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Advanced biologic production involving cell and gene therapies is currently limited but concentrated in Eastern China in provinces such as Shanghai, Zhejiang and Jiangsu for US FDA-approved sites. The Chinese pharma manufacturing industry is renowned for its generic API manufacturing.
Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. Regulatory decisions by the US FDA, EMA and Swissmedic for select therapies from late September to October and the CMOs contracted to manufacture them.
Most pharmaceutical and biotech companies outsource certain production tasks to contractmanufacturing organizations (CMOs). Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions.
In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contractmanufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API.
FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDAapproved Inmazeb for Ebola ( Zaire ebolavirus). Cost of collaboration and contractmanufacturing (COCM). $. Regeneron Pharmaceuticals, Inc. Cost of goods sold (COGS). $.
US President Joe Biden has gained approval from Congress for a new package of aid worth $40bn, and the US government announced last month that it plans to provide an additional $1bn in security assistance to Ukraine. There are no US FDA-approved pharma manufacturing facilities in Russia.
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