Facilities

Cell-culture flu vaccines shipped from Novartis plant for 2014-5 season

26-Sep-2014 By Dan Stanton

Novartis has shipped the first of its cell-culture - rather than chicken egg - based vaccines for the 2014-2015 flu season from its North Carolina facility.

TC BioPharm constructs clinical manufacturing facility in Scotland

26-Sep-2014 By Zachary Brennan

Scotland-based TC BioPharm has completed its work on a clinical manufacturing facility in Glasgow.

Two more biotechs for GSK and venture capital portfolio

24-Sep-2014 By Fiona BARRY

GSK and venture capitalists Avalon have launched two early-stage R&D biotechs in San Diego, California.

Emergent scales up manufacturing of anthrax vaccine

24-Sep-2014 By Zachary Brennan

Emergent BioSolutions has initiated a non-clinical study to demonstrate it can scale-up production of its anthrax vaccine, BioThrax, without making it less effective.

Production on hold at GSK vaccine plant after poliovirus enters water supply

23-Sep-2014 By Dan Stanton

GlaxoSmithKline will not restart production at a vaccine plant in Belgium until an independent investigation determines how liquid contaminated with polio virus was released into the local sewage system.

RLS to make India's first Remicade biosimilar for Epirus and Ranbaxy

23-Sep-2014 By Dan Stanton

Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.

Boehringer Ingelheim licenses CureVac mRNA vaccine for up to $600m

23-Sep-2014 By Zachary Brennan

Boehringer Ingelheim will pay mRNA drug developer CureVac up to €465m ($600m) for an exclusive global license and development collaboration on CureVac’s potential mRNA vaccine in early clinical development for the treatment of lung cancer. 

Merck KGaA is latest bi-curious antibody developer in ADC deal with Sutro

17-Sep-2014 By Gareth Macdonald

Merck KGaA has partnered with bispecific antibody firm Sutro Biopharma to develop and produce antibody drug conjugates (ADCs).

Biosimilar mAbs to cut Europe's healthcare bill by €20bn by 2020

16-Sep-2014 By Gareth Macdonald

At present Biosimilars save Europe roughly €2.40 per person, or €1.8bn a year, but by 2020 follow-on mAbs alone will shave €20bn off the continent’s healthcare bill according to researchers.

Baxter to spin off biopharma assets to form new ‘Baxalta’

12-Sep-2014 By Zachary Brennan

Baxter International will spin off its biopharmaceutical treatments and manufacturing facilities to form a new company known as Baxalta, which is expected to launch in mid-2015.

Seattle Genetics, Genmab enter ADC collaboration worth up to $211m

12-Sep-2014 By Zachary Brennan

Seattle Genetics and Genmab have entered into another antibody-drug conjugate (ADC)partnership under which Genmab will pay $11m upfront for use of Seattle’s auristatin-based ADC technology. 

infographic feature

Better together? biosimilars sector says aye

10-Sep-2014 By Gareth Macdonald and Dan Stanton

Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist overlords, there is an Art Garfunkel or Daryl Hall solo album to illustrate the positive impact collaboration can have.

Analyst: CMOs to prosper as biopharma reduces capacity sharing

09-Sep-2014 By Dan Stanton

Biopharma firms are no longer offering spare capacity to rivals, according to an analyst, who says the trend is benefiting large CMOs.

NICE result for Soliris, but no justification for high manufacturing costs

05-Sep-2014 By Dan Stanton

The monoclonal antibody drug Soliris has been recommended by NICE despite Alexion failing to justify the manufacturing costs contributing to the £3,150 ($5,140) price per vial. 

Yearning for Yen? Merck Millipore bids to boost Japanese biz with test centre

27-Aug-2014 By Gareth Macdonald

Merck Millipore has set out to win more biomanufacturing business in Japan by consolidating testing and technical operations in the country into a newly expanded Tokyo training hub.

Patheon propels itself into US biologics market in Gallus acquisition

27-Aug-2014 By Dan Stanton

Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.

Reinspection lands Alexion with 483 for Soliris plant

26-Aug-2014 By Dan Stanton

A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

EMD Millipore to supply Samsung's Yervoy plant in 10-year deal

26-Aug-2014 By Gareth Macdonald

EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Correction

GE Healthcare: plans to move New Jersey ops to new Massachusetts HQ

22-Aug-2014 By Gareth Macdonald

GE Healthcare has said it plans to relocate operations in New Jersey to its new Massachusetts life sciences headquarters.

Progenics selects Gallus to manufacture its mAb in Phase II trial

22-Aug-2014 By Zachary Brennan

Oncology-focused Progenics Pharmaceuticals has selected CMO Gallus BioPharmaceuticals to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate. 

Vast majority of ADC manufacturing outsourced, report finds

22-Aug-2014 By Zachary Brennan

Between 70-80% of ADC (antibody drug conjugate) manufacturing is performed by CMOs, according to a new report.

G-CON's containment PODs launched in response to Ebola crisis

20-Aug-2014 By Dan Stanton

G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.

Novartis invests $35m in stem cell tech company with option to acquire

20-Aug-2014 By Zachary Brennan

Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.

For single-use, 2,000 litres is Fujifilm's limit as it invests in US and UK

19-Aug-2014 By Dan Stanton

Single-use bioreactors do not need to be bigger than 2,000L says Fujifilm Diosynth, which is investing in such technology at plants in the UK and US

Miltenyi Biotec acquires lentiviral vector manufacturing business of Lentigen

19-Aug-2014 By Zachary Brennan

Miltenyi Biotec has acquired the lentiviral vector manufacturing business and related assets from Lentigen, a lentiviral technology provider for cell and gene therapy applications.

