ISR Articles

31. Understanding CDMO Selections: Getting It Right 3/25/2022

    Learn the importance of identifying CDMO key decision-makers and exploring how they reach determinations that reshape imprecise product-based marketing into messaging that addresses specific customer concerns.

32. Have CDMO Selection Criteria Changed Over The Past Five Years? 3/16/2022

    New relationship dynamics between sponsors and CDMOs contribute to new trends appearing in the outsourced activities and services as well as the way CDMO selection decisions are made. ISR shares how CDMO selection criteria has changed over the past five years and links the attributes to the Life Science Leader’s CDMO Leadership Awards categories.

     
33. Biologic Drug Product Outsourcing Drivers By Company Size 2/14/2022

    The data show that sponsors from large pharma tend to use CMOs to augment internal manufacturing capacity (71%) while sponsors from non-large pharma use CMOs for all manufacturing needs (66%).

34. What's Happening In Cell & Gene Therapy Development? 2/8/2022

    This ISR report provides support and direction for innovative companies looking to outsource aspects of their cell and gene therapy manufacturing and development through shared research highlights.

35. Small Molecule Drug Substance Pandemic Complications 1/14/2022

    Over the past two years, ISR has asked respondents to its annual small molecule drug substance benchmarking surveys whether they encountered pandemic related complications with their outsourced manufacturing. The data show it was slightly more common for small molecule API outsourcers to experience COVID-19 related manufacturing complications in 2021 than during 2020.

36. Biologic Sterile Injectable Outsourcing Volume 11/15/2021

    On average, respondents have 4.5 marketed biologic products, of which 65% of drug product manufacturing is outsourced. Respondents use an average of 3.3 CDMOs. 

37. Using The Same CDMO For Development And Commercial Manufacturing 9/18/2021

    Discover why 80% of survey respondents indicated it is at least moderately important to use the same CDMO for both development activities and commercial manufacturing.

38. Outsourcing Drivers For Small Molecule Manufacturing 7/6/2021

    ISR’s recent survey of small molecule outsourcers found that the majority of respondents outsource for one of two reasons: for all of their manufacturing needs, or to augment their internal manufacturing capacity.

39. Manufacturing Expenditure By Activity 7/6/2021

    Learn about the competitive activities that clinical manufacturing sponsors spend the most money on, while gaining some insight into the clinical manufacturing market and where it’s heading.

     
40. Reasons CDMOs Lose Oral Dose Manufacturing Bids 11/13/2020

    In Q2, 2019, ISR asked 101 respondents who outsource oral dose 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 30% of respondents’ votes.