Kim Tae-han, the CEO of South Korea’s Samsung Biologics, said Wednesday that he expects to take on contract manufacturing deals for Alzheimer’s disease treatments, and that the company will be ready when the opportunity arises.
Kim, speaking to investors at JP Morgan Healthcare Conference 2020 in San Francisco, said Biogen’s Alzheimer’s pipeline aducanumab has proven its efficacy through data. The only hurdle to US Food and Drug Administration (FDA) approval, Kim said, was the compliance issue – one of Biogen’s two phase III clinical trials had fewer people than initially pitched.
“So the pending question is if FDA will still recognise aducanumab’s efficacy. But even if aducanumab fails to gain FDA approval, there’s still going to be another molecule from another company. Eli Lilly and Roche are both also tackling the Alzheimer’s. And after that, there will come the Parkinson’s and Huntington’s treatments, won’t they?” Kim said.
There are 50 million Alzheimer’s patients worldwide. If 10 per cent of these patients sought the new treatment, considering that the annual dose per patient is 8g, the company estimates that 42 tonnes of the drug would have to be produced every year to meet demand.
Samsung Biologics, the biggest contract manufacturing organisation in terms of throughput capacity, can produce 20 tonnes at its third plant.
Currently, the first and the second plants are operating nearly at full capacity, while the third plant is 35 per cent utilised.
“Our goal last year was to achieve 50 per cent utilisation rate for plant 3 but the accounting issue hampered that. For 2020, we aspire to utilise 60 per cent of our plant 3,” said Samsung Biologics vice-president John Rim, taking the baton from CEO Kim in the presentation.
If Biogen’s Alzheimer’s CMO deal falls on Samsung Biologics, it would not only hit 100 per cent utilisation of its third plant, but would also require a fourth. And that’s where Samsung Biologics is ahead of its competitors.
Samsung Biologics already has a big slab of land secured next to its three plants in Songdo, Incheon. It can build a biologics plant that adheres to good manufacturing practices 40 per cent faster than most other companies in the same field.
Samsung Biologics’ first plant was ready in 25 months, the second plant in 29 months and the third and most innovative one in 35 months, the company said. Most firms take four to five years.
The company can build its plants at this rapid rate thanks to Samsung Group’s experience of having built some 1,700 plants, including over 20 semiconductor plants.
A semiconductor plant and a biologics plant share much in common, as both must be completely aseptic and transparently operated. A petrochemical plant has piping techniques akin to those of a biopharma facility.
At its first plant, Samsung Biologics has six 5,000-litre bioreactors capable of holding 30,000 litres total. At the second plant, it has 10 15,000-litre and four 1,000-litre bioreactors for a total capacity of 154,000 litres. At the third plant, there are 12 15,000-litre bioreactors with a total capacity of 180,000 litres.
The first plant is the industry standard, while the third houses much bigger bioreactors, equipped with N-1 perfusion technology so that cell lines grow 10 times faster than they otherwise would.
If Biogen’s aducanumab receives the green light from the FDA, Samsung Biologics is indeed a likely contract manufacturing organisation (CMO) partner. The ideal plan in that scenario would be to create a fourth plant that is a replica of the third.
Biogen and Samsung Biologics share facilities through a unique relationship, having opened a biotech joint venture called Samsung Bioepis. Not only do the two work together, but Samsung Biologics’ cutting-edge facility is available for immediate use.
The Korea Herald/ANN