020), please feel free to send details of any standards not yet included.

Note: for pharmacopeia’s, only texts specific to ATMP are included.

NEW in Beta!! Elements of the CoA when selecting materials.

This decision tree is designed to aid evaluation of the certificate of analysis (CoA) of a material to ensure the range of methods included are appropriate.

This is a beta version, so please do provide feedback at info at advbiols.com

Coming soon: decision tree for identifying and mitigating risks associated with raw materials.

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). 

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Written by Javi

Category: Uncategorised

Published: 18 August 2019

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2010

December

• "Sourcing and Quality of Staring and Raw Materials" 
• Panel discussion
• Christopher A, Bravery, PhD.
• Informa Life Sciences's Inaugural: Cell Theraphy Manufacturing: Steam Cells and Immunotherapies.
• London, U.K.

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

• "Should autologous cell therapy companies have the right to refuse treatment to patients?"  
• Christopher A, Bravery, PhD.
• London Regenerative Medicine Network.
• London, U.K.

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Written by Javi

Category: Uncategorised

Published: 18 August 2019

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2009

December

•  "Regulation of NanoTechnology: Do the current rules fit?" 
• Christopher A, Bravery, PhD.
• Nanotechnology KTN: Nano-structure Materials in Tissue Engineering(NanoMITE).
• London, U.K.

November 

•  "Overview of the regulation of advanced therapy medicinal products (ATMP) in the EU"  
• Christopher A, Bravery, PhD.
• RegeNer8 Annual Meeting. Translation of regenerative medicine into early phase trials and beyond.
• York, United Kingdom.

October

• "What are ATMP's: Why do they require special scientific and regulatory attention?" 
• Christopher A, Bravery, PhD.
• Figon Dutch Medicine Days, Oct 12-14 2009. Developing Ground breaking New Treatments for Gene and Cell Therapy and Tissue Engineering.
• Lunteren, the Netherlands.

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Written by Javi

Category: Uncategorised

Published: 18 August 2019

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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

•  "Regulatory requirements for early stage clinical trials with cell-based medicinal products" 
• Christopher A, Bravery, PhD. 
• World Conference on Regenerative Medicine
• Leipzig, Germany
• Speaker

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

October

• "Regulatory issues to watch for during tech transfer between sites"  
• Christopher A, Bravery, PhD.
• IBC's Inaugural Cell Therapy Bioprocessing
• Virginia, United States.
• Speaker

• "Regulating Cell Therapy: An Ex-regulators perspective"  
• Christopher A, Bravery, PhD.
• Seminar, ESRC Innogen Centre
• Edinburgh, Scotland
• Speaker

June

• "A Review of the Global Clinical and Commercial Activity in Cell and Gene Therapies"  
• Christopher A, Bravery, PhD.
• PDA 2011 Europe Workshop on Advanced Therapy Medicinal Products.
• Helsinki, Finland
• Speaker

May

• "The EU Risk-Based Approach: What Does it Mean?"  
• Christopher A, Bravery, PhD.
• International Society for Cellular Therapy: ICT 2011 Annual Meeting.
• Rotterdam, The Netherlands.

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

• http://www.celltherapysociety.org/index.php/meetings-events/webinars/isct-webinars#march16 
• Christopher A, Bravery, PhD.
• Webinal: Potency testing.
• London, United Kingdom.

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

• "Common Regulatory Issues for Stem Cell Products" 
• Christopher A, Bravery, PhD.
• UKNSCN Fourth Annual Science Meeting.
• York, United Kingdom.

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