Manufacturing Equipment, Biologics

The addition of the two larger-volume bioreactor sizes to Cytiva’s Xcellerex X-platform portfolio will allow scientists and researchers to scale up from 50 L to 2000 L to meet growing demand for clinical trials and regulatory approved products.

Advances in automation technologies and bioprocessing equipment are driving fuller adoption of automation in biomanufacturing.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.

This case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted.

Freudenberg Medical now offers custom single-use assemblies to expand its offerings in silicone extrusion and molding for biopharma applications.

Under the expanded agreement, Univercells and University of Pennsylvania will evaluate certain bioreactors for scalable gene therapy production.

AGC Biologics has completed an expansion at its Copenhagen, Denmark, site, which doubles its bioreactor capacity for mammalian-based cell culture.

Under a partnership, ProPharm and PBL have launched the Cell Factory Box, an enclosed and fully automated cell factory manufacturing device.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

ADC manufacturing facilities are requiring more stringent containment requirements as well as advanced analytical detection.

The Xcellerex magnetic mixer, single-use mixing system was designed to address challenges in large-scale mAb, vaccine, and genomic medicine manufacturing processes.

WMFTS’ new WMArchitect single-use solutions offers standard ready-to-use single-use assemblies as well as customized designs for biopharma fluid management.

Despite a growing trend toward single-use bioreactors, stainless-steel retains its relevance for certain products.

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Challenges in fermentation can be addressed through equipment changes, facility design, and process development.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.

Pharmaceutical Technology Europe® spoke with Fiona Bellot, sales director, Cellexus BioreactorSystems, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

As oligo manufacturers scale up production from lab-scale to clinical and commercial scales, they may require volumes of hazardous materials that drive additional facility design considerations.

SCHOTT now offers ViewCell, a new component meant to add flexibility to biopharmaceutical process control.

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

The bioreactors can integrate with Emerson’s DeltaV PK Controller in addition to S-Series and M-Series controllers.

WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.

The market potential of nucleic acid-based therapies have been pushed into the spotlight following the success of the COVID-19 vaccines.

Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.

In addition, personnel, equipment, and facilities from the acquired companies will expand Reaction Biology’s presence in Germany while enabling its global customers to leverage Bioassay’s expansive portfolio of regulated clinical and commercial services.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.