Manufacturing Equipment, Biologics

Cytiva’s new facility in Shrewsbury, MA will make equipment such as single-use bioreactors.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The agreement follows a recent announcement that Sartorius plans to invest $100 million in Songdo, South Korea’s bio cluster.

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

Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.

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

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

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

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

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

Ori Biotech is partnering with manufacturers and materials suppliers to develop an automated system for cell and gene therapy manufacturing.

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

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

Single-use and modular systems will meet demand for rapid implementation at different scales.

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.

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

Cloudleaf's Digital Visibility Platform can track which track location and additional environmental information, such as temperature, vibration, and shock, of sensors placed on raw material containers.

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.

Successful process intensification with inline dilution requires effective monitoring and control.

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.

Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.

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 authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.