Manufacturability of Regenerative Medicine Products for Commercial Scale

Author:

Orchard-Webb David,Robu Irina

Publisher

Elsevier

Reference31 articles.

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3. FDA. (2016). Epicel (Cultured Epidermal Autografts). https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm538540.htm.

4. FDA. (2017) Tisagenlecleucel (CTL019) Novartis. FDA Advisory Committee Briefing Document. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566166.pdf.

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