Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.
Throughout the pandemic, the FDA has demonstrated more than ever the value of using a risk-based approach to inspectional activities, which must be embraced and mirrored in industry when it comes to supplier and vendor audits, especially by early-stage pharmaceutical companies.
White Paper |
By Omar A. Salman, Ph.D.,Pfizer CentreOne
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
Application Note |
By Kathryn Martin Remington, Ph.D., and Kate Smith,MilliporeSigma (Product Characterization)
A review of studies that involve scaling down individual process steps, and, for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.