Facilities

FDA warns of ‘unnecessary risk’ as AmEx pulls lots of Avastin over sterility concerns

03-Sep-2019 By Ben Hargreaves

The US FDA has followed up a public recall request to AmEx by hosting the manufacturer’s notice of a voluntary recall of Avastin, after sterility concerns.

Samsung BioLogics’ perfusion technology to ‘reduce production time by up to 30%’

03-Sep-2019 By Ben Hargreaves

Samsung BioLogics announces adoption of perfusion technology with alternating tangential flow for the commercial bioproduction process.

Massachusetts bioproduction employment outpaces national average

03-Sep-2019 By Ben Hargreaves

Biopharma employment levels in the state of have Massachusetts grown at a rate of 6% since 2009, bettering the national average of 1%.

UPDATED

Biocon insulin facility in Malaysia passes EU inspection

27-Aug-2019 By Vassia Barba

Asia’s largest integrated insulins facility, operated by a subsidiary of Biocon in Malaysia, receives GMP compliance certification from Ireland’s HPRA.

Vaccine investment breathing new life into space?

23-Aug-2019 By Ben Hargreaves

Once a neglected area of pharma research, companies are now investing heavily after several major commercial successes and with promising new avenues of research progressing.

UPDATED

Pfizer puts $500m into gene therapy, expands manufacturing facility

22-Aug-2019 By Vassia Barba

Pfizer invests half a billion dollars to expand its gene therapy manufacturing facility in North Carolina and enhance its position to compete in the booming market.

WuXi Biologics posts global growth despite ‘geopolitical uncertainties’

21-Aug-2019 By Ben Hargreaves

In 1H financials, WuXi Biologics outlines positive developments across its ‘three major markets’, stressing that US growth is still strong despite US-China trade relations.

Fujifilm aims to become a ‘total healthcare company’, acquires Biogen facility

07-Aug-2019 By Maggie Lynch

Fujifilm completed the acquisition of Biogen manufacturing site in Denmark for $890m in a cash transaction as it works to expand its global business lines.

Celltrion sets up Chinese JV and eyes manufacturing facility in country

30-Jul-2019 By Ben Hargreaves

Celltrion has partnered with Nan Fung Group to create Vcell Healthcare, which will manufacture and commercialize three of Celltrion’s biosimilar products in China.

July roundup sees flurry of partnership deals

29-Jul-2019 By Ben Hargreaves

The summer months are traditionally slow on movements across the industry, but July saw a number of manufacturing partnership deals take place as companies look ahead to product commercialization.

Lonza readies for ‘new wave of ADC therapies’ with Visp expansion

25-Jul-2019 By Ben Hargreaves

Lonza already manufacturers three out of five commercially available ADCs but is preparing for additional demand with a two-year expansion project at its Visp site.

Bioscience incubator to be built in Illinois to support growing Midwest hub

25-Jul-2019 By Maggie Lynch

Rosalind Franklin University of Medicine and Science opens its incubator, Helix 51, creating wet lab and research space for the Illinois bioscience hub.

UK cell and gene manufacturing employment increases by 30%

19-Jul-2019 By Ben Hargreaves

CGT Catapult reports that employment has increased substantially, and production capacity has grown by 60% in the UK cell and gene therapy manufacturing industry.

WHP completes ADC Bio’s £5m cleanroom in UK site

18-Jul-2019 By Vassia Barba

WHP completes the building of a cleanroom facility at a site expected to deliver ‘the next generation of anticancer blockbuster ADC drugs’.

Kite builds own viral vector supply through facility construction

17-Jul-2019 By Ben Hargreaves

Kite will bolster its supply of vectors by adding a facility to its existing site in California to be used in cell therapy production.

Paragon’s Maryland facility adds Passage Bio’s manufacturing suite

11-Jul-2019 By Maggie Lynch

Paragon and Passage Bio enter a collaboration agreement to develop a dedicated manufacturing suite at the former’s Maryland facility, as the latter’s gene therapy candidates enter the clinic.

Grifols expands in Africa with manufacturing facility

11-Jul-2019 By Vassia Barba

Grifols builds its first plant in Northern Africa for Morocco-based Soludia Maghreb, which will be used in the production of intravenous solutions bags.

BioNTech aims to advance pipeline to the clinic with $325m investment

10-Jul-2019 By Maggie Lynch

BioNTech completed a $325m Series B financing rounds as the biotech looks to advance its therapeutics pipeline and manufacturing capabilities.

FDA issues Biocon Form 483 with 12 observations

09-Jul-2019 By Vassia Barba

Following a pre-approval inspection of Biocon’s facilities in Malaysia, the US FDA issues 12 observations through a Form 483.

Novel manufacturing technologies ‘fit poorly’ into regulatory models, says EMA

05-Jul-2019 By Ben Hargreaves

The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.

Five deals reshaping the CDMO industry this year

05-Jul-2019 By Ben Hargreaves

The major trend so far in 2019 is the willingness to deploy capital to expand services in the cell and gene therapy sector, and we outline the five most significant deals thus far.

Fujifilm plots third cell culture facility in Netherlands

02-Jul-2019 By Ben Hargreaves

Fujifilm announces plans to open its third manufacturing facility for cell culture media, joining existing facilities in the US and Japan.

Q&A

Biotech manufacturing is Ireland’s ‘sweet spot’, IDA says

01-Jul-2019 By Vassia Barba

Ireland’s economy rises to the challenges of turnkey biotechnology areas, such as cell and gene therapies, during Brexit turmoil.

