Manufacturing Systems, Single-Use

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.

Requirements for virus filtration must be considered in developing continuous downstream processes.

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.

FDA’s 21st Century goals can be realized by using a multi-purpose manufacturing facility with a flexible design that provides reliable production without extensive regulatory oversight.

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

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

A matrix of multi-functional cleanrooms can be adapted for launching products.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

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

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The collaboration will focus on developing manufacturing solutions for biosimilars.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

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.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

The SciLog SciPure FD System from Parker Bioscience is an automated single-use system for the filtration and dispensing of products into either bottles or bags.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

The Flexmag 4050C Electromagnetic Flow Meter from Krohne is suited for biopharmaceutical applications including filtration processes, chromatography, or buffer and media preparation.

Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.

CMOs have been active over the past year in expanding their biologics production and capabilities.

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

The BIOne 1250 bioprocess control station from Distek is a benchtop-scale bioreactor for mammalian and microbial models.

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.

Shipping biopharmaceuticals in single-use containers requires a thorough understanding of the distribution cycle and potential transportation risks.