Newsletter | November 10, 2022

11.10.22 -- Pharma 4.0 Software Methodologies In Biopharma & Medical Devices
 
Featured Editorial
Autonomous Supply Chain Planning Is Within Reach
 
By Elizabeth McGuire and Linda Plumley, Clarkston Consulting

In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
Pharma 4.0 Software Methodologies In Biopharma And Medical Devices
 
By Allan Marinelli and Howard Mann

The life sciences industry has been using computer software validation testing methodology to validate software that is categorized to be GxP in alignment with the principles of good automated manufacturing practices and Industry 4.0 standards. This article discusses the methodologies of computerized system validation, computer software assurance, and the Agile approach.
Industry Insights
Placing Drug Strategies On A Solid Foundation For Success
White Paper | Pfizer CentreOne

Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.
4 Tips To Consolidate Your CMO Network
Article | Pfizer CentreOne

Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.
Mechanistic Modeling: Digital Twins Are Here To Stay
Article | By Tobias Hahn, Cytiva

Expensive and time-consuming laboratory experiments, iterative empirical optimization, and even statistical methods alone are not the answers to the challenges of the future. 
Transition To Closed Processing Systems
Application Note | MilliporeSigma Biosafety Testing Services

Learn about our transition to closed processes for expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.
Growing Complex Generic Application Load May Force U.S. FDA Staffing Changes
Article | By Derrick Gingery, West Pharmaceutical Services, Inc.

Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the COVID-19 pandemic. Learn what forced the agency to lower hiring and retention expectations earlier this year.
Gliding Toward De-Risked Combination Product Development
Article | By Victoria Meyer, BD Medical - Pharmaceutical Systems

Discover how a new product’s role is critical in determining combination products’ exposure to extractables and leachables.
Solutions
Sterile Injectables Made With Intelligent Collaboration
Pfizer CentreOne
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