ISR Articles

  1. 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..

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Customer Loyalty In Small Molecule Drug Substance Manufacturing 4/15/2019

    In Q4, 2018, ISR surveyed 134 sponsors who outsource drug substance manufacturing for small molecule 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.

  7. Approaches To CMC Involvement Across Drug Development 9/18/2018

    In Q42017, ISR interviewed fifteen tenured CMC professionals at top 50 Pharma companies to learn when during the drug development cycle CMC has its greatest involvement and influence. 

  8. Preferred Pharmaceutical Service Providers Use 11/16/2017

    This infographic provides an overview of preferred provider arrangements with research, software, and manufacturing organizations by presenting data on preferred provider use, quantity, and selection drivers.

  9. Outsourcing Success Requires Constant Evolution

    Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and market research data can help biopharma companies make more informed CMO selection decisions.

  10. Industry Trends In Clinical Development Technology

    As electronic data sources become embedded in the clinical development process, discover how systems, processes, files, storage, and approvals are moving away from paper and becoming dependent on technology applications.