Manufacturing Systems, Single-Use

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

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

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

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

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

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

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

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

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

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

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.

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

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

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.

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

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

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

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.

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

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.

Single-use systems offer a solution to the challenges inherent in buffer preparation, which can be the cause of bottlenecking in bioprocessing.

Single-use systems may offer a suitably flexible solution to the biomanufacturing challenges of cost and time-to-market.

This article provides a review of various 2000-L single-use bioreactors used by biopharmaceutical suppliers for commercial production.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

The expansion will increase the company’s single-use capacity to meet growing demand.