Global CDMOs compete to expand ADC capacities

CDMO companies busy attracting ADC clients

Lonza announces the construction of an additional 1200-liter ADC manufacturing facility in Switzerland

Samsung Biologics announces “Operation of ADC manufacturing facility within the year”... global competition intensifies

Global competition is heating up in the contract development manufacturing organization (CDMO) market for antibody-drug conjugates (ADCs).

 

Major players include Switzerland's Lonza and Samsung Biologics, the world's top two CDMOs, which are competitively expanding their manufacturing facilities.

 

Lonza recently announced the expansion of a 1,200-liter ADC manufacturing facility, while Samsung Biologics announced the start-up of a 500-liter ADC manufacturing facility within the year.

 

According to KoreaBIO, Lonza announced on Dec.

 

13 (local time) that it plans to add 2 manufacturing facilities in Visp, Switzerland, to expand its 'bioconjugation' service.

 

An additional 1,200-liter manufacturing facility will be built to produce commercial bioconjugates, including ADCs, in high volumes.

 

At the same time, the company will expand the infrastructure of the existing facility.

 

Construction is expected to be completed and the facility fully operational by 2028.

 

The new manufacturing facility will provide comprehensive end-to-end lifecycle support.

 

This includes drug manufacturing for early-stage clinical development, large-scale manufacturing for commercial supply, and finished product filling services.

 

Lonza has been in the bioconjugate CDMO business since 2006.

 

To date, it has produced more than 1,-00 cGMP batches for more than 70 programs.

 

Christian Morello, Vice President, Head of Bioconjugates, Lonza, said, “We continue to see strong growth in the bioconjugates space as ADCs and other bioconjugated drugs increasingly progress towards commercialization.

 

This investment in our multipurpose commercial bioconjugation capacity addresses the growing market demand, enables us to support the growth of our customers, and offers a flexible and integrated service for manufacturing bioconjugates.” The global CDMO market, including Lonza, has recently been intensely competing to expand capacities around ADC drugs.

 

Samsung Biologics is building a dedicated 500-liter ADC manufacturing facility at its Songdo Biocampus in Incheon, South Korea.

 

The company plans to finalize the construction this year and begin full-scale operation after receiving GMP approval.

 

Lotte Biologics is expanding its ADC manufacturing facility at its Syracuse, USA plant.

 

This is an investment of USD 80 million (approximately KRW 100 billion).

 

The ADC manufacturing facility is currently being expanded and is targeting GMP approval in the first quarter of next year.

 

The company is also in the process of building a related plant in Songdo, Incheon.

 

In addition, Celltrion plans to establish a separate CDMO subsidiary while pursuing ADC drug development.

 

Kyongbo Pharmaceutical is investing KRW 85.5 billion to build an ADC plant.

 

The reason why domestic and foreign CDMOs are rushing to expand production capacity for ADC drugs is due to their marketability and high barriers to entry.

 

ADC is a type of antibody conjugated with a cytotoxic drug (payload) as a linker.

 

They have a high structural complexity compared to conventional antibody drugs, which makes the development and manufacturing process difficult, but they have emerged as the next generation of biopharmaceuticals due to their relatively high therapeutic efficacy and low side effects.

 

Following the success of Daiichi Sankyo's breast cancer drug Enhertu (trastuzumab deruxtecan), research on ADC drugs has increased explosively worldwide.

 

However, facilities for the development and mass manufacture of ADC drugs have not been able to keep pace.

 

This is why an imbalance between ADC-related research and manufacturing is expected in the field.

 

Unlike conventional antibody drug CDMOs, ADC-specific manufacturing facilities require more particular technologies.

 

Unlike antibody drug production facilities, ADC production facilities must incorporate additional design principles because they handle cytotoxic drugs (payloads) and organic solvents.

 

Additional design details include negative pressure design, differential pressure between cleanrooms, and airlocks to prevent the spread of cytotoxic drugs and protect operators.