EMA Draft Guidance Adds Testing Requirements for Manufacturers of Bovine Serum

Posted 01 October 2012 | By Alexander Gaffney, RAC 

The European medicines Agency (EMA) has released a new draft guideline for manufacturers who use bovine serum when producing biologics for human consumption, adding additional testing requirements to screen for bovine viral diarrhea virus (BVDV).

The 1 October draft guideline, Use of bovine serum in the manufacture of human biological medicinal products, specifically revises two sections of a 2003 guideline on the same topic: Sections 7.3.3 and 7.3.4, both of which pertain to testing requirements for BVDV.

The broader intent of the guideline is to reduce the risk of transmission of bovine spongiform encephalopathy (BSE), also known as mad cow disease, and BVDV, a cattle virus. Though EMA's guideline recommends sponsors use non-ruminant (cow)-based materials, it acknowledges that some materials, and in particular bovine serum, are essential to the manufacture of some biological culturing processes.

Controlling the quality of bovine serum used in biologics manufacturing, then, is of the utmost importance to stem the risk of transmitting BSE, BVDV and other "deleterious effects."

Traceability, Testing Key Requirements of Guideline

Serum-commonly foetal bovine serum (FBS)-should only be collected by trained personnel using specified methods. Strong oversight of an animal's supply chain should also be used to ensure they come from regional or national control programs meant to minimize the use of unsafe feeding or slaughter methods that can transmit BSE or BVDV.

This is particularly important when establishing a product's pedigree, explains EMA. "The traceability of serum from final container back to the abattoir of origin is of prime importance and a clear audit trail must be demonstrable including records of volumes at each stage. Traceability of serum from final container to farm of origin should be ensured for donor herds used to obtain Donor Bovine Serum."

A certificate for traceability purposes should show the catalogue number, batch number, country of origin of all source animals, final batch volume, data of manufacture, the product's shelf life, certification that a serum is bovine-only and information on the physico-chemical properties of the serum.

BVDV Testing

Though BSE testing has long been a requirement for manufacturing serum in the EU, EMA's new draft guideline also adds a requirement for BVDV testing as well.

Regulators note that the detection of the virus is difficult and its presence in a bovine serum, "Cannot completely be avoided." That being said, EMA explains that any contaminants found should be inactivated or removed before the serum is retested.

The final serum should be free from all viral, fungal, bacterial or mycoplasma contaminants.

Sponsors should also be wary of anti-BVDV antibodies, which can mask the presence of BVDV in a serum. The use of validated testing for all detection methods is required, added EMA.

Though the guideline applies specifically to serum obtained from bovine species, its principles are applicable to serum obtained from other species for similar purposes, such as horses.

Consultation on the document ends 31 December 2012.

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