Biological Standards and Assays Working Group

Biological Standards and Assays and its Importance

Biological standardization plays a major role in advancing vaccines. International standards enable the harmonisation and standardisation of assay data which in turn allows evaluation of product development as well as on-going quality control throughout a product’s life cycle.

Proper standards and common assays allow comparison between different vaccines, on different platforms at various stages of the product’s development, as well as enabling differing groups to investigate products and provide comparable data.

With common, available standards different vaccine candidates can be compared without the need for simultaneous head-to-head trials and through the establishment of validated assays, (or panels used for bridging of used laboratory standards to international standards) T-cell and antibody responses can be measured in a comparable way that allows for understanding of the correlates of protection and informed selection of vaccine candidates.

This work allows for improved portfolios of products and more effective use of resources. Meanwhile standards also allow for common interpretation of data from various laboratories; this improves understanding of disease burden, natural history of the disease and measuring immunological responses, allowing for more informed models and better selection of trial designs.

CEPIs work to date

CEPI has begun work in the area of Biological Standards and Assays through the formation of a consultative working group of technical experts. The group was called upon to propose and develop a strategy for this work stream, and will continue to guide and provide technical expertise and input throughout. Supporting this group will be three pathogen specific Task Forces, one each for; MERS-CoV, Nipah and Lassa.

 

First Workshop for the Working Group – 12th December 2017

The first meeting enabled the group to address the needs for the three CEPI priority pathogens, to identify a strategy to map current materials, work and interests. The group was able to raise the needs in terms of expertise and areas of work (proposing the development of specific Task Forces, their composition, membership and the scope of their work). The meeting allowed for identification of knowledge gaps and of limitations or likely hurdles in the implementation stages.

The meeting also allowed for the discussion of existing standards and strategies for activities that are ongoing during this development stage (namely interim guidance on animal models, interim standards and guidance on laboratory standards). Lessons learned from Ebola and from work on the three pathogens, to date, were shared and helped guide the strategy development. Below you can find the Workshop Outcomes as Notes and pdf of the presentations along with all presentations except two, which had to be removed due to confidential information.

Meeting minutes

PDF FORMAT - 983KB

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Presentations from the meeting

The following presentations from the meeting can be downloaded:

  1. Introduction of the Working Group and Aims of the Workshop - Johan Holst
  2. Basics of Biological Standards and Standardization - Elwyn Griffiths

  3. Expectations of the WG on Standards and Assays from CEPI’s Vaccine Development Program and from a Clinical Perspective - Melanie Saville

  4. Regulatory Requirements to Pre-clinical Data - Robin Levis

  5. FDA Animal Rule applied on MERS-CoV Vaccine Development - Carol Sabourin

  6. Lessons from Ebola - Larry Wolfraim

  7. Clinical Studies for Convalescent Sera - Tommy Rampling

  8. Animal Models for Lassa, Nipah and MERS-CoV - Margaret Louise Pitt

  9. Lassa: Available Assays and Reference Materials - Igor S. Lukashevich

  10. Nipah: Available Assays and Reference Materials - Christina Spiropoulou

  11. Product Profiles for Biological Standards within the Scope of CEPI’s Working Group - Johan Holst

ZIP FORMAT - 14KB

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Lassa Task Force

The first Task Force under the Biological Standards and Assays working group was formed on 20th April 2018. The Task Force will analyse needs and make suggestions on actions and funding. It is meant to be more “hands on” and closer to the actual work on development and evaluation of vaccines against Lassa fever.