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Tech Transfer Challenges: From Sponsor to CMO for Aseptic Fill/Finish
- This presentation highlights and discusses considerations for successful tech transfer to a CMO for aseptic fill/finish largely from the perspective of the process engineer charged with leading the tech transfer (ie. process design, batch record development, cGMP production and overall project management). The presentation identifies primary challenges brought on by the tech transfer of the many types of formulation in need of aseptic filling in the industry including liposomal, small and large molecules, cytotoxic/potent compounds, and micronized emulsions. Difficult to fill formulations such as those that are highly viscous are also discussed. You will gain insight to the challenges facing tech transfer from sponsor site to CMO on specific product platform technologies.
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