Facilities & Capacity

GSK opens $139m Benlysta expansion in Maryland

GlaxoSmithKline has increased drug substance capacity for Benlysta (belimumab) at its Rockville site. It is GSK’s second multi-million-dollar manufacturing project to open within a week In 2017, UK-headquartered Big Biopharma firm announced plans to invest $139 million (€126 million) at its site in Rockville, Maryland to increase the active pharmaceutical ingredient (API) manufacturing capacity for its lupus drug Benlysta. The project has now been completed, upping the Benlysta drug substance capacity at the facility by around 50%. According to Maryland…

From roller bottles to bioreactors: Rentschler building out ex-Shire MA plant

CDMO Rentschler is adding a 500 L single-use bioreactor at the plant it acquired from Shire in January and says further expansions will add manufacturing and lab capacity. Rentschler completed the acquisition of the Milford, Massachusetts biomanufacturing facility from the now defunct Shire in January 2019, marking its first step into the US. The German contract development and manufacturing organization (CDMO) makes the recombinant hemophilia A product Obizur form the facility for Takeda – which bought Shire earlier this year…

Moderna to expand mRNA plant with tech development center

Moderna will build an 85,000 square-foot technical development center at its recently opened manufacturing site in Massachusetts to support its messenger RNA (mRNA) pipeline. mRNA products themselves are neither small molecules nor traditional biologics, but rather a ‘set of instructions’ directing cells to, essentially, ‘use the human body as the bioreactor’ and make the proteins needed to prevent or fight diseases. Moderna Therapeutics has over 20 mRNA-based products in its pipeline, including prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology candidates, and…

Astellas ups MA cell therapy presence with $13m incubator investments

The support of two biotech incubators operated by LabCentral is the latest investment by Astellas Pharma in the Massachusetts cell and gene therapy landscape. Of the $13 million (€11.9 million) investment, $12.5 million will be pumped into a facility being developed by LabCentral in Cambridge, Massachusetts, set to house a lab space for start-up companies to conduct process development studies and a non-GMP pilot plant for cell and gene therapies. The rest of the investment will see Astellas become a…

Vector market moving in right direction: Shortage driving CDMO M&A

Demand for viral vectors has emerged as a major M&A driver in the gene therapy CDMO space says an industry expert. Viral vectors are hollow viruses developers can fill with genetic material. When one of these vectors ‘infects’ a cell the genes inside are inserted and expressed as proteins. Vectors are vital for the production of gene therapies, including new products like Spark Therapeutics’ Luxturna (voretigene neparvovec-rzy) and AveXis’ Zolgensma (onasemnogene abeparvovec-xioi). The problem is that, for the past few…

GSK opens $120m single-use drug substance plant in PA

Equipped with disposable bioreactors up to 2,000 L, the plant in Upper Merion is ready to begin practice runs for GSK’s inducible T cell co-stimulatory (ICOS) receptor-agonist candidate. The site in Upper Merion, Pennsylvania has been a major source of manufacturing for GlaxoSmithKline (GSK) for over 20 years. With the opening of the $120 million (€110 million) ‘next-generation’ facility, the firm says it has created a “technologically-advanced manufacturing hub that offers the flexibility and speed necessary when making today’s complex…

Biocon buys Pfizer R&D plant to bolster 28-strong biosimilar pipeline

Biocon has acquired an R&D plant in Chennai from Pfizer healthcare India and plans to set up the 60,000 square-foot space to support its 28 molecule-strong biosimilar pipeline. Financial details of the acquisition have not been divulged, but a spokesperson from Indian drugmaker Biocon told this publication it has “acquired R&D capital assets from Pfizer healthcare India Ltd.” Specifically, this is a 60,000 square-foot facility at the TICEL Bio Park in Chennai, India, which will be established as a “bench…

Pfizer adds $19m plant in NC clinical gene therapy shake-up

Pfizer will relocate clinical manufacturing activities from its Chapel Hill site to a newly acquired facility nearby in the latest ramp up of its North Carolina gene therapy capabilities. This week, big biopharma firm Pfizer acquired a piece of land and newly constructed building at 1219 Shiloh Glenn Drive, North Carolina – about 2 miles west of Raleigh-Durham International airport – set to become a center of clinical manufacturing for its gene therapy programs. Pfizer confirmed the news first broken…

GE and Germfree in modular gene therapy manufacturing collaboration

GE Healthcare has teamed with cleanroom production firm Germfree to develop a modular biomanufacturing facility for emerging biotherapeutics and gene therapies. Bioprocess vendor GE Healthcare is no stranger to modular manufacturing platforms, with the likes of Bayer, Pfizer and Lonza all opting for its off-the-shelf KUBio platform modular biologics factory. Furthermore, to date 63 manufacturers have selected the firm’s FlexFactory bioprocess platform, which uses predominantly single-use technology. And now the company has partnered with Florida-based Germfree to co-develop a new…

AGC Biologics to exit Berkeley CA plant by end of year

AGC Biologics is undertaking major expansions at sites in Seattle, Denmark and Japan, but the plant in Berkeley no longer fits with the CDMO’s growth strategy. The Berkeley, California clinical biomanufacturing plant will play no further part in the firm’s future, AGC Biologics management told Bioprocess Insider, and will be shut by the end of the year. “Berkeley was no longer the right fit for AGC Biologics,” said CEO Patricio Massera, and so the lease will not be extended into…