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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
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.
September 16, 2022
The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.
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.
August 03, 2022
Further advances in construct design and manufacturing scalability are still needed.
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.
May 24, 2022
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
May 15, 2022
The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.
CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.
April 25, 2022
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.
April 12, 2022
Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.