Newsletter | April 28, 2022

04.28.22 -- Amgen's Ph3 Biosimilar Stelara Trial Boasts Positive Results
 
Featured Editorial
Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship
 
By Ralph Lambalot, Ph.D., independent consultant

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.
Shared Qualification Audits: A Win-Win-Win Approach
 
By Enith Morillo

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.
Industry Insights
The Path To Commercialization For Wearable Drug Delivery Devices
Article | By Atul Patel, West Pharmaceutical Services, Inc.

Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.
Manufacturing Of Sterile Aqueous Suspensions: A Primer
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. 
Designing Successful Viral Clearance Studies
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.
Unexpected SEC Results: Can It Be Improved?
Q&A | By Jon Lundqvist, Cytiva

Sometimes your size exclusion chromatography (SEC) results don’t look like you want them to. Fix issues such as poor resolution, peak tailing, and fronting with the tips in this FAQ.
News Headlines
Solutions
Large Molecule Biologics Made With Intelligent Collaboration
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