METHODOLOGY

This unique facilities-specific directory includes information obtained through public secondary and primary research, including interviews with industry analysts and participants for relevant facility and company public information. Other commonly-used sources included:

  • Company annual reports, prospectuses, websites, etc.
  • Company financial statements
  • Company press releases, announcements
  • Stock analysts’ assessments
  • Vendor reports
  • Trade periodical articles, industry media
  • Chinese public environmental evaluation reports
  • Facilities construction bidding advertisements (RFPs)
  • Company marketing materials
  • Local governments (Municipal Administrations of Industry and Commerce)
  • Environment evaluation reports
  • Bidding advertisement
  • Presentations at industry conferences
  • Networking (with other experts)

All of the information presented was obtained for publication through interviews, was extracted from public domain sources, or involved analysis of public information by our staff.


Ranking a facility is done quantitatively based on factors including:

  • Total in-use capacity, including equivalent capacity for manufacturing mAbs, (cumulative facility bioreactor volume in Liters) currently online;
  • Capacity under active construction (not just planned);
  • Total Bioprocessing-related staffing for biologics production;
  • Marketed/approved products, in clinical, and in commercial scale. Marketing/approvals can be in any country, and includes biogenerics distributed in lesser- and non-regulated international commerce;
  • Clinical stage products; currently reported in clinical trials or with pending INDs.

These factors are evaluated, and a ranking number is assigned. Of course, all these are subject to change and relative ranking can shift rapidly. However, we believe aggregating these factors moderate the impact of any outlier data point, such as over staffing, or availability of legacy or unused capacity. Products covered, considered in ranking and for which information is presented, are all biopharmaceuticals, particularly cultured therapeutic and prophylactic biologics. Thus, coverage includes recombinant and non-recombinant proteins, monoclonal antibodies (mAbs), vaccines, etc. Blood/plasma-derived products, such as immunoglobulins, are not covered, nor are drugs (chemical substance-based pharmaceuticals), including no coverage of synthetic peptide drugs. Diagnostics are not covered at all, even if involving recombinant protein components. Cellular and gene therapies are within scope of coverage, but essentially none of these companies in China currently have enough manufacturing capacity to rank in the Top 60. Nearly all facilities are involved with recombinant protein, mAbs and/or vaccines.


Products in preclinical stages are not included in the ranking mechanism, and are generally not individually cited within facility entries. Coverage concentrates on the biopharmaceutical manufacturing aspects of facilities, and we present limited information about other non-biopharmaceutical manufacturing capacities or products at that same site. Coverage includes all types bioprocessing, e.g., both mammalian cell culture and microbial fermentation (with bioreactor volumes for these and all other products considered equal).


Most of the listed facilities are currently manufacturing one or more marketed/ approved biopharmaceuticals, although a few product developers lacking marketed/ approved products had enough pilot plant capacity to make the Top 60. Currently, no biopharmaceuticals manufactured in China have yet obtained U.S. or EU approvals, although many covered facilities are US/EU cGMP "compatible" or are working to become a fully US/EU cGMP facility. Readers should keep in mind that China still uses different,often lower, standards for product and facility approvals, compared to the U.S., Western Europe and other highly regulated markets. Thus, GMP approvals in China should not be interpreted as meeting other global standards.