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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.
FDA is incentivizing drug manufacturers through higher data integrity requirements.
December 02, 2022
The complete online database of ACS Reagent Chemicals is now available.
The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
November 30, 2022
Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.
November 28, 2022
CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.
November 22, 2022
Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.
November 15, 2022
The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
November 10, 2022
The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.
November 09, 2022
The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.
November 02, 2022
New medications show exciting outcomes for weight loss.
November 01, 2022
Industry experts discuss best practices for certificates of analysis.