Japanese biotech adopts MES at recombinant flu vaccine plant

15-Aug-2014 By Zachary Brennan

Japanese biotech company Unigen has implemented in only four months Werum's PAS-X Manufacturing Execution System (MES), which can help optimize production output at the world’s largest plant for the contract manufacturing of recombinant flu vaccines.

US FDA outlines manufacturing-focused stem cell research efforts

13-Aug-2014 By Gareth Macdonald

US FDA researchers are developing tools to help cell therapy developers improve how they manufacture stem cells in a new lab consortium unveiled by the agency this week.

Health Canada signs off on action plan for GSK flu vaccine plant

13-Aug-2014 By Zachary Brennan

Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.

China Biologic Products set to make clotting aid post CFDA inspection

12-Aug-2014 By Dan Stanton

China Biologic Products is set to become the second Chinese producer of a prothrombin complex concentrate (PCC) blood clotting product following an inspection by the CFDA

Biopharma companies race to develop Ebola vaccine

12-Aug-2014 By Zachary Brennan

As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.

Carbogen Amcis takes over Swiss plant to boost ADC offering

08-Aug-2014 By Dan Stanton

Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.

Competition heats up for insulin biosimilar market, scientist says

06-Aug-2014 By Zachary Brennan

With the EMA’s CHMP (Committee for Medicinal Products for Human use) recommending approval for a new insulin biosimilar early last month, some in the industry are expecting an increasingly competitive field moving forward.

Kentucky firm ramps production of plant-based antibodies used to treat two Ebola patients

06-Aug-2014 By Zachary Brennan

Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.

Pfizer buys Baxter's vaccine business plus Austrian plant for $635m

30-Jul-2014 By Dan Stanton

Pfizer has agreed to pay $635m (€474m) to Baxter International for its vaccine business, including two marketed products and a facility in Austria.

Amgen makes room for biosimilars despite cutting manufacturing 23%

30-Jul-2014 By Dan Stanton

Amgen says it will continue to invest in manufacturing technologies to support its biosimilar pipeline despite announcing a restructuring that will reduce its manufacturing footprint by 23%.

PaxVax acquires typhoid vaccine, Swiss manufacturing facility

29-Jul-2014 By Zachary Brennan

Specialty vaccine company PaxVax has acquired the oral typhoid vaccine Vivotif from Crucell, as well as its manufacturing facility in Thörishaus, Switzerland. Financial terms of the transaction were not disclosed.

Busy times: US FDA accepts Sandoz's biosimilar filgrastim filing

25-Jul-2014 By Gareth Macdonald

Mailroom and legal staff at Sandoz and Amgen are in for a busy six months after the US FDA agreed to review a biosimilar version of the anti-infective, Neupogen.

Brazilian JV looks to tap plant-based manufacturing system for biosimilars

23-Jul-2014 By Zachary Brennan

Biologic manufacturer PlantForm and PharmaPraxis have established a joint venture to develop, manufacture and commercialize biosimilar versions of six key biopharma treatments.

Novartis sees biosimilars growth as a driving force in Q2 results

18-Jul-2014 By Zachary Brennan

With almost three decades of recombinant protein production experience, Novartis is now seeing its work paying off as its biosimilars grew by 23% over the same quarter last year to $420m (€310.5m) in Q2.

Consultant: For CMO selection, its the (molecule) size that counts!

16-Jul-2014 By Dan Stanton

The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.

Shire's Board succumbs to AbbVie's $53bn bid

16-Jul-2014 By Dan Stanton

The acquisition of Shire for £31bn ($53bn) has moved a step closer but reliance on third party suppliers would only add two facilities to AbbVie's biomanufacturing network.

update

WHO praises China vaccine rules and flags country as future supply hub

16-Jul-2014 By Gareth Macdonald

Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.

Indian budget sets out country's biotechology drive

11-Jul-2014 By Dan Stanton

India is looking to stimulate investment in biotechnology through bioclusters and development of the International Centre for Genetic Engineering and Biotechnology (ICGEB).

UK to set up personalised meds focused manufacturing tech test centre

11-Jul-2014 By Gareth Macdonald

A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).

FDA approves Protein Sciences’ cell-based flu vaccine for 2014

11-Jul-2014 By Zachary Brennan

The FDA has approved Protein Sciences’ strain change amendment for its cell-based seasonal influenza vaccine known as Flublok.  

60-year old smallpox found in US FDA lab may still be viable, if only live vaccines lasted as long

09-Jul-2014 By Gareth Macdonald

For live vaccine manufacturers working to extend shelf-life, the discovery that 60-year old smallpox virus found at a US Food and Drug Administration (FDA) lab could still be viable will be as galling as it is worrying.

Fourth times the charm? Abbvie re-ups offer to buy Shire for £30bn

09-Jul-2014 By Zachary Brennan

AbbVie has once again raised its bid to purchase Shire – this time by about 11% to £30.1bn ($51bn).

BioOutsource targets biosimilars testing growth with new US lab

01-Jul-2014 By Gareth Macdonald

US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.

Fujifilm buys TAP bioreactor for UK manufacturing plant

27-Jun-2014 By Gareth Macdonald

Fujifilm Diosynth Biotechnologies has expanded process development capacity at its site in the UK with a new $5.6m investment and a TAP bioreactor.

Industry and EC to meet to discuss better biopharma access to cash

27-Jun-2014 By Gareth Macdonald

European biopharmas trying to avoid “death valley” went to California this week according to industry groups, investors and officials who met in Belgium this week to discuss ways of making it easier for companies to access funding on this side of the...