Author | Feliza Mirasol

MMHGroup

Articles

Biosimilar Quality Requirements

September 15, 2019

BioPharm International

Article

This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosimilar development and characterization process.

Turning to Plant Cell Culture for Sustainability

September 01, 2019

BioPharm International

Article

In an effort to secure a continuous, sustainable supply of an important vaccine ingredient, Agenus is turning to a plant cell-based cell culture method for production.

Design Considerations for a Commercial Cell and Gene Therapy Facility

July 01, 2019

BioPharm International

Article

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.

The Importance of Single-Use Components for Bioprocessing

June 15, 2019

BioPharm International

Article

Simple components help maintain physical integrity throughout a bioprocess setup, and single-use components play a role in ensuring a closed system for aseptic processing.