Manufacturing Systems, Single-Use

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

Cytiva is adding process development, media and assay development, and contract development services at its facilities in Korea, Japan, Sweden, and the UK.

Set to be operational by the first quarter of 2022, the 140,000-ft2 facility will feature up to six 2000-L, single-use bioreactor systems along with additional harvest and purification equipment to produce up to 100 commercial batches annually.

Biopharma can apply new manufacturing practices adopted during the COVID-19 pandemic to enhance bioprocessing.

The new line of Defined Tubing Routing (DTR) from High Purity New England is a flexible tubing support system for single-use biopharmaceutical manufacturing.

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 manufacture of gene therapy vectors is shifting to more modern technologies.

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

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

Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service

Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.

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

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

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

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.

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

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.

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

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.

The ChargePoint Single Use Passive and ChargeBag create a single-use system for contained and sterile transfer of pharmaceutical powders between process steps or facilities.

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.

Distek, a provider of laboratory testing instruments, added a dual impeller single-use bioreactor (SUB) system to its BIOne portfolio.

Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.

Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.

Suppliers address complex supply chains for global biopharmaceutical manufacturing using disposable components.

The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.