This week, the Process Development Forum talks to Dr. Neil Goss, an international consultant in biotechnology and plasma fractionation, past director of Research and Development at CSL BioPlasma, Australia, and co-author of Production of Plasma Proteins for Therapeutic Use.
Plasma fractionation is sometimes considered as a conservative industry and less open to changes. Do you agree?
The plasma fractionation industry has often been regarded as a curiosity or an anachronism of the much larger pharmaceutical and biopharmaceutical industries, but this perception disguises the effect that these essential, lifesaving plasma products have on the healthcare and well-being of a vast number of communities around the world. It is true that the fundamental technology employed by essentially all plasma fractionators is based on methodologies developed by Edwin Cohn and colleagues in the late 1930s and early 1940s, but since that time, substantial improvements in the manufacturing processes have resulted in higher yields, a more diversified product range, and, most importantly, a significantly enhanced viral safety profile. The result of these activities has created a dynamic and robust industry that currently generates in excess of USD $21 billion per year.
What is the status of plasma fractionators, especially in Asia?
Over the last two decades, there has been a major consolidation of the industry players, with several national fractionators becoming either commercial entities or ceasing production. The consequence of this consolidation is that the industry is now dominated by a handful of players including CSL, Grifols, Takeda (Shire), and Octapharma. The remaining smaller fractionators have been the subject of significant take-over speculation, with BPL in the UK, and more recently Biotest in Germany, being acquired by the privately held Chinese company Creat. According to John Perkins, past CEO of BPL Holdings, the stated intention of Creat is to become the third largest plasma fractionator in the world. In addition to this activity, several other Chinese fractionators are currently investing heavily into new, large facilities, all of which utilize modern chromatographic processes to produce plasma products of very high quality and safety. It is not inconceivable that over the next decade China will become a major player in the international plasma products space.
Elsewhere in Asia, the Thailand Red Cross, in conjunction with the Korean Green Cross Corporation, has completed construction of a 200-ton facility in Chouburi Province. In India, Reliance Life Sciences manufactures a range of plasma products for the subcontinent and Sri Lanka. Meanwhile, Intas and Hemarus have smaller fractionation capacities. In Korea, three companies are fractionating plasma: the Korean Green Cross, which operates two fractionation plants, the Korean Red Cross, and SK Plasma, which recently opened a new facility in Andong. In Japan, three companies are fractionating plasma: the Japan Blood Products Organization, the Chemo-Sero Therapeutic Research Institute (Kaketsuken), and Takeda, which recently acquired the Shire plasma fractionation business.
There remains, however, continued interest in the establishment of new modern plasma fractionation facilities in other countries in the region. With the burgeoning Asian economies, this activity is likely to continue.
You are part of the organization committee for the 3rd BioProcessing Asia Conference, which will take place November 12-15, 2018 on Langkawi, Malaysia, and with a session dedicated to plasma fractionation. What are some specific topics you think will be covered, and what are you looking forward to during that conference and session?
The major purpose in establishing the BioProcessing Asia Conference Series was to create a non-commercial forum for the exchange of concepts, ideas, and information relating to the manufacture of biological products in the Asian region. The inclusion of a specific plasma fractionation session in the Series highlights the importance of this topic within the broader biopharmaceutical field and helps focus attention on the critical areas of quality and safety, which is so important in modern biological manufacture. It is these new quality and safety initiatives, coupled with novel manufacturing approaches, that I look forward to hearing about in the BPA 2018 Conference in Langkawi in November.