Facilities

Cook Pharmica teams with cell line development firm Selexis

27-Jun-2014 By Gareth Macdonald

Cook Pharmica and Selexis claim their combined service offering will help biopharmas scale up mAb and biosimilars production faster and more cheaply.

Govt-backed cell therapy centre will help UK firms reach market says CTC

25-Jun-2014 By Gareth Macdonald

A new cell therapy development centre has opened at Guy’s Hospital in London today in the latest stage of a Government-backed effort to establish the UK as a global hub.

GSK confident despite ongoing endotoxin problems at Canadian flu vaccine plant

25-Jun-2014 By Gareth Macdonald

GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.

Dispatches from BIO

Genzyme offers inside look at Massachusetts plant under consent decree

25-Jun-2014 By Zachary Brennan

More than four years after Genzyme was issued a consent decree by the FDA at its biomanufacturing facility in Allston, Massachusetts, and the company is still completing its remediation efforts and will be for the years to come.

Dispatches from BIO 2014

Kalon building $91m vaccine manufacturing facility in Texas for GSK partnership

24-Jun-2014 By Zachary Brennan

Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline.

Alexion gives NICE requested Soliris info ahead of July review

20-Jun-2014 By Gareth Macdonald

Alexion says it has provided NICE with the R&D and manufacturing information it asked for ahead of the second assessment of its £3,150-a-vial rare blood disorder drug Soliris next month.

Which came first the spaniel or the egg? Novartis' flu vaccine plant OKed

18-Jun-2014 By Gareth Macdonald

A long dead cocker spaniel will play a key role in helping people avoid the flu this winter after a landmark approval from the US FDA for Novartis’ cell culture based vaccine plant.

Protein Sciences lauds benefits of Pfizer refit in commercial scale-up

13-Jun-2014 By Dan Stanton

Small biotechs should consider buying mothballed plants when scaling-up according to Protein Sciences, which says an ex-Pfizer facility was key to accelerating production of its vaccine Flublok.

ADC pipelines drive single-use expansion at Lonza's clinical facility

11-Jun-2014 By Dan Stanton

Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.

Two more Roche biologics stolen, say Italian authorities

11-Jun-2014 By Fiona BARRY

Vials of two Roche biologics have been stolen and distributed illegally from Italy, say authorities.

Rentschler doubles capacity with new single-use bioreactor

10-Jun-2014 By Zachary Brennan

German CMO Rentschler Biotechnologie GmbH is adding a 2,000 L single-use bioreactor to its facility in Laupheim, Germany, which it expects to be fully operational by the end of the first quarter of 2015.

Pfizer, Merck and J&J discuss differing biosimilar strategies

06-Jun-2014 By Dan Stanton

Big biopharma biosimilar development strategies vary substantially with Pfizer, Merck and Janssen split on how best to approach the burgeoning market.

PharmaCell seeks more biomanufacturing contracts for new plant

06-Jun-2014 By Gareth Macdonald

European Provenge contractor PharmaCell BV is looking for new business after completing the acquisition of TiGenix’s biomanufacturing facility in the Netherlands.

Glenmark opens mAb manufacturing facility in Switzerland

06-Jun-2014 By Zachary Brennan

Glenmark Pharmaceuticals has opened a new cGMP-compliant monoclonal antibody (mAb) manufacturing facility in La Chaux-de-Fonds, Switzerland.

PacificGMP doubles production capacity with GE bioreactor

06-Jun-2014 By Zachary Brennan

CDMO (contract development and manufacturing organization) PacificGMP has doubled its GMP (good manufacturing practice) production capacity with the addition of a second System 1000 bioreactor platform from GE Healthcare.

Lack of skilled workers holding back India's biomanufacturing sector

04-Jun-2014 By Dan Stanton

Biomanufacturing in India is being held back by a lack of skilled workers but training initiatives are helping to address the problem, say Oncobiologics and Biocon.

Another Soliris recall as Alexion evaluates its manufacturing network

03-Jun-2014 By Dan Stanton

Alexion has recalled another nine lots of Soliris after finding "visible particles" in vials of the $600,000-a-year drug for the third time in 10 months.

