Celltrion turns to CDMO Lonza for infliximab biosimilar

Supply of drug substance from Lonza’s stainless-steel facility in Singapore will complement production of Remsima (infliximab) within its own network, Celltrion says.

Remsima is Celltrion’s biosimilar of J&J’s autoimmune best-seller Remicade (infliximab), approved by the EMA in 2013 and by the US FDA in 2016. It became the first biosimilar monoclonal antibody to be launched in Europe in 2015 and according to the Korean drugmaker it captured over 50% of the EU infliximab market by the third quarter 2018.

While the drug substance has been historically produced at Celltrion’s own facilities in Songdo, Incheon, boasting two plants with 190,000 L of stainless-steel bioreactor capacity, the firm has now turned to Swiss contract manufacturing and organization (CDMO) Lonza to expand supply.

Lonza’s site in Tuas, Singapore. Image: Google Streetview

“Lonza’s 20,000 [L scale] fed-batch facility in Singapore will supplement Celltrion’s own capacity. It can offer sufficient capacity for Celltrion,” a spokesperson from the biosimilar developer told Bioprocess Insider.

“The partnership with Lonza was mainly driven by the strategy to ensure we remain flexible to the increasing demands of the biosimilar market.”

Over the past few years, the firm has been flirting with constructing a third facility overseas, but earlier this year announced a U-turn with plans to construct a third factory in Korea with 120,000 L of capacity. Celltrion will still produce Remsima and other biopharmaceuticals from its own commercial facilities in Korea, the spokesperson told us, and the decision to use Lonza will not impact Celltrion’s CAPEX plans.

“This agreement compliments our strategy to maintain flexibility amid the increasing global demands in the biosimilar market. Our current production plans for our own facilities remain strongly intact.”

Lonza and biosimilars

Karen Fallen, head of Mammalian and Microbial Development and Manufacturing at Lonza, was unable to divulge how much capacity at the Tuas, Singapore site would be used by Celltrion.

The site boasts four 20,000 L stainless-steel production lines along with other reactors at various capacities, including a 5,000 L stainless-steel tank for example. Lonza opened a 2,000 L scale single-use facility at the site last year.

With numerous biopharma firms developing infliximab and other biosimilars, we asked Fallen how the CDMO manages potential competition among its clients.

“We consider our existing customers and established relationships very carefully and look at potential new contracts on a case by case basis,” she said.

“Bear in mind there is already considerable existing competition among innovator companies for many targets and indications, for example checkpoint inhibitors in the oncology field. It’s not uncommon to produce several different medicines for the same target/indication and we adhere to strict practices to protect our own and customer’s IP. Having the trust of our customers is a fundamental part of being a CDMO.

“The agreement with Celltrion covers manufacturing of Remsima only and has no effect on other customers in our Singapore facility.”