NIBSC - Collaborative studies

Below is a list of upcoming collaborative studies for which we welcome expressions of interest to participate. If you are interested in participating in any of these studies, then please e-mail the appropriate contact listed below.

Please note that an expression of interest is not a guarantee that you will be invited to participate. Where the number of interested laboratories exceeds the number of required laboratories, selections may need to be made to ensure that the study has a good balance across different analytical methods (where scientifically relevant for the study) and appropriate representation of participants from different sectors and geographic regions.

Therapeutics

Standard	Measurement	Expected launch date for study	MHRA-NIBSC contact (to express interest in participating)
New WHO standard for the characterisation of Fc domain interactions in biotherapeutics	Panel of reagents as benchmark in assays for Fc-domain binding to Fc Receptors and Complement	Q1 2027	Sandra.prior@mhra.gov.uk
Replacement WHO standard for interleukin-2	Interleukin-2 bioactivity	Q2 2027	ImmBioSurvey@mhra.gov.uk
Replacement WHO standard for Interleukin-1β	Interleukin-1β bioactivity	Q4 2027	ImmBioSurvey@mhra.gov.uk
Replacement WHO standard for Endotoxin	Bacterial Endotoxin Test (LAL and recombinant reagents), Monocyte Activation Test	Q3 – Q4 2027	ImmBioSurvey@mhra.gov.uk
Replacement WHO standard for Low Moleculer Weight Heparin for Molecular Weight Calibration	Weight Average Molecular Weight and molecular weight proportions	Q3 – Q4 2027	John.hogwood@mhra.gov.uk

Infectious Disease – Vaccines/Serology/Diagnostics

Standard	Measurement	Expected launch date for study	MHRA-NIBSC contact (to express interest in participating)
Replacement WHO standard for Diphtheria Vaccine (adsorbed)	Potency of diphtheria vaccine (challenge / serology models)	Q3-Q4 2027	Bacvac@mhra.gov.uk
New WHO standards for antibodies to human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58	Anti-human papillomavirus antibody potency in human serum/plasma	Q1-Q2 2027	Virvac@mhra.gov.uk
Replacement WHO standard for Anti Rubella Immunoglobulin	Anti-rubella antibody levels in human serum/plasma	Q1 2027	Virvac@mhra.gov.uk
Replacement WHO standard for anti-hepatitis B surface antigen (anti-HBs) immunoglobulin	Anti-hepatitis B antibody levels in human serum/plasma	Q3 2027	Virvac@mhra.gov.uk
New WHO standard for Haemophilus influenzae b antibodies (human serum)	Anti-Hib antibody levels in human serum/plasma	Q1-Q2 2027	Bacvac@mhra.gov.uk
New WHO standard for antibodies to Oropouche virus	Anti-OROV antibodies in human serum/plasma	Q3-Q4 2027	Yann.LeDuff@mhra.gov.uk
New WHO standard for antibodies to Hantavirus	Anti-hantavirus antibodies in human plasma/serum	Q4 2027/ Q1- 2028	Yann.LeDuff@mhra.gov.uk
New WHO standard for Aspergillus fumigatus DNA for NAT (pilot phase)	Aspergillus fumigatus DNA	01/2027	diagidm@mhra.gov.uk
New WHO standard for Aspergillus fumigatus galactomannan(pilot phase)	Aspergillus fumigatus galactomannan	01/2027	diagidm@mhra.gov.uk
Replacement WHO standard for Human Cytomegalovirus DNA for NAT	Human Cytomegalovirus DNA	Q3 – Q4 2027	diagidm@mhra.gov.uk
New WHO standard for Mpox DNA for NAT	Mpox DNA	Q2-Q3 2027	diagidm@mhra.gov.uk