Facilities & Capacity

Catalent’s Paragon plans second plant to support Sarepta pipeline

Fresh from an acquisition agreement by Catalent, Paragon Bioservices is seeking to establish a second manufacturing plant dedicated to produce Sarepta Therapeutics’ gene therapy pipeline. Last week, contract development and manufacturing organization (CDMO) Catalent agreed to acquire gene therapy maker Paragon for $1.2 billion (€1.1 billion). Within hours of the announcement Paragon, with Catalent’s backing, said it is seeking to establish a second manufacturing facility at its site in Anne Arundel County, Maryland for the dedicated production of Sarepta gene…

Egg beater: Seqirus goes fully cell-based for seasonal flu vaccine

Seqirus’s vaccine offering for the 2019/20 season will be uniquely cell-base, but the firm says traditional egg-based production still plays a role in fighting influenza. Provided each year by the World Health Organization (WHO) Global Influenza Surveillance and Response System (GISRS), candidate vaccine viruses (CVVs) are the basis for the development and production of seasonal influenza vaccines. For the 2019/20 season, Seqirus has decided to use a cell-based CVV for all four influenza strains recommended by the WHO for its…

Celularity leases NJ plant to make its off-the-shelf stem cell therapies

Celularity says the 147,000 square-foot campus in Florham Park will support its allogeneic placental-derived natural killer (NK) cell therapy candidates, and more investment is to come. Clinical stage cell therapy firm Celularity has a pipeline of off-the-shelf placental-derived Natural Killer (PNK) therapies in development, with its lead program CYNK-001 set to move into Phase II trials for multiple myeloma and acute myeloid leukemia (AML) this year. To support its pipeline, the firm has entered a long-term lease agreement for a…

Sangamo ‘excited’ about Thermo’s takeover of CDMO partner Brammer

Sangamo Therapeutics has secured access to large-scale AAV manufacturing through long-term partner Brammer Bio, a gene therapy CDMO set to be bought by Thermo Fisher. Sangamo Therapeutics has several gene therapy candidates moving through the clinic, including its own programs for inherited metabolic diseases and partnered programs in hematology with Pfizer and Sanofi. To support these, the firm has broadened out its manufacturing strategy by securing access to large-scale adeno-associated virus (AAV) manufacturing through an option agreement with contract development…

Novo Nordisk making good on CAPEX pledge with $100m Danish spend

Novo Nordisk’s Kalundborg, Denmark site produces half the world’s insulin, the firm claims, as it looks to upgrade and expand its facilities. In Novo Nordisk’s end of year report, the firm announced its intentions to invest DKK 9 billion ($1.4 billion) in capital expenditure to reinforce its property, plants and equipment in 2019. This week, the Danish drugmaker made good on DKK 650 million worth of its pledge by announcing plans to upgrade and expand its insulin production site in…

‘Aging’ biotech AgeX to build Cali cell therapy plant

AgeX Therapeutics will construct a cGMP laboratory facility in Alameda, California to manufacture cell lines and its biological aging cell-based product candidates. The biotech firm announced in an SEC filing that it has entered into an agreement to lease 23,911 square feet of space in Alameda, California. The space will be used as AgeX’s principal offices and research laboratory, but the firm also intends to construct a cGMP laboratory facility for the manufacture of cell lines and its cell-based product…

Novartis grabs AstraZeneca’s CO plant and staff for AveXis gene therapy

Novartis has acquired a biomanufacturing facility – earmarked for closure by AstraZeneca – ahead of the potential launch of AveXis’ gene therapy for spinal muscular atrophy, Zolgensma. Since Novartis bought AveXis for $8.7 billion (€7 billion) in May 2018, the Swiss pharma giant has rapidly grown its gene therapy manufacturing network. The latest action sees the firm add the 700,000 square-foot Longmont facility to its AveXis operations in what it says is preparation for the launch of Zolgensma (onasemnogene abeparvovec-xioi1),…

Merck to up drug product capacity by 50% at Swiss site

Merck KGaA will invest €150 million ($168 million) to build a facility with two new aseptic filling lines at its site in Aubonne. For Germany’s Merck, the Aubonne site in Switzerland is its global center of expertise for the production of biotech drug products, carrying out both aseptic filling and packaging operations. The €150 million investment will cover a new building with two new lines for the aseptic filling – one for freeze-dried formulations, one for liquid formulations – of…

bluebird opens gene therapy plant as EMA backs gene therapy

The EMA has recommended approving Zynteglo, bluebird bio’s one-off treatment for beta-thalassaemia. Meanwhile the cell and gene therapy firm has cut the ribbon on a 125,000-square-foot facility in Durham, North Carolina. The EMA’s Committee for Advanced Therapies (CAT) recommended Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – also know as LentiGlobin – today, paving the way for bluebird bio to bring its gene therapy product to market. The product uses a lentiviral viral vector to add functional copies of a…

CDMO Masthercell boosting capacity and adding 150 jobs at Belgium plant

Months after doubling capacity at the Gosselies site, Orgenesis has announced further plans to expand its CDMO Masthercell too feed the demand for cell and gene therapies. Late last year, contract development and manufacturing organization (CDMO) Masthercell unveiled a wing with five cleanrooms at its site in Gosselies, Belgium, which it said effectively doubled its cell therapy production capacity. Four months on and the firm’s parent company Orgenesis has announced another expansion at the site having signed a lease on…