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Dover shells out $225m for bio-control instruments firm Malema

Biomanufacturing vendor Dover will bolster its Pumps & Process Solutions segment via the addition of Malema’s single-use flow sensor technology. The $225 million cash deal, expected to close in the second quarter, sees Dover add flow-measurement and control instruments maker Malema Engineering Corporation to its service offering. Malema, which is set to make approximately $40-45 million in sales in 2022, produces single-use flow sensors using Coriolis technology which it claims reduces the potential for measurement error and the need for calibration…

Simplifying Biotherapeutic Manufacturing and Quality Control with Label-Free Biosensor Technology

Bio-Layer Interferometry (BLI) systems are used throughout biotherapeutic discovery, development, manufacturing and quality control (QC) workflows to simplify and streamline measurement of process and product attributes. They offer an excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC. These label-free assays can be run fully automated, require much less user intervention, and provide a simplified workflow. Following an introduction to the principles of BLI, we highlight how the Octet® BLI platform has been used…

Inventprise opens Washington pneumococcal vaccine plant

Inventprise will carry out fill-finish for its pneumococcal disease vaccine, IVT-PCV-25 at its newly opened facility in Woodinville. Inventprise, a firm that specializes in affordable vaccines and is supported by the Bill & Melinda Gates Foundation (BMGF), has announced the inauguration of its manufacturing facility intended for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for distribution to low-and-middle-income countries. IVT-PCV-25 is being developed by Inventprise in partnership with non-profit global health organization PATH. According to the firm, the…

Are you meeting quantitative safety standards for residual host cell DNA?

To realize the incredible potential of cell and gene therapies, scientists must overcome many challenges in creating these products, gaining regulatory approval, and ensuring their safe delivery to patients. One persistent challenge is residual host cell DNA contamination, which can arise at multiple points throughout the development and manufacturing process.  HEK293 cells are a dominant platform for cell and gene therapy production because they are highly effective at producing large amounts of recombinant viral vectors. However, if traces of these…

Cytiva opening Swiss single-use cell processing site

With work beginning weeks before the global pandemic, the plant has opened on schedule, boosting Cytiva’s capacity for single-use products aimed at supporting cell and gene therapy makers. The 7,400 m2 facility in Grens, Switzerland is set to have its official opening at the end of the month, strengthening bioprocess vendor Cytiva’s capabilities in providing single use kits for cell processing systems and their relevant consumables. The plant is ready 28 months after Cytiva – then known as GE Life…

EureKING aims to create €1bn+ CDMO via EU SPAC

A group of biopharma pioneers have teamed up to raise $158 million to create a European bio-CDMO.   EureKING, a “blank-check” company — also known as a special-purpose acquisition company, or SPAC — claims to be the first European SPAC in healthcare devoted to biomanufacturing. The company aims to form a contract development manufacturing organization (CDMO) to be listed on Euronext Paris. To do so, eureKING is looking to raise €150 million ($158 million), which could be increased to €165…

Robo-bloc: Multiply labs welcomes Thermo Fisher and Charles River

Thermo Fisher Scientific and Charles River will join Multiply Labs, which aims to develop and validate a robotic manufacturing system that can produce gene modified cell therapies. Multiply Labs founded the robotic cell therapy manufacturing Consortium in 2021 and had initial participation from Cytiva and the University of California, San Francisco (UCSF). Now, Thermo Fisher and Charles River Laboratories have joined as Consortium members. According to Multiply Labs, traditional manufacturing processes can require hours of manual manipulation of cells and…

Regenxbio: ‘CDMO issue validates inhouse gene therapy investment’

Regenxbio will begin inhouse production of material for its Duchenne Muscular Dystrophy (DMD) gene therapy after a quality issue at a third-party manufacturer delayed clinical trial dosing. The initiation of dosing adeno-associated viral (AAV) based gene therapy candidate RGX-202 for a Phase I/II clinical trial has been delayed by between six and 12 months, Regenxbio announced last week during its first quarter 2022 financial results. According to CEO Ken Mills, the delay is due to an issue at an undisclosed contract…

CureDuchenne talks solutions to fill gaps in the CGT space

BioProcess Insider spoke with Michael Kelly, CureDuchenne’s chief scientific officer, to discuss gaps in the gene therapy space and the strategy the firm is adopting to try and fill them. Before joining CureDuchenne, Kelly served in various roles. This includes his position as president and US site head of Renovis, as well as holding senior positions at Amgen, Wyeth (Pfizer), and Wellcome (GlaxoSmithKline). BioProcess Insider (BI): What are the gaps in the gene therapy space? Mike Kelly (MK): Some of…

Matica Bio opens CGT plant, with a little help from G-CON and Sartorius

The CDMO’s facility in College Station, TX consists of modular cleanrooms provided by G-CON and technologies supplied by Sartorius. Contract development and manufacturing organization (CDMO) Matica Biotechnology opened the 45,000 square-foot facility this week to provide viral vectors and cell-based products to cell and gene therapy (CGT) developers. The facility is fully financed by Matica’s parent company – though the size of the investment as not been revealed – and built out from an existing shell using modular cleanrooms from…