Manufacturing

Articles

The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.

Abzena Invests in New $60-Million CGMP Manufacturing Facility

The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.

Cytiva Invests $500 Million Over 5 years to Expand Global Capacity

Toshihiko Otsubo is principal scientist of Biologics Process Development, 

Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Moritake is associate director of Project Leadership & Operations, 

Pharmaceutical Sciences at Takeda Pharmaceutical.

director and head of Manufacturing Operations of Biogics Process Development

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Proposing a New Method of Detecting Pinholes in Single-Use 

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Facility and equipment design are important, but the team and its experience matter most.

Strategizing for Rapid Changeovers in Biologics Manufacturing

New therapeutics modalities and the need for greater process efficiency are driving technology development.

Chromatographic Science Clarifies Separation Challenges

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow

The new facility in County Mayo includes an ISO class 7 cleanroom for the manufacturing of single-use systems.


Meissner Opens New Manufacturing Facility in Ireland

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis. 

New ASTM Standard Addresses Foreign Particles in Biomanufacturing Processes

Pumps and other components meet the demands of single-use systems in biopharmaceutical downstream processing.

Fluid Handling Considerations

Single-use solutions continue to grow in popularity, largely as a result of the cost and time efficiencies they can afford biopharma companies.


Seeing Success with Single-Use Solutions

The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.

Sartorius Launches New Automated Single-Use Bioproduction Platform

The expansion gives the company diversified capacity running cell production lines featuring Sartorius-brand 2000-L disposable bioreactors and now GE-brand 2000-L single-use bioreactors.

MabPlex Launches New 2000-L Cell Culture Production Lines

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022. 

GE Builds Single-Use Kit Manufacturing Facility in Switzerland

Industry experts debate the pros and cons of “going bigger” than the 2000-L industry norm in a single vessel.

Single-Use Bioreactors: To Scale Up or Scale Out?

The latest advances in upstream technologies include single-use equipment and a protein analyzer for titer monitoring, as well as new plasmid DNA manufacturing capability. 

What’s New in Manufacturing: Upstream Technologies

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

GE Healthcare Life Sciences, Akeso Pharmaceuticals to Accelerate Novel Therapy Manufacturing in China

The company’s Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.

ABEC Launches 6000-L Single-Use Bioreactor

The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.  

Parker Bioscience Filtration Expands Single-Use System Facility in UK

Sartorius Stedim Biotech’s Generation 2 ambr 15 cell culture microbioreactor system offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work. 

Microbioreactor System

Timothy Korwan, Timothy.Korwan@avantorsciences.com, is a director of new product development at Avantor 

Jay Harp, Jay.Harp@avantorsciences.com, is single-use product manager at Avantor

Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.

Manufacturing Systems, Single-Use