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Biopharmaceuticals becoming big business

Pipelines

As pharmas evolve into biopharmas drug company pipelines fill with biopharmaceutical products. Here we will track the latest developments, discoveries and products.

DISPATCHES FROM BPI EUROPE 2017

CHO stopper? Biogen looks to alternative cell lines for future of bioproduction

28-Apr-2017 - The Chinese hamster ovary (CHO) cell line is not the future for biomanufacturing says Biogen, which will publish results from a study of alternative hosts later this year.

DISPATCHES FROM BPI EUROPE 2017

Boehringer Ingelheim upping capacity with €700m mammalian cell culture plant

27-Apr-2017 - Boehringer Ingelheim has broken ground on a €700m stainless steel bioproduction facility set to house 135,000L of mammalian cell culture capacity.

DISPATCHES FROM BPI EUROPE 2017

Messenger RNA a ‘game-changer’ for vaccine industry, Sanofi Pasteur

26-Apr-2017 - Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.

Sanfilippo syndrome gene therapy could be filed in US next year, Abeona

11-Apr-2017 - Abeona Therapeutics says it plans to file its single injection adeno-associated virus (AAV) gene therapy for Sanfilippo syndrome in the US in late 2018.

1st Stem Cell Community Day - Hamburg, Germany

Stem cells: Single-use bioreactors and microcarriers can overcome scale-up issues, experts

07-Apr-2017 - The only practical way to scale-up volumes of mesenchymal stem cells (MSCs) is by using microcarriers in single-use bioreactors, say scientists from A*STAR and Instituto Superior Técnico.

Shire success will support polysialic acid drug delivery platform, says Xenetic

06-Apr-2017 - Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.

Dispatches from the 1st Stem Cell Community Day, Hamburg

UK Catapult: QbD and process automation key for making commercial cell therapies

05-Apr-2017 - Process automation should be incorporated early when developing large scale cell therapy manufacturing platforms, according to a lead scientist from the UK Catapult.

US FDA submissions pit Novartis and Kite head-to-head in CAR race

04-Apr-2017 - Novartis and Kite Pharma have both submitted autologous leukemia candidates for review, paving the road for the first available chimeric antigen receptor (CAR) T cell therapy.

UK biotech inks stem cell engineering deal with Singapore researchers

31-Mar-2017 - Plasticell has partnered with Singapore’s Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to advance its stem cell pipeline.

Regeneron and Sanofi's $37,000 per year eczema mAb given US FDA nod

29-Mar-2017 - The US FDA has approved the first systematic treatment for eczema: Sanofi and Regeneron’ monoclonal antibody Dupixent (dupilumab).

'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.

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.

$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.

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.

Kite public offering looks to raise $350m for CAR T cell therapy support

07-Mar-2017 - Kite Pharma has announced a public offering to support commercialisation of its lead CAR-based therapy, axicabtagene ciloleucel.

Vaxess granted $6m to develop sustained release vaccine patches

07-Mar-2017 - Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.

Synagis maker MedImmune teams with Sanofi Pasteur on mAb RSV drug

03-Mar-2017 - Sanofi Pasteur and MedImmune have partnered to develop a monoclonal antibody (mAb) based treatment for respiratory syncytial virus.

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.

Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate

17-Feb-2017 - Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.

Bio-outsourcing share to drop as Big Pharma invests heavily in-house, analyst

15-Feb-2017 - CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.

Lilly rejects reports US tax plan prompted Ireland investment rethink

14-Feb-2017 - Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.

Dutch Biopharma launches Phase III trial of Leukemia donor cell therapy

14-Feb-2017 - Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.

Catalent running its biologics business at over 90% capacity

08-Feb-2017 - Catalent is struggling to keep up with demand for its biomanufacturing services, but a third production train will open up more capacity from October.

Roche: 'Largest biomanufacturing capacity across the industry' to get bigger

07-Feb-2017 - Roche says it will continue to expand its biologics manufacturing capacity while reducing its small molecule network.

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