The Uppsala headquartered company supplies products for the purification of large-scale lipids, used in mRNA vaccine development and production.
It claims that by enhancing production capacity of large-scale flash columns by 300%, it can support pharma companies and contract manufacturers’ scale up lipid production for COVID-19 vaccines. The bespoke production site is now operational in Cardiff.
“We were very pleased to be able to deliver this expansion in just over four months in order to meet the needs of present and potential new clients,” said Anders Wikström, EVP operations, Biotage.
The availability of raw materials for mRNA vaccine production has been a major bottleneck as the lipids that were needed for new lipid nanoparticle (LNP) formulations used in mRNA vaccines were not previously available on the scale needed to produce billions of doses of vaccine globally, said the Swedish firm.
The newly opened production facility will enable Biotage to meet the increase in demand for this vital market segment, without any disruption to existing clients already producing APIs, fine chemicals, natural products or in other markets.
The development proves that the company has “a keen ear to our customers’ needs” and that it has “built an organization capable of moving quickly to meet new demand in rapidly growing niche markets” within the pharmaceutical industry, said Tomas Blomquist, CEO, Biotage.
Biotage’s customer base spans a broad range of market segments including pharmaceutical, biotech, contract research and contract manufacturers as well as clinical, forensic and academic laboratories in addition to organizations focused on food safety, clean water and environmental sustainability. It employs around 485 people worldwide.
Meet demand for lipid technology
In May this year, we reported on how Germany’s Merck KGaA was rolling out new lipid technology in advance, with it launching a new synthetic cholesterol product that it said would boost capacity for its lipid delivery tools by 50 times.
Andrew Bulpin, head of process solutions, Merck, noted the huge global demand for such constituents.
Back in early February, it announced the extension of its strategic partnership with BioNTech to significantly accelerate the supply of urgently needed lipids and increase the quantities to be delivered toward the end of 2021. But the company reported then that having tapped into its two decades long experience in developing and manufacturing lipids, it was able to ensure release nine months ahead of that schedule.
“Our new synthetic cholesterol product is more than 99% pure, offers high batch-to-batch consistency and is scalable under commercial GMP,” said Bulpin.
In January, Merck acquired AmpTec, a Hamburg based mRNA contract development and manufacturing organization (CDMO). That deal also helped advance the early delivery of the cholesterol product.
That PCR technology is a key component of mRNA manufacturing and AmpTec uses a differentiated PCR-based technology for mRNA manufacturing, which has shown to have clear benefits over other manufacturing technologies, said Bulpin.
He told us the combination of AmpTec’s PCR-based mRNA technology with Merck’s expertise in lipids manufacturing is key to “our integrated offering across the mRNA value chain, significantly decreasing supply chain complexity and enhancing speed-to-market.”