More Biopharmaceutical Firms to opt for Contract Services
Based on the improvement in outsourced services, the biopharmaceutical industry continues to show a surge in the number of biopharmaceutical firms opting for contract services. CMOs are making enormous investments for the expansion of their manufacturing capabilities. Following are the examples of such investments and expansions:
- In July 2022, Wuxi Biologics announced the expansion of their R&D and large-scale drug product & drug substance manufacturing capabilities in Singapore. This would add 120,000 L biomanufacturing capacity.
- In March 2022, Cambrex, a U.S.-based CDMO expanded its biopharmaceutical testing services business with the addition of 11 cGMP laboratories in its U.S. facility. The expansion included the addition of instruments for nanoparticle size analysis, qPCR, imaging, mass spectrometry, immunoblotting, next-generation sequencing (NGS), and other applications.
Biopharmaceutical CMO & CRO Production Capacity Report Scope
CMO Capacity mapping (for 88 companies)
|
Key Players: Location Mapping & existing Capacities
|
Recent expansions/ Future plans
|
Comparative Heat Map
|
Due to the growing demand for Monoclonal Antibodies (MAbs), manufacturers are facing the issue of production capacity. The construction of a MAb plant costs between USD 20.0 million and USD 60.0 million. The time required to construct a MAb pilot plant is about 2 to 3 years. These factors have led to the rapid adoption of Contract Manufacturing Organization (CMO) & Contract Development & Manufacturing Organization (CDMO) services for the production of MAbs.
Few commercially available MAb products
Product
|
Supplier
|
Bebtelovimab
|
Eli Lilly and Company
|
Abthrax (raxibacumab)
|
GlaxoSmithKline
|
Actemra (tocilizumab)
|
Roche
|
Adcetrisc (brentuximab vedotin)
|
Seattle Genetics
|
AlprolIXd (Factor IX Fc fusion protein)
|
Biogen Idec
|
Arcalyst (rilonacept)
|
Regeneron Pharmaceuticals
|
Avastin (bevacizumab)
|
Roche
|
According to Genetic Engineering & Biotechnology News, there is an increased use of single-use technologies, more flexible & multiproduct facilities, and platform methods & technologies in CMOs, which increase the delivery speed. There will be greater integration of 2,000 L disposable bioreactors, producing higher cell lines and higher capacity chromatography resins, thereby promoting expansions.
With the growing demand for biopharmaceutical contract manufacturing services, several CMOs are expanding their capacity for mammalian cell culture production. There are a number of companies in the space, such as Lonza and Charles River, which offer services for biotherapeutics production using mammalian cell line. These firms are making significant investments in advancing their mammalian cell culture manufacturing facilities for biologics and biosimilar development. For instance, in May 2021, Lonza announced an investment of USD 936 million to expand its mammalian drug substance manufacturing sites in Switzerland and U.S.
Some commercially available biopharmaceuticals and biologics produced using mammalian cell lines
Product
|
Cell factory
|
Biological role
|
Humira
|
CHO
|
Recombinant human monoclonal antibody
|
Rituxan
|
Recombinant humanized monoclonal antibody
|
Enbrel
|
Recombinant soluble dimeric fusion protein
|
Avastin
|
Recombinant humanized antibody
|
Herceptin
|
Recombinant humanized monoclonal antibody
|
Darbepoetin alfa (Aranesp)
|
Hormone
|
Lenograstim (CERBIOS)
|
Cytokine
|
Epoetin alfa (Binocrit)
|
Hormone
|
Ziv-aflibercept
|
Growth factor receptor fused to IgG1
|
Thyrotropin alpha
|
Hormone
|
Trastuzumab biosimilar
|
Monoclonal antibody
|
Remicade
|
Hybridoma cell line
|
Recombinant chimeric, humanized tumor necrosis factor alpha (TNF) monoclonal antibody
|