ISR Articles

31. 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. 

32. Manufacturing Costs For Large Molecule Development Work 10/18/2021

    In Q3 2020, ISR asked 25 respondents to allocate the costs of development work and clinical trial materials for outsourced biologics. The data show that Drug Product Manufacturing captures the largest proportion of expenditure at this stage, followed by API Manufacturing, Process Development and Clinical Supplies.

33. 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.

34. 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.

35. 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.

     
36. The Pandemic's Influence: Biologic Drug Substance Outsourcing Risk 6/14/2021

    How has the pandemic influenced outsourcers' risk mitigation strategies? 54% are increasing contingency planning, 38% plan to increase inventory, and 36% intend to revisit disaster planning.

37. Biologic Drug Substance Outsourcing 5/13/2021

    In Q4 2020, ISR asked 112 outsourcers of biologic API about the proportion of manufacturing allocated across three different approaches to outsourcing: tactical outsourcing, preferred providers, and strategic partnerships. The data show that the largest proportion of work is allocated to strategic partnerships (38%) followed by tactical outsourcing (33%).

38. Large Molecule vs Small Molecule Drug Product Outsourcing 3/16/2021

    In Q42020, ISR surveyed 110 sponsors who outsource biologic drug product manufacturing to gain insight into how drug product outsourcing is distributed at their organizations. 37% of respondents stated a larger proportion of biologic drug product manufacturing is outsourced compared to small molecule drug product. 39% said drug product manufacturing is outsourced at the same rate across molecule types.

39. 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.

40. 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..