ALBA BIOSCIENCE RECEIVES FDA CLEARANCE FOR MONOCLONAL BLOOD TYPING REAGENTS

Alba Bioscience will now be able to increase its position in the world’s largest market for blood typing diagnostic products, estimated to be worth over $300 million.

Alba Bioscience is a leading, technology-based business focused on the manufacture and sale of blood typing reagents and systems worldwide. Built up over 40 years, the Company has an excellent reputation for the supply of vital blood typing reagents and other products.

Alba Bioscience has recently increased its production capacity to address the anticipated increase in its sales to the US.

John Allan, CEO of Alba Bioscience said: “This achievement is the culmination of many years of hard work and marks a major milestone in the Company’s development. We are the only non-US company that has FDA clearance to supply reagents of this type. This will provide the springboard for the future growth of the Company.’’

Alba Bioscience will launch these new products at the prestigious American Association of Blood Banks meeting next month (October) in California, attended by over 3,000 transfusion and blood specialists from around the world.

Ian Carmichael, Quality & Regulatory Affairs Director at Alba Bioscience, highlighted the fact that: ‘’The FDA clearance process is extremely stringent and involves rigorous inspection of manufacturing facilities, processes and quality systems. Our premises have been audited and approved by the FDA and we aim to leverage this to progress business growth in other countries.”

Recently the Management Team of Alba Bioscience and Quotient BioResearch Limited completed a buy-out of the business from the NHS in Scotland. At that time they pledged to continue to build on past successes and further accelerate the development of key products to be offered to both hospitals and blood transfusion services in Scotland and worldwide.

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