Development vs Commercial Outsourced Manufacturing Practices: Biologics

Description

Each year, more CMOs expand their service offerings to include specialized development capabilities, particularly contract manufacturers focused on biologic drugs. Cell line development, process, analytical and formulation development, clinical trial manufacturing and commercial manufacturing for drug substance and drug product may be obtained from a single provider with end-to-end services. Knowing whether this is the best approach for your organization is challenging. This report dives into how the decision-making process differs among drug innovators outsourcing development activities from those outsourcing commercial manufacturing when it comes to CMO/CDMO selection criteria, use patterns, preferences and perceived leadership. Readers will gain insight into four different outsourcing scenarios for biologic drugs enabling them to make more educated purchases of CMO services based on their unique needs. CMOs will gain a better understanding of customers’ requirements and how they change as a compound moves through the development to commercialization process.

 

Development vs Commercial Outsourced Manufacturing Practices: Biologics

Drug Developers

  • Differences in CMO engagement and usage patterns based on outsourcing stage and internal capabilities and/or capacity
  • Key differences in CMO selection drivers based on four different outsourcing scenarios: development-stage API manufacturing, commercial API manufacturing, development-stage drug product manufacturing and commercial drug product manufacturing
  • Learn which CMO attributes are becoming more important to different types of outsourcing peers in order to gain advantages from their experiences

Contract Manufacturers

  • Ways to improve your company’s sales and marketing strategies to specifically address the needs of different customer bases, as identified in CMO selection criteria, during specific decision-making scenarios
  • Outsourcing propensity of the different buyers of outsourced services for both drug substance and drug product manufacturing
  • How CMO awareness, familiarity, leadership, proposal volume, use and preference vary between outsourcers of development-stage or commercial-scale manufacturing in order to target specific audiences with the precise information they need
  • Outsourcing Philosophies and Practices
  • CMO Perceptions and Interactions
  • CMO Selection Drivers
  • Study Data

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  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

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Outsourcing Philosophies and Practices

Primary Section Takeaways
Outsourcing Drivers—Biologic API
Outsourcing Drivers—Biologic Drug Product
Use of Preferred Providers—Biologic API
Number of Preferred Providers—Biologic API
Use of Preferred Providers—Biologic Drug Product
Number of Preferred Providers—Biologic Drug Product
Outsourcing Models—Biologic API
Outsourcing Models—Biologic Drug Product
Outsourced Manufacturing Activities—Biologic API
Outsourced Manufacturing Activities—Biologic Drug Product

CMO Perceptions and Interactions

Primary Section Takeaways
CMO Familiarity—Biologic API
CMO Familiarity—Drug Product
CMO Leaders—Biologic API
CMO Leaders—Biologic Drug Product
Received Proposals—Biologic API
Received Proposals—Biologic Drug Product
CMO Use—Biologic API
CMO Use—Biologic Drug Product
CMO Preference—Biologic API
CMO Preference—Biologic Drug Product
Summary Table—Biologic API
Summary Table—Biologic Drug Product

CMO Selection Drivers

Primary Section Takeaways
CMO Selection Attributes
CMO Selection Attributes Gaining Importance

Study Data

Outsourcing Drivers—Biologic API
Outsourcing Drivers—Biologic Drug Product
Outsourced Manufacturing Activities—Biologic API
Outsourced Manufacturing Activities—Biologic Drug Product
Outsourcing Models—Biologic API
Outsourcing Models—Biologic Drug Product
Use of Preferred Providers—Biologic API
Number of Preferred Providers—Biologic API
Use of Preferred Providers—Biologic Drug Product
Number of Preferred Providers—Biologic Drug Product
Top 5 CMO Selection Attributes—Biologic API
#1 CMO Selection Attributes—Biologic API
Top 5 CMO Selection Attributes—Biologic Drug Product
#1 CMO Selection Attributes—Biologic Drug Product
CMO Selection Attributes Gaining Importance—Biologic API
CMO Selection Attributes Gaining Importance—Biologic Drug Product
CMO Familiarity Among Development Outsourcers—Biologic API
CMO Familiarity Among Commercial Outsourcers—Biologic API
CMO Familiarity Among Development Outsourcers—Biologic Drug Product
CMO Familiarity Among Commercial Outsourcers—Biologic Drug Product
CMO Leaders—Biologic API
CMO Leaders—Biologic Drug Product
Received Proposals—Biologic API
Received Proposals—Biologic Drug Product
CMO Use Among Development Outsourcers—Biologic API
CMO Use Among Commercial Outsourcers—Biologic API
CMO Use Among Development Outsourcers—Biologic Drug Product
CMO Use Among Commercial Outsourcers—Biologic Drug Product
CMO Preference—Biologic API
CMO Preference—Biologic Drug Product

Demographics

Company Type
Headquarters Location
Office Location
Job Title
Decision-making Responsibility
Contract Manufacturing Responsibilities
Involvement in Outsourced Manufacturing
Years of Industry Experience

Additional information

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