Hospital services company Leiters said on Wednesday that it will supply the repackaged Avastin in accordance with the Food and Drug Administration's 2018 final guidance for the repackaging of biologics, including its mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application.

The company said that the US FDA's 2018 final guidance requires 503B outsourcing facilities to repackage in accordance with cGMP and perform specific stability indicating tests to establish the beyond use date (BUD) of repackaged biological products, as well as conduct specific batch release testing.

Under the US FDA' the stability tests must be conducted by outsourcers to assure consistency with the approved labelling and must include appearance, colour and clarity, visible particulates, pH, sub-visible particles, protein content, impurities, potency and sterility.

According to the company, it has launched an extensive development process to meet the elevated requirements governing the repackaging of Avastin in response to 2018 US FDA guidance.

Bevacizumab, sold under the trade name Avastin, is a medication used to treat a number of types of cancers and a specific eye disease.