Oncobiologics-Ipca JV will replicate US biosimilars plant in India

03-Jun-2014 By Dan Stanton

Oncobiologics will replicate its US biomanufacturing facility in India as part of a new biosimilars-focussed deal penned with drugmaker Ipca.

SAFC expands continuous flow capacity in Wisconsin

30-May-2014 By Zachary Brennan

SAFC, the custom manufacturing services business of Sigma-Aldrich, has installed a new commercial-scale continuous flow reactor at its Sheboygan, Wisconsin, facility with capacity to produce up to 150 kg of product per day.

Biopharma wary of disposable systems for large-scale production... for now

28-May-2014 By Dan Stanton

Janssen has mirrored Pfizer’s concerns about the scale, price and robustness of using single-use technology for high-volume production but says industry collaboration could help bring standards in place.

Inside NIBRT: Ireland’s 'flight simulator for biopharma manufacturing'

27-May-2014 By Dan Stanton

A government funded bioprocessing institute is helping to drive biopharma investment and retrain workers in Ireland, and Biopharma-Reporter.com visited to find out what happens in this "flight simulator for biopharma manufacturing."

Hemispherx signs with GP Pharm to manufacture Ampligen in Argentina

23-May-2014 By Zachary Brennan

Hemispherx Biopharma announced a preliminary stage agreement with GP Pharm to manufacture Ampligen in Argentina in order to serve Latin American markets pending approval.

Pfizer nabs Roslin Cells in cell therapy manufacturing deal

23-May-2014 By Zachary Brennan

Roslin Cells has signed a contract with Neusentis, a research unit of Pfizer based in Cambridge, UK, to support the manufacture of retinal pigment epithelium (RPE) cells to be used in a cell therapy clinical trial.

Merck to invest $68m in Italian biopharma production site

23-May-2014 By Zachary Brennan

As part of an effort to meet a rising demand for biopharmaceuticals, Germany-based Merck has agreed to invest about $68m (€50m) in its Italian production site in Bari.

Survey finds solid base for early phase cell therapy manufacturing in UK

20-May-2014 By Zachary Brennan

The UK manufacturing sector covers all of its bases in terms of the current cell therapy manufacturing requirements and includes “a strong manufacturing base” to bring early phase academic research into the clinic, according to a survey conducted by Cell...

Novasep invests $5.5m in ADC manufacturing tech at French plant

15-May-2014 By Zachary Brennan

Novasep has made a $5.5m (€4m) investment to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France.

KBI Biopharma acquires Merck’s biomanufacturing facility in Colorado

15-May-2014 By Zachary Brennan

KBI Biopharma has agreed to acquire Merck’s microbial process development and manufacturing operations in Boulder, Colorado.

DISPATCHES FROM THE BIOLOGICAL PRODUCTION FORUM, DUBLIN

Pfizer stays stainless saying single-use cost burdens high volume production

14-May-2014 By Dan Stanton

Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.

Texas biomanufacturing centre aims to up US medical countermeasures

09-May-2014 By Zachary Brennan

Armed with a $285m investment from the US Department of Health and Human Services – the largest of three investments -- the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM) is now using advanced manufacturing techniques...

UCB aims to halve antibody discovery time with robot

09-May-2014 By Fiona BARRY

UCB has launched a robot it says can halve antibody discovery time.

Biologic allergenic extract manufacturer hit with US FDA Warning Letter

07-May-2014 By Dan Stanton

Live insects observed during filling operations at a Greer Laboratories facility were one of a number of violations in the manufacture of its biological allergenic extracts cited in a US FDA warning letter.

'Milestone for Chinese Biologics' as WuXi wins mAb contract

07-May-2014 By Dan Stanton

In what it says “is a milestone for the Chinese Biologics industry,” WuXi PharmaTech beat off bids from Lonza and Boehringer Ingelheim to make a monoclonal antibody for TaiMed

Wuxi to equip new cell therapy plant with single-use systems

02-May-2014 By Zachary Brennan

WuXi PharmaTech says it has no intention using stainless steel tanks at its new cell therapy manufacturing facility in Philadelphia, Pennsylvania.

