Facilities & Capacity Archives - Page 57 of 73 - BioProcess InternationalBioProcess International

Alector inks strategic deal with Lonza for early-phase candidates

The changing needs of biopharma have driven some customers towards more strategic development and manufacturing partnerships says Lonza, which has inked such a deal with Alector. The agreement, financials of which have not been divulged, sees biotech Alector secure manufacturing capacity for two of its Phase I neurodegeneration drug candidates at contract development and manufacturing organization (CDMO) Lonza’s site in Visp, Switzerland. Alector has seven immuno-neurology candidates in development. The deal makes use of Lonza’s Ibex Solutions service, launched in July…

Fujifilm CDMO expands further in UK with BioCampus

by BPI Staff

Fujifilm Diosynth Biotechnologies (FDB) will construct a ‘BioCampus’ at its site in Northeast England at a cost of £12.6 million ($16.4 million) The contract development and manufacturing organization (CDMO) has announced plans to build a 42,000 square-foot expansion, set to house 250 staff members and create a further 50 jobs, at a cost of £12.6 million ($16.4 million). “The BioCampus is going to be constructed to transform the Billingham, UK site by building a state of the art office block…

Breathing space: Inhalable biologics interest prompts Intertek expansion

by Gareth Macdonald

Interest in inhaled biologics is increasing says Intertek, which has announced plans to expand its testing facility in Melbourn, near Cambridge. Intertek will double capacity with a new 20,000 square-foot lab kitted out with technologies use to assess inhaled and nasal formulations of large molecule drugs. It also plans to hire 100 employees over the next four years. “As companies are increasingly looking at biologics for non-invasive delivery platforms like inhaled and nasal, there is expected to be an increased…

STC opens GMP biologics plant, eyes commercial and gene therapies

by Dan Stanton

Self-proclaimed ‘boutique CDMO’ STC Biologics has begun initial runs from its newly constructed single-use mammalian plant in Newton, Massachusetts. Contract development and manufacturing organization (CDMO) STC Biologics has undertaken its initial master cell bank (MCB) and three drug substance production runs at its new 3,500 square-foot facility, close to Cambridge, Massachusetts. The plant, which could create up to 30 jobs, brings Good Manufacturing Practice (GMP) manufacturing capabilities to the firm at a 500 L bioreactor scale, expandable to 1,000 L.…

Thermo Fisher allots $125m to expand CDMO buy Brammer

by Dan Stanton

The gene therapy space is growing at an annual rate higher than 25% says Thermo Fisher, which recently agreed to buy CDMO Brammer Bio for $1.7 billion. Thermo Fisher announced last month the agreement to buy contract development and manufacturing organization (CDMO) for $1.7 billion (€1.5 billion), propelling the life sciences services firm into the gene therapy production space. While the deal has not yet closed (expected by end of Q2 2019), Thermo Fisher said on its first quarter financials…

GSK injects $100 in Montana plant to support Shingrix vaccine

by Dan Stanton

GlaxoSmithKline will expand its adjuvant system production capacity at a site in Hamilton, Montana to help feed the high demand for shingles vaccine Shingrix. The $100 million (€90 million) investment at the Hamilton plant will be used to expand the production capacity of key components of the adjuvant system used in several of GSK’s vaccines. “The project involves construction of facilities required to increase adjuvant production, which is a component of some of our vaccines, like Shingrix,” GSK spokesperson Sean…

Novartis prepped for ‘unprecedented’ Zolgensma demand

by Dan Stanton

With over one million square-feet of manufacturing space, Novartis says it is prepared for the imminent approval of AveXis’ SMA gene therapy Zolgensma. Speaking during its Q1 2019 results, Novartis said it is set for the imminent arrival of gene therapy Zolgensma (onasemnogene abeparvovec), added to the firm’s pipeline through the acquisition of AveXis. The one-time therapy targeting spinal muscular atrophy (SMA) Type 1, will be reviewed by the US Food and Drug Administration in May, despite the recent news…

Gilead’s Kite building MD plant to support commercial CAR-Ts

by Dan Stanton

A 20-acre site in Frederick, Maryland will support the production of Kite’s commercial CAR-T therapies, including Yescarta, from 2021. Kite, acquired by Gilead Sciences for US$11.9 billion in August 2017, is one of only two firms to so far see regulatory success for a chimeric antigen receptor (CAR) T-cell therapy. Yescarta (axicabtagene ciloleucel) joined Novartis’ Kymriah on the market after being approved in October 2017. To support Yescarta and its pipeline of CAR-T and T-cell therapies, the firm announced it is…

Catalent’s Paragon plans second plant to support Sarepta pipeline

by BPI Staff

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

by Dan Stanton

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…