Newsletter | July 21, 2022

07.21.22 -- EMA Accepts Polpharma's Tysabri Biosimilar MAA for Review

New Podcast Episode
Featured Editorial
Industry Insights
The Path To Commercialization For Wearable Drug Delivery Devices

Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

Top Four Considerations For Tech Transfer Performance

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

A Guide To Accelerating Cell Line Development For Commercial Production

Explore the challenges associated with cell line development in the production of biologics and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.

Risk Management And The Combination Product Testing Strategy

It is essential to have an equal and complete understanding of all components when they come together at the interfaces where the risks are hidden.

Regulatory Convergence With Aurion Biotech

Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach that accounts for every phase of scale-up and commercialization.

Capitalize On Merger/Acquisition: 4 Tips To Consolidate Your CMO Network

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.

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