Emerging New Role Of Contract Development And Manufacturing

Today the global biopharma industry is transcending rapidly. We are seeing ever-increasing efforts in bringing monoclonal antibody-based biologic therapies to market, while some are even conjectured to replace conventional therapy – like in the case of HIV treatment or Ebola with new investigational monoclonal antibody drugs proving to be more safe and also effective in treatment[1][2]. The role of “pure-play” CMOs too is transcending along with the industry.

Conventional CMOs were required to undertake “vanilla” manufacturing to fill the capacity shortfall for developers. In most of the cases previously, the manufacturing and testing processes and procedures were developed and provided to a CMO. But, now there is an increasing expectation from contract manufacturers to support developer programs by undertaking cell line development, process development, or by establishing analytical methods and testing procedures. Hence, in the past 3 decades, CMOs have slowly but surely transformed to being CDMOs through vertical integration[3]. In the current era – an idea in the field of novel biologics research is actualized with the help of CDMOs’ execution skills and experience.

According to research conducted by Ernst and Young, another trend that is being observed is more and more no. of specialty CDMOs are coming to the fore. Specialty CDMOs have a strong focus on one of the segments of the value chain eg, fill-finish for sterile injectables, monoclonal antibody development, formulation development, or monoclonal antibodies’ contract manufacturing. The specialty CDMOs have superior technological knowledge, long market standing, or mastery of regulatory requirements in that area. Such a competitive edge soon becomes specialty CDMO’s unique selling point [4].

The CDMOs flexibility in undertaking manufacturing or development projects or in willingness to make technological upgrades are critical for researchers today because each project can be highly customized.

REFERENCES

1. https://www.mdedge.com/infectiousdisease/article/131950/hiv/antibody-could-replace-conventional-antiviral-therapy-hiv
2. https://www.nih.gov/news-events/news-releases/investigational-monoclonal-antibody-treat-ebola-safe-adults
3. https://bioprocessintl.com/manufacturing/manufacturing-contract-services/from-cmo-to-cdmo-opportunities-for-specializing-and-innovation/
4. Consolidation of the CDMO industry: opportunities for current players and new entrants; Ernst & Young