ISR Articles
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Reasons CDMOs Lose Sterile Injectable Manufacturing Bids
11/13/2020
In Q2 2019, ISR asked 101 respondents who outsource sterile injectable drug product manufacturing what is the main reason a CDMO may lose the bid for an outsourced manufacturing project. Regulatory violations / FDA form 483 warnings topped the list, capturing 25% of respondents’ votes..
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Reasons CDMOs Lose Bioprocessing Bids
9/15/2020
In Q2 2020, ISR asked 100 respondents who outsource bioprocessing what is the main reason a CDMO may lose the bid for an outsourced bioprocessing project. Regulatory violations / FDA form 483 warnings topped the list, capturing 32% of respondents’ votes.
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Trends In Bioprocessing CDMO Selection
8/17/2020
Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.
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ISR's Contract Manufacturing Databook
4/1/2020
It can be difficult to find industry specific, easy to interpret, trustworthy market data. Read the available eBook to discover free drug development and manufacturing facts, figures, and expert perspectives.
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Top Five Oral Dosage Forms By Portfolio Composition
9/12/2019
The top five oral dosage forms account for more than half of products in oral dose portfolios and are: tablets, capsules, controlled release tablets, controlled release capsules, and immediate release tablets.
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How Do Experience And Capacity Impact Small Molecule API Outsourcing?
7/16/2019
ISR asked 60 outsourcers of small molecule drug substance manufacturing to select from four different reasons that manufacturing may be split between in-house and external resources.
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Top Five Satisfaction Drivers For Outsourced Oral Dose Manufacturing
6/14/2019
In Q1, 2019, ISR surveyed 102 sponsors who outsource oral dosage form manufacturing to improve our understanding of what influences customers satisfaction.
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Top Five Satisfaction Drivers For Outsourced Bioprocessing
6/14/2019
ISR surveyed 100 sponsors who outsource bioprocessing to learn what drives CMO satisfaction. Learn why Quality compliance and Technical capabilities and technical service lead satisfaction drivers.
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Customer Loyalty In Biologic Drug Product Manufacturing
5/15/2019
ISR surveyed sponsors who outsource drug substance manufacturing for biologic compounds to gain insight into their CMO loyalty. ISR computes customer loyalty as an index that consists of overall satisfaction, willingness to recommend, and likelihood to use the CMO again.
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Biologic Drug Substance And Drug Product Preferred Provider Use
4/15/2019
ISR data shows the majority of those who outsource biologic drug substance and drug product use a preferred provider approach to outsourcing, and average about four CMOs on their lists.