The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

The companies will advance the development of Innovent’s ADC candidate, IBI3009, which has received IND approvals in the US, China, and Australia.

FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.

The BioPharm International® editors present our most popular technical articles from 2024.

Atul Mohindra, head of Biologics R&D at Lonza, discusses the challenges and successes of bispecific antibodies as well as the field’s future direction from a CDMO perspective.

Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.

BioPharm International® spoke with Paul Mugford, director, Biologics Process Development at BIOVECTRA, to find out what approaches works best for optimizing processes in microbial fermentation.

The BioPharm International editors present our most popular video interviews from 2024.

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

BioPharm International® spoke with Sujay Jadhav, CEO of Verana Health about trends in real-world data and the impact these trends will continue to have on the pharmaceutical industry in 2025.

Optimizing the harvest of viral particles is important for the yield and purity of the final product.

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.

Pointing to the continued circulation and evolution of COVID-19, WHO published a statement on the COVID-19 vaccine antigen composition to respond to variants of the virus.

With the launch of its cobas mass spectrometry solution, Roche brings fully automated mass spec analysis to the clinical lab.