Upstream & Downstream Processing

Collaboration Aims to Address Large DNA Plasmid Scale-Up Issues

CDMO Biomay has teamed with BIA Separations to tackle bottlenecks in the cell lysis and purification stages of large DNA plasmid production. Chromatographic column maker BIA Separations will work with Biomay to develop a high yield and purity manufacturing process for ‘large’ plasmid DNA used for therapeutic application. Large plasmids are commonly used as starting materials for manufacturing of viral gene therapy vectors, said Hans Huber, COO of Biomay. “For instance, manufacturing of the adeno-associated viral vector system (AAV) requires three…

Rise of the Insects: Thermo Fisher Hails Non-Mammalian Expression for Vaccines

Encouraged by success of Flublok and Cervarix, Thermo Fisher says insect protein expression systems are one of the most promising technologies being used in the development of next-generation vaccines. Thermo Fisher has launched the Gibco ExpiSf system, an insect protein expression system aimed at generating baculovirus using a suspension-based transfection protocol it says delivers protein in half the time compared to traditional insect platforms. BioProcess Insider spoke with Amy Butler (AB), vice president and general manager, Cell Biology at Thermo…

Repligen Reports Record Revenue, Continues on M&A Hunt

Repligen will launch several new filtration and chromatography offerings this year as its strategy of developing products based on technology acquisitions pays off. For the first quarter 2018, Repligen Corporation reported record revenues of US$45 million (€38 million), up 46% on the same period last year. The bioprocessing company attributed the results to strong sales of its filtration and chromatography products – up by over 90% year-on-year – bolstered by the $359 million acquisition of Spectrum in June 2017. “Our…

Lonza Building Hybrid Biomanufacturing Plant at NH Site

Lonza plans to bolster its mid-scale biomanufacturing and cell therapy capabilities at its site in Portsmouth, New Hampshire on the back of growing demand. The expansion will include mid-scale mammalian capacity through the installation of several 6,000 L bioreactors which will eventually replace stainless steel 5,000 L systems operating at the site. “This will be a hybrid facility combining stainless steel for the main reactor with single use technologies for some of the upstream and downstream processing,” Sylke Hassel, SVP…

Catalent’s Next 5 Years: Biomanufacturing Demand to Outstrip Supply

Catalent says it is evaluating separating out its biologics business after investments and M&A have propelled the CDMO out of the sub-5,000 L space. Catalent has reported revenues of US$628 million (€524 million) for its third quarter fiscal 2018. The contract development and manufacturing organization (CDMO) attributed 18% year-on-year jump to “robust organic growth” in its biologics business and the acquisition of Cook Pharmica last October. The $950m deal added an 875,000ft2 production and fill/finish site in Bloomington, Indiana, complementing…

WuXi Biologics Takes ‘First Giant Step’ Out of China with 54,000 L plant

WuXi Biologics will invest €325 million (US$390 million) in its first production site outside of China. The Irish site will be fully disposable, the CDMO told BioProcess Insider.   The contract development and manufacturing organization (CDMO) is looking to construct a single-use site with 54,000 L of disposable bioreactor capacity through a €325 million investment in Mullagharlin, County Louth, Ireland. When GMP ready in 2021, the site will be equipped with twelve 4,000-L fed-batch bioreactors and six 1,000-L bioreactors for…

Patheon Doubling Global Biologics Capacity in $50 Million Missouri Spend

Thermo Fisher’s CDMO business Patheon will add 16,000 L of single-use capacity through a US$50 million (€41 million) expansion at its St Louis facility. Contract development and manufacturing organization (CDMO) Patheon will expand its St Louis, Missouri bioproduction site by 64,000 ft2 on the back of what it says is “extremely strong growth in demand”  for commercial biologic manufacturing. The facility was added to Patheon’s network through the 2014 acquisition of Gallus Biopharmaceuticals. The investment will not only add 16,000…