Manufacturing Systems, Single-Use

Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.

The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Sartorius has delivered to ABL’s Strasbourg facility, a GMP viral vector manufacturing package solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration, and mixing.

The contract development and manufacturing organization has expanded biologics capacity at its facility in Berkeley, CA.

The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.

The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.

Clover Biopharmaceuticals will use GE's FlexFactory biomanufacturing platform with single-use bioreactors to produce innovative and biosimilar fusion protein products in China.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.

Proper selection and installation optimizes fluid system performance.

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

The Quattroflow QF10k size pump from PSG, a Dover company, has been added to its line of quaternary, four-piston diaphragm pumps.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

The advantages of single-use systems become clear as they become more broadly implemented.

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.

As commercial manufacturing considers single-use materials, a look shows how industry moved to the technology.

Biotech-based therapies and a move to single-use processes highlight recent industry changes.

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.