Infliximab monograph adopted by European Pharmacopoeia Commission

By Gareth Macdonald contact

- Last updated on GMT

Gettyimages/ultramarine5
Gettyimages/ultramarine5
European Pharmacopoeia Commission has adopted the first monograph for a monoclonal antibody and is poised to add it to the European Pharmacopoeia.

The Commission adopted the “Infliximab concentrated solution” monograph last month​ according to the European Directorate for the Quality of Medicines & HealthCare (EDQM), which said it marked the end of several years of development. 

The Ph. Eur. Commission embarked upon the setting of public standards for therapeutic monoclonal antibodies (mAbs) in 2014 with a pilot phase and following extensive consultation with its stakeholders​.”

The EDQM added that the collaborative approach was required to give the monograph the flexibility needed to accommodate the process-dependent heterogeneity associated with mAbs and their production.

 “The approach used to set the monograph specifications is oriented towards promoting flexibility, notably in addressing process-dependent product heterogeneity.

Significantly, criteria for verifying the performance of analytical methods are included, which will support robust methodologies, while the provision of examples of suitable procedures for complex assays enables the use of alternative methods​,” the directorate said.

The newly adopted infliximab monograph will be included in Pharmacopoeia Supplement 9.6 and will become effective in January 2019.

Related news

Show more

Related products

show more

An Intense Focus on Perfusion

An Intense Focus on Perfusion

MilliporeSigma | 09-Oct-2017 | Technical / White Paper

Continuous manufacturing technologies are seeing increased industry uptake, particularly perfusion systems and, increasingly, intensified perfusion. Perfusion...

A Trusted Resin Provider For Over 35 Years

A Trusted Resin Provider For Over 35 Years

Purolite Life Sciences | 18-Sep-2017

Watch our video above to learn more about the history of Purolite Life Sciences.To discuss how we can assist your journey to process excellence, please...

The Next Stage – Eppendorfs new Mastercycler X50

The Next Stage – Eppendorfs new Mastercycler X50

Eppendorf for Bioprocess – Solutions that grow with you | 05-Sep-2017 | Application Note

The Mastercycler X50 is Eppendorf's new PCR cycler with lots of new benefits. Not only can you heat with 10°C/s, you can also optimize two different...

Related suppliers