Media Manufacturing & Quality Control

The Bovine Embryo Assay (BEA) test is the most important!

There are huge differences in reproductive physiology between the mouse and cow, therefore a MEA test is not sufficient QC for a bovine medium. 

The oocyte maturation is more complex in cows; fertilization and capacitation are species specific and a MEA test mostly assesses blastocyst development from either one-cell or two-cell stage embryos. Should a batch variation occur it will not be detected in a MEA test, where release parameter is > 80 % blastocyst rate. In the BEA test, however, a difference in medium quality can be detected even though the medium passes the MEA test. For instance, 35 % vs 55 % blastocyst rates indicate two media are different, however both media will have passed the MEA.

ISO9001 and ISO13485 certified production site

ISO standards are internationally agreed by experts and when a factory is certified it ensures state-of-the-art manufacturing in a controlled environment and is your assurance of quality.

ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size.

ISO 13485, also known as the medical device regulatory system, is a quality system for the medical device industry. It also means that the factory is audited through Medical Device Single Audit Program.

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of the  manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

A MDSAP audit assures compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.

Plastic vs Glass bottles

Only in glass bottles can you maintain stability of the active compounds in the media for up to 18-24 months. Plastic will decrease quality of media over time and even contribute to toxicity and will always have a limited shelf-life. The Entire batch must be manufactured in one day. That means that no stock solutions should be stored for a longer period of time and that the entire batch should be manufactured and bottled within the same day and not stored overnight.

Batch Certificate

Every single batch should always come with a batch certificate stating that sterility, fungal and endotoxin tests have been performed and passed quality control specifications. For some products pH will be measured, but it doesn’t make sense to have a set pH value release criterion for pH, if the buffer is CO2 calibrated with bicarbonate.

The BEA test is essential for knowing the quality of your medium