The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.
|Articles|October 15, 2001
- BioPharm International-10-01-2001
- Volume 14
- Issue 10
Employing Murine MAbs as Ancillary Products in Cell Therapy Manufacturing: Part 1, Considerations for Technology Transfer and Commercial Development
Author(s)Steven Ford, William E. Tente
by Steven Ford and William E. Tente Chimeric Therapies, Inc. Manufacturing processes for murine monoclonal antibodies (mMABs) used in therapeutic applications must address more safety concerns than those used for in vitro diagnostics. Adequate characterization helps ensure that the mMAb retains its functional integrity after more extensive processing.
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A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
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