Facilities

European manufacturing waiver to ‘level the playing field’

18-Feb-2019 By Ben Hargreaves

The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.

FDA observes manipulation of data at Immunomedics facility

14-Feb-2019 By Ben Hargreaves

Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.

Bringing gene therapy manufacture in-house avoids ‘imbalanced’ CMO relationship

28-Jan-2019 By Ben Hargreaves

The explosion of the gene therapy industry is leading to supply issues, which has led one company to view producing its own clinical materials as its best option.

Five reasons biologics contract manufacturing will hit $87.6bn by 2027

25-Jan-2019 By Ben Hargreaves

The contract market for bringing biologics through the pipeline to commercialisation is growing at a rapid clip, with a recent report suggesting a high CAGR in the sector.

GE Healthcare and G-CON create platform for advanced therapy production

24-Jan-2019 By Ben Hargreaves

GE Healthcare and G-CON have combined capabilities to offer drug developers ‘readily deployable’ manufacturing platforms for cell therapies and viral vectors.

Immunomedics receives FDA complete response letter

24-Jan-2019 By Maggie Lynch

Immunomedics received a complete response letter from the US FDA for its BLA seeking approval of its biologic, sacituzumab govitecan.

Boehringer expands commercial biologics production capacity in China

22-Jan-2019 By Ben Hargreaves

Boehringer will increase its capacity for commercial manufacturing of biologics at its Shanghai, China, facility.

UPDATE

Industry in conflict over generic and biosimilar manufacturing waiver

22-Jan-2019 By Ben Hargreaves

European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.

AZ to close two facilities in Colorado

15-Jan-2019 By Ben Hargreaves

The UK company will close two facilities in Boulder and Longmont eliminating 210 positions.

Catalent to double biomanufacturing capacity with $200m investment

10-Jan-2019 By Ben Hargreaves

Catalent will use the funds to enlarge drug substance manufacturing and drug product fill/finish capacity.

Fujifilm invests $112m on two fronts with new site and expansion

08-Jan-2019 By Ben Hargreaves

Fujifilm has launched an upgrade to its subsidiaries manufacturing capabilities, by increasing capacity by 50% at an existing facility and building an entirely new site for cell technology.

Novartis makes acquisition to buildout CAR-T capabilities

02-Jan-2019 By Ben Hargreaves

Novartis will acquire French CDMO, CellforCure, to expand its cell and gene therapy manufacturing network.

Biologics CDMO buys Shire Massachusetts facility

02-Jan-2019 By Staff Reporter

Rentschler Biopharma will buy Shire’s development and manufacturing facility in Milton, Massachusetts, where the latter makes haemophilia A product, Obizur, for commercial production.

Watch out for the ‘scale and speed’ of transformation in China, says Sanofi exec

19-Dec-2018 By Ben Hargreaves

Transformation in cell therapies is happening at an even faster rate than the US, suggests Christoph Heinemann of Sanofi.

NEWS IN BRIEF

Biologics CDMO completes €5m expansion in Spain

18-Dec-2018 By Staff Reporter

Biologics and cell therapy CDMO, 3P Biopharmaceuticals, has expanded its facility and capabilities in Pamplona, Spain.