Newsletter | September 15, 2022

09.15.22 -- De-Risking Biosimilar Development With A Suitable Autoinjector

 
New Podcast Episode
Featured Editorial
Industry Insights
Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

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.

De-Risking Biosimilar Development With A Clinically Validated And Commercially Proven Disposable Autoinjector

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

How To Use QbD Software To Improve An Existing Identification Method

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

Learn About Affinity Chromatography Using Tagged Protein Purification

Choosing the right tag is essential to getting the purity, solubility, and protein quality your application needs. Learn how to prepare a recombinant protein in the quantity and quality you need.

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