Manufacturing, Continuous Biologics Processing

Sara Fathollahi, PhD, product application specialist at DFE Pharma, points out important redesign concepts critical to adapting continuous manufacturing.

SCHOTT now offers ViewCell, a new component meant to add flexibility to biopharmaceutical process control.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.

The adoption of perfusion cell culture continues to advance with the help of PAT tools.

As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Sanofi’s Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, MA was named the Overall Award winner at the ISPE virtual annual meeting.

PAT advances are enabling improved process understanding, process control, and error prevention.

It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.

Better understanding and control of cell behavior is yielding benefits, upstream and beyond.

GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.

Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Real-time monitoring of product- and process-related impurities remains a challenge.

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.

The learning curve for process analytical technology has slowed widespread adoption.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

A look at the Univercells' NevoLine bio manufacturing platform, which incorporates principles of automated and continuous bioprocessing.

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

A continuous peptide manufacturing process invented by Swedish Biomimetics 3000 Ltd is a platform technology also applicable to other solid-phase chemical processes, such as chromatography.

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.