Biologic Drugs

Safeguarding Biologics—Blending Engineering Ingenuity and Managerial Excellence

February 03, 2023

Efforts to optimize the delivery of sensitive biotherapeutics continue to evolve.

Opening Up Opportunities in 2023

January 03, 2023

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Frontrunners in the Latest Stem Cell Technology

January 02, 2023

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

Getting Personal for Blockbusters in 2023

January 02, 2023

The latest report from Clarivate has been published, highlighting 15 potential blockbusters to watch out for in 2023, the majority of which are personalized medicines.

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.