The art of building a biologic drug

The first biosimilar from Xbrane Biopharma was launched earlier this year, and several more are under development at the company’s facility in Solna, Sweden. “We do everything in-house ‒ from DNA fragments to a final process,” says David Vikström, Chief Technology Officer at the company.

Developing biosimilars is an extremely complicated process, and this is made very clear on a tour of Xbrane’s premises, which occupy floors four and five of two buildings previously used by the Karolinska Institute.

We pass through room after room of sophisticated equipment where cells are grown, harvested, filtered and purified to produce a similar copy of the reference drug, which is followed by almost as many rooms and machines for checking and quality assurance of the results. The company employs around 50 people in research and development.

“We use extremely advanced equipment to develop the best possible process. I can go on and on about machines, but actually, people are everything. It will never work without a good team with the right knowledge and attitude,” says David Vikström.

Biosimilars are copies of biological medicines whose patents have expired. The molecules are very large and complex ‒ a full-length antibody consisting of more than 19,000 atoms ‒ and must be manufactured precisely with the right three-dimensional structure. This must be done using processes and protocols that allow the exact same procedure to be scaled up and implemented in a factory.

Ximluci, the first biosimilar developed in Xbrane’s lab and launched in early 2023, is a biosimilar to the Novartis reference drug Lucentis, which treats various diseases of the retina of the eye.

Next in the pipeline is a biosimilar to Cimzia, a medicine for rheumatoid arthritis. In both cases, these are biosimilars developed using E. coli bacteria.

More projects are underway.

“We are currently scaling up a biosimilar of the cancer drug Opdivo. It is our first full-length antibody, and it is produced in Cho cells (Chinese Hamster Ovary). The process has been moved to the factory now, and we are in the process of scaling it up,” says David Vikström.

The key point of biosimilars is that they push down the prices of specific medicines. According to David Vikström, the medicines can be 30-50% cheaper.

“As a result, either 30-50% more patients can receive the treatment, or the government can reduce its costs by the same percentage. So, there is no doubt that we are working on a good thing.”

David Vikström will speak at New Horizons in Biologics & Bioprocessing at 11.25 a.m. on 14 December.

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