Facilities

UK cell therapy site to help firms avoid failures in “valley of death”

21-Mar-2014 By Gareth Macdonald

Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.

DISPATCHES FROM INTERPHEX

So far, so very good: Pall and ATMI talk integration at interphex

21-Mar-2014 By Dan Stanton

While there will always be space for stainless steel systems, single-use technology is now mainstream according to Pall and ATMI.

DISPATCHES FROM INTERPHEX

To QbD or not to QbD? For biologics it's a must says Cook Pharmica expert

19-Mar-2014 By Dan Stanton

The thorny issue of applying QbD to biopharmaceutical manufacture is a topic of hot debate at Interphex 2014 according to CMO Cook Pharmica.

Start spreading the news, Interphex opens today

18-Mar-2014

When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.

Novo Nordisk invests $100m in diabetes pipeline purification plant

18-Mar-2014 By Dan Stanton

Novo Nordisk has invested 550m Danish Kroner ($100m) to expand a purification plant in Denmark for its diabetes biodrug pipeline.

Patheon and DSM fully complementary for biologics post-merger, says DPx Exec

14-Mar-2014 By Dan Stanton

Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.

Bayer invests $700m in recombinant Factor VIII manufacturing

12-Mar-2014 By Dan Stanton

Bayer is investing over €500m ($700m) in manufacturing recombinant factor VIII (rFVIII) products citing growing demand for long-term prophylactic treatment rather than ‘on-demand’ haemophilia drugs.

Daiichi’s downstream setback cuts Japanese H5N1 vaccine supplies

12-Mar-2014 By Gareth Macdonald

Less H5N1 influenza vaccine than expected will be available in Japan this year after downstream processing problems at a plant being set up by Daiichi Sankyo.

Construction to begin on UK Gov funded bio centre in April

12-Mar-2014

The contract to design and build the UK’s £38m ($63m) National Biologics Manufacturing Centre (NBMC) has been awarded to Interserve.

Thermo Fisher talks Life integration and long-term synergies

12-Mar-2014 By Dan Stanton

An analyst predicts overlap between Thermo Fisher and Life Technologies will present manufacturing, procurement and logistics cost-saving opportunities.

Catalent moves into Japan to manufacture regenerative therapy

11-Mar-2014 By Zachary Brennan

Catalent Pharma Solutions has agreed with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans.

Urbane biomanufacturing: Will making biologics in cities become fashionable?

05-Mar-2014 By Gareth Macdonald

The high street of tomorrow is likely to be a mix of supermarkets, banks and biopharmaceutical manufacturing plants according to one expert who says urban drug production has significant advantages for Pharma firms and patients.

No plans for second Irish plant, says Regeneron

05-Mar-2014 By Dan Stanton

Regeneron has denied it has plans for a fill/finish facility to complement its new $300m (€219m) biomanufacturing plant in Limerick, Ireland.

Demand for plasmid production growing says Cobra Biologics

04-Mar-2014 By Dan Stanton

Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.

US FDA outlines new data requirements for HIV vaccine developers

04-Mar-2014 By Zachary Brennan

The US FDA outlined in draft guidance the ways in which sponsors must submit data for their HIV vaccines and other treatments.

Biosimilar switching: Indiana condones but no big biotech gloom

28-Feb-2014 By Gareth Macdonald

Big Biopharma has backed passage of Indiana substitution laws that require doctors to grant pharmacists permission to switch a biologic for a biosimilar.

AbbVie, Amgen, Roche most exposed to biosimilar competition, Moody’s says

28-Feb-2014 By Zachary Brennan

The biosimilar market is expected to ramp up in Asia and Europe, even as it’s yet to be initiated in the US, with AbbVie, Amgen and Roche’s blockbuster biologics the most threatened, Moody's Investors Service says in a new report.

US FDA offers guidance on analytical procedures and methods validation for biologics

21-Feb-2014 By Zachary Brennan

The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies.

Shire's single-use MA plant receives US FDA approval to make VPRIV

18-Feb-2014 By Dan Stanton

The US Food and Drug Administration (FDA) has approved a second facility for Shire to manufacture its Gaucher disease drug VPRIV.

Diversification and downstream: the 5 problems facing biopharma’s future

18-Feb-2014 By Fiona BARRY

Outdated technology is one of the greatest challenges in creating next-generation biodrugs, says Jonathan Robinson, who is leading the development of a £38m ($63m) national biomanufacturing hub in the UK.

Big Pharma biopharma buyouts boost M&A activity in Q4

14-Feb-2014

Big Pharma takeovers of small biopharmaceutical companies to refill pipelines increased the volume and value of dealmaking in Q4 according to a new report by PwC.

Computer processor to bioprocessor: Regeneron's Irish plant plans revealed

14-Feb-2014 By Dan Stanton

Regeneron has received approval to convert a 400,000 sq ft former computer plant in Ireland into a biopharmaceutical manufacturing facility.

