Omega-3 manufacturers rise to their challenge

Excellent quality and multiple separation technologies are the key to success for omega-3 manufacturers, says Dr Peter Lembke

With 89,060 tonnes sold globally in 2013, and worth US$1.76 billion, the global consumption of omega-3 fatty acids, in particular EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) concentrates is still a very fast growing market. The strongly expanding omega-3-based pharma segment (including Lovaza, Omacor, Vascepa, Epadel and Epanova) and new-found consumer awareness is starting to focus more on higher concentrated omega-3 oils.

During the past few years a clear shift can be observed from the standard ‘18/12 fish oils’ (the first number refers to 18% EPA and the second to 12% DHA) towards higher concentrated and thus more efficient EPA and/or DHA concentrates. Only a couple of years ago the first products containing 33/22 oils were introduced to the market, quickly substituting a significant portion of the standard fish oils. Then higher concentrated oils such as 40/10, 10/40 and 10/50 entered the market. Recently, even higher concentrated EPA and/or DHA oils of up to well over 90% purity are used with growing popularity in the supplement and pharma field.

It is very likely that in a couple of years these highly concentrated omega-3 oils will dominate the global market due to the fact that they have a number of advantages for the consumer. Higher concentration means higher efficacy and improved health benefits. Smaller and easier to swallow capsules can contain the same amount of omega-3 as the former large ‘horse pills’. Highly concentrated EPA or DHA products can be targeted at particular health issues and for improved prevention and therapeutic effects.

The omega-3 manufacturing industry has to adjust to this trend. Simple molecular- or short pass distillation technology, which was useful in the past to produce the medium concentrated 33/22 to 10/50 oils, has reached its limits. Today and in the future, the requirements for a successful omega-3 manufacturer are far more challenging. With increasing concentration and purity, the manufacturing conditions shift from food/supplement quality requirements into the much more stringent pharma GMP regulations. 

Additionally, simple distillation units are no longer sufficient. Today a variety of separation technologies must be implemented by the manufacturer, including (but not limited to) various distillation technologies, urea fractionation, liquid and/or supercritical fluid chromatography, selective extraction technology and enzymatic transformation. Each technology has its own unique separation selectivity. A combination of these different separation selectivity factors coupled with a stringent quality assurance system is the key to future success in this increasingly competitive industry.

A good example of this strategy can be seen at KD-Pharma Bexbach, a cGMP-certified German omega-3 manufacturer. The company not only developed two supercritical fluid technologies – supercritical fluid chromatography (SFC) and supercritical fluid extraction (SFE) – for the production of EPA and/or DHA concentrates, it also has a repertoire of other technologies that include distillation and urea fractionation. As a result, the highest separation selectivity factors can be achieved via intelligent combinations of the abovementioned techniques. Clients may also choose unique EPA DHA ratios or products manufactured only using the company’s gentle and proprietary SFC technology.

Specialising in one omega-3 manufacturing technology was sufficient to be successful in the past, but a now maturing market will push manufacturers for further technological sophistication and differentiation in the future.

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Dr Peter Lembke is with KD-Pharma in Bexbach, Germany.

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