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Quil-A® Quality

Quality Basics:

Brenntag Biosector is GMP-certified by the Danish Medicines Agency as a producer of medicinal products.  Consequently, it can follow all material flow from raw-material over final product to end-user. This further means that all critical production steps are subject to validation, that all suppliers are audited and that raw material and final products are tested for compliance with the relevant monographs (USP, EP where applicable).

Incoming control:

All the raw materials, including the water (Aqua pur.) are subject to a thorough incoming control to verify compliance with the relevant monographs and GMP.

Testing at raw material level:

Before Brenntag Biosector can approve a batch of cortex-derived raw material for use in the production of Quil-A® a comprehensive in vitro as well as in vivo testing schedule is undertaken.  This involves the preparation of a test vaccine to be injected into a rodent model, with subsequent bleedings and test for ADJUVANT activity/antibody titres. It also involves a test for the ability to form ISCOMs. Only batches of raw material that fulfill these criteria will be taken into production by Brenntag Biosector.

Hygiene and storage:

Lyophilized Quil-A® can be stored frozen or at room temperature up to 30 degrees Celcius. But it is essential that it is not subjected to humidity, as the lyophilized product is low in CFU, but not sterile.

Securing a good hygienic standard during storage is essential for all the products.

Brenntag Biosector has carefully chosen transporters which can bring the products from the warehouse to the client's warehouse in a nice and clean condition.

Measures must be taken to secure good hygiene during storage. Under no circumstances should the products be stored outdoors, even for a limited period of time.

Provided it is kept dry, the product can be stored for up to two years at room temperature or up to five years if stored in the freezer.