Facilities & Capacity

Regenxbio building Maryland AAV plant to support gene therapies

Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform. The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021. “The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently…

WuXi scouts single-use site for Chinese vaccine joint venture

WuXi Biologics has formed a vaccine production division to service a $3 billion strategic partnership with an unnamed global pharma. WuXi Vaccines is a joint venture between contract development and manufacturing (CDMO) WuXi Biologics and Shanghai-based Hile Bio-Technology. The new entity has been formed to service a Letter of Intent (LOI) inked with a multinational vaccine company. The client has not been disclosed, but WuXi Biologics CEO Chris Chen told Bioprocess Insider the strategic partnership will allow the vaccine developer…

OPUS focus: Repligen expands to support chromatography demand

Bioprocessing vendor Repligen will add eight manufacturing suites to keep ahead of demand for its large-scale OPUS prefilled chromatography columns. During Repligen Corporation’s first quarter conference call, CEO Tony Hunt reported “another great quarter” for its OPUS pre-packed chromatography columns business, with sales up over 40% year-on-year. The firm did not break down how much the business brought in, but total sales at Repligen for the quarter reached $60.6 million (€54 million), up 35% on the same period 2018. “The…

Training and ‘sea turtles’ support WuXi Biologics’ growing China footprint

WuXi Biologics talks Chinese talent recruitment as it begins building an eighth biomanufacturing facility in the country, this one with 48,000 L of single-use bioreactor capacity. The latest addition to contract development and manufacturing organization (CDMO) WuXi Biologics’ bioproduction network is a 1.3 million square-foot center in Chengdu, Southwest China. The facility will include drug development and commercial manufacturing capabilities and boast 48,000 L in bioreactor capacity. According to CEO Chris Chen, the capacity breaks down to 12 x 4,000…

ElevateBio proposes centralized model for cell & gene startups

Neither a CDMO nor an end-user, ElevateBio is looking to change the paradigm in cell and gene therapy development through it’s a centralized R&D and manufacturing model. Recently launched through a $150 million (€134 million) Series A financing, ElevateBio intends to create and grow a portfolio of cell and gene therapy companies using shared expertise and facilities through its R&D, process development and cGMP manufacturing subsidiary Basecamp. “BaseCamp is not a CDMO [contract development and manufacturing organization],” ElevateBio’s CEO David…

CDMO round-up: News from Patheon, Samsung and Sekisui

Patheon will produce an antibody for Cantargia; GI Innovation has signed a second development services deal with Samsung BioLogics; Sekisui Diagnostics is growing its contract microbial manufacturing business. Welcome to Bioprocess Insider’s CDMO round-up. First up in our contract development and manufacturing organization (CDMO) round-up is news from Thermo Fisher’s Patheon, which has been selected to produce CAN04 (nidanilimab) for Cantargia AB. Cantargia already has a contract in place with Celonic (formerly Glycotope Biotechnology) for clinical supply of the monoclonal…

Pfizer opens $200m clinical manufacturing plant in MA

The multiproduct facility will support early-phase manufacturing for its biologics pipeline, Pfizer says. Last week, pharma giant Pfizer cut the ribbon on the latest addition to its biomanufacturing network in Andover, Massachusetts. The Andover Clinical Manufacturing Facility (ACMF) represents an investment of $200 million (€178 million), which includes construction, additional processing equipment and qualification, according to Pfizer spokesperson Samantha Reardon. “The multi-product facility is designed to deliver early phase clinical supplies for Pfizer’s extensive biological portfolio,” she told Bioprocess Insider.…

Vibalogics $1.35m expansion feeds ‘booming’ viral vector demand

CDMO Vibalogics has increased its single-use bioreactor and purification capacity at its site in northern Germany on the back of growing demand for oncolytic virus and viral vector production. The German contract development and manufacturing organization (CDMO) has added a new manufacturing line consisting of a 50 L and 200 L single-use bioreactors and a Siemens process control system at its site in Cuxhaven. The expansion represents an investment of €1.2 million ($1.35 million), Vibalogics told Bioprocess Insider, and also…

Merck injects $1bn into Virginia site to support HPV vaccines

Merck & Co. will invest $1 billion over the next three years to increase production of its human papillomavirus (HPV) vaccine Gardasil at its Rockingham County site. Charlie McCurdy, a spokesperson for Merck & Co., confirmed to Bioprocess Insider his firm has committed to expand the Elkton facility in Rockingham County, Virginia facility to meet global demand for its HPV vaccines Gardasil and Gardasil 9. The $1 billion (€900 million) investment will be spread over the next three years to…

Buoyed by CGT growth, Bio-Techne plans plant to supply $200m of reagents

Bio-Techne will invest $40 million to construct a GMP facility in Minneapolis expected to feed the growing demand for reagents in the cell and gene therapy space. The life sciences services and consumables firm reported a 12% growth in sales year-on-year in its third quarter FY2019 within its Protein Sciences segment. The segment – which supplies proteins such as cytokines and growth factors, immunoassays, antibodies and reagents to the biopharma industry – pulled in $138 million in the quarter. Its…