Articles

According to the press release, it is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required.

MAVERICK Launched for Real-Time In-Line Monitoring of Multiple Bioprocess Parameters

Feliza Mirasol is the science editor for 

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

FUJIFILM Diosynth Biotechnologies Completes New Viral Vector Gene Therapy Manufacturing Facility in UK

Videos

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)

The AstraZeneca rare disease group hopes to use these new gene therapy programs to bolster its work on genomic medicine.

Alexion Completes Purchase and License Agreement of Rare Disease Gene Therapy Portfolio from Pfizer

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future. 

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

Editor of Pharmaceutical Technology Europe

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance. 

Samsung Biologics Expands Strategic Manufacturing Agreement with Bristol Myers Squibb

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

CN Bio and LifeNet Health LifeSciences Partner to Supply Pre-Validated Cells

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

Leaders at CDER and CBER give update on organizational changes at FDA.

Staying Compliant in 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

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