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Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

Eurofins pumping $5m into a UK biopharmaceutical testing site

24-Mar-2017 - Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.

GSK breaks ground on $175m German Bexsero vaccine facility

21-Mar-2017 - GlaxoSmithKline has broken ground on a €162m ($175m) meningococcal B vaccine production plant in Germany.

EC says separate GMP for cell and gene therapies is necessary

21-Mar-2017 - The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.

PIC/S raises concerns about EC plan for advanced therapy GMP

20-Mar-2017 - Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.

Patheon: Biologics seeds to bloom in 2018 as products shift to commercial

17-Mar-2017 - Patheon says it expects to see a surge in biologics revenue in 2018 as products shift from development stage to commercial.

Reader's poll

American-made biosimilars a differentiator in US market, Coherus

15-Mar-2017 - US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?

GE Healthcare installs purification tech at FujiFilm Diosynth site

15-Mar-2017 - GE Healthcare has completed another tech installation at FujiFilm Diosynth’s biopharmaceuticals facility in Billingham, UK, integrating a single-use purification system with bioreactors it provided in 2014.

$62m injection in Hungary is latest boost for GSK vaccine production

14-Mar-2017 - The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.

Trailer Park Bios? Germfree wheels out mobile cleanroom to fill production gaps

14-Mar-2017 - Florida, US-based aseptic control and biosafety services firm Germfree has launched the latest in its mobile cleanrooms, the Mobile Adaptive Bioproduction Suite.

Pfizer mulls sites for NC gene therapy plant year after Bamboo buy

10-Mar-2017 - Pfizer has confirmed it assessing potential sites in North Carolina for a gene therapy production plant.

BeiGene forms JV to build biologics plant in Guangzhou

08-Mar-2017 - BeiGene Ltd has said it will build a biologics manufacturing plant in collaboration with Guangzhou Development District (GDD).

Repligen to up column production on back of ‘milestone year for chromatography’

08-Mar-2017 - Repligen will boast seven packing suites for its range of OPUS chromatography columns by the end of the month, up from two this time last year.

Russia approves first ever biosimilar of Serono’s MS drug Rebif

03-Mar-2017 - Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).

Jazz: 24/7 production shifts could help stem Erwinaze shortage

01-Mar-2017 - Non-stop production shifts are among initiatives being tested by Jazz Pharmaceuticals to up supply of orphan drug Erwinaze after its CMO received an FDA warning letter.

UK makes validated stem cells available to therapy developers for £500 per vial

01-Mar-2017 - Cell therapy developers can source “regulator ready” stem cells from the UK Stem Cell Bank (UKSCB) for a £500 per vial fee under a scheme announced by the MHRA.

Bio CDMO space: Fujifilm looking to challenge Lonza and B-I

28-Feb-2017 - Fujifilm has separated its biopharmaceutical contracting business in an effort to triple its revenues to ¥100bn ($890m) within seven years.

Aska buys option to commercialize Pieris' potential EPO rival in Japan

28-Feb-2017 - Aska Pharmaceutical Co. Ltd has bought an option to commercialize Pieris Pharmaceuticals’ anaemia candidate and EPO rival, PRS-080, in Japan.

BioMarin building CA plant to support Factor VIII gene therapy candidate

28-Feb-2017 - A Californian manufacturing facility to support clinical development of a haemophilia A gene therapy will be completed this year, says BioMarin.

Sanofi and Lonza JV to build 200 person biologics facility in Visp

27-Feb-2017 - Sanofi and Lonza will construct a large-scale mammalian cell culture manufacturing site in Switzerland, with an initial investment of CHF 290m ($288m).

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