US FDA stings scorpion anti-venom biomanufacturer with Warning Letter

02-May-2014 By Dan Stanton

No shortage of an FDA approved scorpion anti-venom biopharmaceutical is envisioned after a manufacturing facility in Mexico received a Warning Letter, US distributor Rare Disease Therapeutics says.

Lonza: growth in mammalian services as ADC plant opening nears

29-Apr-2014 By Dan Stanton

Increased demand for mammalian technologies will boost Lonza further when a new Swiss facility comes online offering “unique” complete development and manufacturing ADC services, the firm says.

B-MS, Samsung extend biologics manufacturing agreement

25-Apr-2014 By Zachary Brennan

Bristol-Myers Squibb and Samsung Biologics have expanded their existing agreement in which Samsung will manufacture several unnamed biologics at its Incheon, South Korea manufacturing site. Financial terms of the agreement were not disclosed.

Sanofi sells therapy cells: Aastrom buys products and plants

22-Apr-2014 By Gareth Macdonald

Aastrom Biosciences will pay Sanofi $6.5m (EUR4.7m) for its cell therapy business in a deal that gives the cash strapped regenerative medicines developer three commercial products.

AbbVie inks Humira packaging deal as it launches in Saudi Arabia

22-Apr-2014 By Dan Stanton

AbbVie has teamed up with Arabio for the secondary packaging of its blockbuster biologic Humira as part of a launch into Saudi Arabian market.

Stem cell developer ReNeuron relocates to take on more manufacture

15-Apr-2014 By Fiona BARRY

Stem cell company ReNeuron will move its operations and headquarters to Cardiff, UK after leasing an R&D and manufacturing facility from the Welsh government.

US CBER 2013: new vaccines and draft guides for biologics trials

15-Apr-2014 By Gareth Macdonald

The US agency that oversees biologics approved eight vaccines for diseases ranging from influenza to Japanese encephalitis in 2013 according to a new report.

US CBER says relocation may delay review submissions but not lot tests

11-Apr-2014 By Gareth Macdonald

The US agency that oversees biopharmaceuticals will continue to assess lot release samples for approved productions but BLA review timelines may be impacted by its move to a new HQ in Maryland.

NW Bio raises $32m to expand capacity for personalised brain cancer treatment

11-Apr-2014 By Zachary Brennan

Northwest Biotherapeutics, which is developing personalized immune therapies for brain cancer patients, has raised $32m to fund expansion of its manufacturing operations in Europe.

Pfizer, Novartis developing MenB vaccines to combat new strain

09-Apr-2014 By Zachary Brennan

Recent outbreaks of a strain of meningitis, known as “serogroup B” or “MenB”, on US college campuses have caused both Pfizer and Novartis to develop new vaccines.

Kyowa Hakko Kirin completes $60m mammalian plant with 12,000L bioreactor

08-Apr-2014 By Dan Stanton

Kyowa Hakko Kirin has completed construction of a ¥6bn ($60m) biomanufacturing plant in Japan boasting a 12,000L stainless steel mammalian bioreactor.

Regulatory uncertainties hampering European advanced therapy sector, report

08-Apr-2014 By Zachary Brennan

Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...

Alexion announces third Irish facility

04-Apr-2014

Soliris manufacturer Alexion has announced its €75m ($103m) third Irish plant will create 200 new jobs.

Continuous chromatography tech part of 'facility of the future,' says Novasep

02-Apr-2014 By Dan Stanton

Novasep has reported a 14 percent growth in its biopharma business driven in part by demand for downstream manufacturing and its continuous chromatography systems.

Cobra's French mAb customers to get R&D tax credit

01-Apr-2014 By Gareth Macdonald

French mAb developers that hire Cobra Biologics stand to benefit from tax breaks after the French Ministry of Higher Education and Research (MESR) named the CMO as a preferred provider.

dispatches from interphex