Expert predicts downstream ‘failures’ will be focus of UK hub

14-Feb-2014 By Fiona Barry

Downstream processing techs are harder to use and the focus of less innovation than systems employed upstream says the team developing the UK's new National Biologics Manufacturing Centre.

CalTech pushes farther into HIV-prevention with new gene therapy delivery

14-Feb-2014 By Zachary Brennan

Scientists at Caltech have published a study in Nature Medicine this week demonstrating that a gene therapy technique that boosts a mouse’s protection against HIV also works against HIV that’s transmitted via mucosal surfaces.

Cobra attains QC testing accreditation at Swedish plant

12-Feb-2014

Cobra says it will no longer need to rely on third-parties for its biologics quality control tests after receiving an extension to its GMP certification at a Swedish facility.

Cumbria biopharma plant to create 500 jobs and business ops says GSK

12-Feb-2014 By Gareth Macdonald

GSK has unveiled designs for the £350m ($587m) biomanufacturing plant it intends to build in UK and confirmed that construction will start early next year.

Amgen plant hit with US FDA Warning over Enbrel combination product

12-Feb-2014 By Dan Stanton

The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.

Ireland secures stem cell supplies with new manufacturing centre

12-Feb-2014 By Zachary Brennan

The new Centre for Cell Manufacturing Ireland (CCMI) in Galway means Ireland-based scientists will be able to manufacture culture-expanded stem cells for drug research for the first time.

Pre-emptive state legislation may hinder biosimilar adoption in US

07-Feb-2014 By Zachary Brennan

At least seven states are taking actions that may hinder the substitution of biosimilars for biologics even though the US FDA has yet to approve any.

AbbVie to open $320m Singapore facility with ADC capacity

06-Feb-2014 By Dan Stanton

AbbVie has invested $320m (€432m) into its first Asian manufacturing facility and says it will support an emerging antibody-drug conjugate (ADC) pipeline.

Demand for biosimilar analysis drives BioOutsource to double capacity

05-Feb-2014 By Dan Stanton

BioOutsource says it has quadrupled its revenue from biologics testing and biosimilar characterisation in the last 18 months and is opening a new facility to cope with continued demand.

Pluristem gets German approval for cell therapy manufacturing process

04-Feb-2014 By Gareth Macdonald

German regulators have approved a 3D manufacturing process that Pluristem Therapeutics claims can produce cell therapies faster and more cheaply than standard methods.

Amgen to halt Epogen manufacturing at Colorado plant; 220 jobs to go

04-Feb-2014 By Dan Stanton

220 jobs will be cut as Amgen says it intends to suspend all manufacturing operations at its Epogen (Epoetin alfa) facility Colorado, US.

Sanofi, Transgene to build €10m manufacturing plant for immunotherapy

31-Jan-2014 By Zachary Brennan

Sanofi and French biopharma Transgene will soon begin construction on their new €10m ($13.5m) manufacturing plant, which will produce viral vectors for Transgene's targeted cancer immunotherapy, TG4010.

GSK: Halt in chicken pox vaccine manufacture to continue into Q2

31-Jan-2014 By Dan Stanton

Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.

Double biologics expansion for CMOs Gallus and Cytovance

31-Jan-2014 By Fiona Barry

Contract manufacturers Cytovance and Gallus have both invested millions of dollars in expanding their biologics-manufacturing facilities.

What’s holding up biosimilars in the US? Researchers investigate

29-Jan-2014 By Zachary Brennan

Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.

Lonza confident manufacturing capacity will be filled, post Teva biosimilar JV

24-Jan-2014 By Dan Stanton

The end of Lonza’s biosimilar joint venture with Teva will not affect manufacturing capacity, the firm says, as it reports a drop in overall revenue for 2013.

Provenge CMO PharmaCell contracted for 2nd product

24-Jan-2014 By Gareth Macdonald

PharmaCell, the CMO that makes Provenge for Dendreon in Europe, has agreed to buy a facility from TiGenix to add capacity and a manufacturing contract for a second commercial product.

Calbiotech breaks into antibody manufacture

24-Jan-2014 By Fiona Barry

Immunotherapy contractor Calbiotech has started work on a dedicated mAb plant intended to broaden its biopharma service offering.

Nanotherapeutics opts for GE’s modular manufacturing platform

22-Jan-2014

US defence contractor Nanotherapeutics will use a modular biomanufacturing system provided by GE Healthcare at a facility it is building in Alachua, Florida.

Biocon defends price of biosimilars as it launches Herceptin copycat

21-Jan-2014 By Dan Stanton

Biocon has defended criticism of the high price of its Trastuzumab biosimilar which will become the world's first copycat version of Roche’s Herceptin when launched next month.

Shire takes $650m hit in regenerative skingraft divestment

17-Jan-2014

Shire has divested its regenerative skingraft product Dermagraft to Organogenesis citing a loss of financial incentive due to new Medicare ruling regarding reimbursement.