Currently, over 35 CMOs / CDMOs in China claim to offer manufacturing services for biopharmaceuticals. Majority of these (55%) are mid-sized companies (51-500 employees), followed by 24% very large companies (more than 1,000 employees). Examples of such companies include (in alphabetical order) 3SBio, Asymchem, Boehringer Ingelheim BioXcellence, ChemPartner Biologics, GE Healthcare, Merck Millipore, WuXi AppTec, Zhejiang Hisun Pharmaceutical.

 

Among the players that provide biopharmaceutical contract manufacturing in China, majority (77%) provide manufacturing services for proteins / peptides, followed by those having the capabilities to produce antibodies (62%) and vaccines (33%). Further, it was observed that majority of the players (54%) are offering contract services across all scales of operation. This was followed by the companies offering both preclinical and clinical (20%) scales of manufacturing. Further, 10% companies had the capabilities to offer manufacturing services at the preclinical scale only.

 

It is worth highlighting that, majority of the companies (49%) that provide biopharmaceutical contract manufacturing in China are based in the same region as well, followed by those having headquarters in US (23%) and Taiwan (15%).

Further, around 90% of the total Chinese biopharmaceutical contract manufacturers are involved in biopharmaceutical API production. While around 60% are involved in production of biopharmaceutical FDFs and fill / finish / packaging. Moreover, only four companies are involved in production of HPAPIs; these are (in alphabetical order) Asymchem, Levena Biopharma, MabPlex and ScinoPharm.

 

Majority of the Chinese biopharmaceutical contract manufacturers are currently using both mammalian and microbial expression systems for manufacturing biotherapeutics. It has been observed that mammalian systems have emerged as the most desired manufacturing models for the production of complex vaccines. Some of the advantages of mammalian cell lines over other expression systems include:

  • High expression rates
  • Ease-of-culturing and maintenance
  • Protein glycosylation closely resembles that in humans

 

At present, single use technologies appear to be the preferred choice of Chinese CMOs. It has been observed that 31% of Chinese contract manufacturers utilize single use bioreactors, while only 5% prefer stainless steel bioreactors. Further, there are 5 manufacturers that claim to have both of the aforementioned reactors. In addition, industrialists believe that, in the coming years, hybrid technologies, wherein companies can reap the unique advantages of both traditional and novel technologies, are likely to adopted at a faster rate.