Infliximab monograph adopted by European Pharmacopoeia Commission

By Gareth Macdonald contact

- Last updated on GMT

Gettyimages/ultramarine5
Gettyimages/ultramarine5

Related tags: Monoclonal antibodies, European pharmacopoeia, European directorate for the quality of medicines

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

Partner with Experts in Precision Medicine

Partner with Experts in Precision Medicine

CellCarta | 17-Jan-2022 | Product Brochure

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

High quality excipients and formulation support

High quality excipients and formulation support

Roquette Pharma Solutions | 09-Nov-2021 | Product Brochure

As the world grapples with the effects of ongoing health crises, the market is expanding quickly as developers shift their focus to proactive therapeutics....

Protect your bulk filtration and dispense step

Protect your bulk filtration and dispense step

Parker Bioscience Filtration | 20-Jan-2020 | Data Sheet

Does your process need greater protection when the value of your product is at its highest?

At the bulk filtration and container fill stage,...

Related suppliers

Follow us

Products

View more

Webinars