Biologic Drugs

Choosing the Right CDMO for CGT Programs

October 02, 2022

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Advanced Biopharma Manufacturing Key to White House Cancer Moonshot

September 16, 2022

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

Robust Bioanalytical Studies Can Aid in Regulatory Submissions

September 02, 2022

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Progress in the Development of CAR NK-Cell Therapies

August 03, 2022

Further advances in construct design and manufacturing scalability are still needed.

Formulating Biologics: A Learning Curve

July 03, 2022

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

EMA Recommends Approval of Niemann-Pick Disease Types A/B and B Therapy

May 24, 2022

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

Plan Early: Optimizing Stability During Lyophilization

May 15, 2022

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

Opportunities for Growth and Breakthroughs for Cell and Gene Therapies

May 15, 2022

CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.

Novo Nordisk Announces Positive Scientific Opinion from EMA on Human Insulin

April 25, 2022

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

EC Approves Dupixent for Treatment of Severe Asthma in Young Children

April 12, 2022

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.