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Evaluating Scarcity & Value of Sterile Manufacturing FacilitiesTicker(s): TEVA, PFE
Name: Frank Settineri
- 35 years of medical device, pharmaceutical, manufacturing and business expertise ranging from aseptic medical device manufacturing and processing to sterile and non-sterile manufacturing.
- Expertise includes: designing and conducting micro validation for clean rooms/transfer rooms for sterile manufacturers (ophthalmics, inhalation products), Solving potential sterility failure issues for contract manufacturers as well as written responses to 483s and Warning Letters
- First hand experience with Teva/Hospira
Discuss global supply/demand for sterile manufacturing. Is any capacity being shuttered?Added By: hc alpha
What are approximate costs and timeline to build a mid-sized sterile plant? Please cite examples.
Are mid-and-large pharmas outsourcing more or less sterile manufacturing?Added By: hc alpha
Is sterile manufacturing capacity viewed as a differentiated/valuable by mid-and-large pharmas?Added By: hc alpha
Post Hospira/Teva issues, how has FDA regulatory oversight changed?Added By: hc alpha
What key concerns/risks should any investor in a sterile manufacturing business understand?Added By: hc alpha
Why are US-based specialty pharmas outsourcing mostly to ex-US CMOs for these products? And (related), how current is FDA on inspecting these facilities (i.e. Lonza, Corden, etc.)?
How does this tie-in with sterile compounding / outsourcing facilities? (503B)
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