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Headlines > March 2017

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'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'

Industry needs new bioreactor and monitoring tech for stem cell scale-up, expert

24-Mar-2017 - Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.

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.

US FDA fast-track designation for Humacyte's tissue-based hemodialysis product

22-Mar-2017 - Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.

Amgen targets Roche in Europe with Herceptin biosimilar submission

22-Mar-2017 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.

Goodwin Biotech to work on opioid addiction vaccines project

22-Mar-2017 - Contract manufacturer Goodwin Biotechnology will work with Minneapolis Medical Research Foundation (MMRF) to develop vaccines to treat opioid addiction.

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.

Infographic

Biosimilar interchangeability: Do you know your switching from your substitution?

21-Mar-2017 - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.

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.

Roquette aims to up its biologic reagent presence

17-Mar-2017 - Roquette says investments in packaging, documentation and testing requirements have helped the firm move into the biologics excipient and reagent space.

Lonza launches liver cells for biopharma research

17-Mar-2017 - Lonza has launched a new range of cryopreserved liver cells for biopharmaceutical companies that want to assess the toxicity of their drugs.

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.

FDA grants industry requests for interchangeability guidance comment extension

15-Mar-2017 - The US FDA has extended the comment period for its draft biosimilar interchangeability guidance until May 19.

CDMO 3P selected to scale-up microbial production for Aussie biotech

14-Mar-2017 - Assuring anaerobic conditions in a fermenter design for aerobic organisms will be key in making Ondek’s Helicobacter pylori-based immunotherapy, says 3P Biopharmaceuticals.

$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.

Biosimilars were ‘plan B,’ says portfolio pumped Merck KGaA

10-Mar-2017 - Germany's Merck has confirmed it is divesting its biosimilars division in order to concentrate on its innovative product pipeline.

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.

Horizon inks optimisation tech deal for next generation CHO K1 cell line

10-Mar-2017 - Horizon Discovery Group has teamed up with Amplycell to optimise its GS (glutamine synthetase) null CHO K1 cell line.

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).

Opinion

Roche tops biosimilar defence league by a 'country mile'

08-Mar-2017 - Roche is better positioned than Amgen, AbbVie and Janssen to defend against biosimilar competition, according to this writer and a Twitter poll.

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.

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