Viral vector manufacturing collaboration generates ‘tangible value’

27-Jun-2019 By Vassia Barba & Maggie Lynch

Cobra and Symbiosis announce the completion of their collaboration on viral vector development and manufacturing, supported by £1.9m Innovate UK grant.

WuXi Biologics adds ADC commercial manufacturing at WuXi city facility

25-Jun-2019 By Maggie Lynch

WuXi Biologics expands its biologics conjugation solution center to include space for commercial manufacturing of antibody-drug conjugates for the biopharma industry.

Gamida eyes cell therapy regulatory nod with Lonza partnership

20-Jun-2019 By Ben Hargreaves

Gamida continues its manufacturing agreement with Lonza for the future commercial production of its cell therapy, omidubicel.

UPDATED

Catalent continues expansion spree with BMS manufacturing facility

19-Jun-2019 By Ben Hargreaves

Catalent to purchase BMS’s Italian manufacturing facility to gain access to fill/finish capabilities, following several large-scale deals this year.

Discovery Labs opens $500m coworking space in Pennsylvania

19-Jun-2019 By Vassia Barba

Discovery Labs redevelops former GSK facility in King of Prussia, Pennsylvania, into a coworking area available for leasing by healthcare companies.

Cognizant acquires Zenith to become single source provider

18-Jun-2019 By Maggie Lynch

Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.

‘Business as usual’ for GE Healthcare ahead of Danaher acquisition

17-Jun-2019 By Ben Hargreaves

‘We don’t want to change the way we work,’ says GE Healthcare Life Sciences CEO, as Danaher’s $21bn acquisition of the BioPharma business continues in the background.

GSK backs up genomics refocus with UCB partnership

13-Jun-2019 By Ben Hargreaves

GSK signs partnership deal with the University of California to advance genomic research, which sees the creation of a lab and funding for five years of research.

CAR-Ts that grow on trees: Automating cell therapy manufacturing

11-Jun-2019 By Vassia Barba

As the cell and gene therapies market evolves, CDMOs and pharmaceutical companies aim to adapt to the rising demands and serve larger patient populations.

Fujifilm in $10m investment for continuous bioprocessing facility

11-Jun-2019 By Ben Hargreaves

Utilising single-use flow paths, Fujifilm will create a continuous bioprocessing manufacturing facility after three years of in-house development.

WuXi ploughs ahead with ‘world’s largest’ single-use facility

11-Jun-2019 By Ben Hargreaves

WuXi Biologics has selected its construction partner, Jacobs, for the building stage of its ‘Factory of the Future’ facility in Dundalk, Ireland.

Single-use tech ‘reshaping’ the industry as Thermo Fisher further invests

11-Jun-2019 By Maggie Lynch

Thermo Fisher invests into bioproduction capabilities as ‘single use continues to reshape the face of the industry,’ says single-use technology executive.

Aldevron ‘robust’ expansion ups biologics capacity by 10x and triples workforce

06-Jun-2019 By Ben Hargreaves

Aldevron announces the expansion of its headquarters’ campus by half a million-square-feet, which will see annual capacity exceed $1bn of biologic products.

Centrifuge to enable scalability launched through Thermo Fisher partnership

05-Jun-2019 By Maggie Lynch

Thermo Fisher and Scinogy partner to improve scalability and cost-effectiveness of cell and gene therapy manufacture through the addition of the former’s centrifuge.

How to solve the cell and gene therapy skill gap?

03-Jun-2019 By Ben Hargreaves

In the UK alone, the numbers of employees entering the cell and gene therapy manufacturing space needs to double in the next five years, eXmoor’s MD suggested.

GSK’s shingles vaccine approved in China

29-May-2019 By Maggie Lynch

GSK is investing in ‘significant’ capacity expansion to support production of its shingles vaccine, which has been approved in China after clinical trials demonstrated 90% efficacy.

Evotec jumps into biologics through $90m Just.Bio acquisition

29-May-2019 By Vassia Barba

Evotec to join the emerging biologics market through Just Biotherapeutics’ smart technology platforms, machine learning tools and low cost manufacturing facilities.

Cryoport expands into biostorage with Cryogene acquisition

23-May-2019 By Vassia Barba

Cryoport acquires Cryogene to gain access to the latter company’s 21,000-square-foot biostorage facility in Houston.

WuXi in $3bn deal to manufacture 'first of its kind' vaccine

23-May-2019 By Vassia Barba

WuXi Vaccines will build a dedicated manufacturing facility for an unnamed global vaccine leader, under a 20-year contract.

US Senate authorises increased spending on pandemic flu products

23-May-2019 By Nick Taylor

The Senate has passed a bill authorising spending on the development of products to protect the US against pandemic influenza and other biological threats to public health.

Dendreon extends lease on cell therapy plant to 2030

21-May-2019 By Nick Taylor

Dendreon Pharmaceuticals has extended the lease on its immunotherapy manufacturing facility in California through to 2030.

Celltrion plots $33.6bn investment and 1m litre production capacity expansion

20-May-2019 By Ben Hargreaves

Celltrion plans to invest across its pharmaceutical business up to 2030, creating an estimated 110,000 new jobs in the process and launching 20 products.

WuXi Biologics to build 1.3m-sq-ft manufacturing centre

16-May-2019 By Ben Hargreaves

WuXi Biologics announces its latest expansion, with plans for a drug development and commercial manufacturing site with a potential bioreactor capacity of 144,000L.

Bayer invests $150m to expand its biologics development

14-May-2019 By Ben Hargreaves

Bayer will build a 40,000-square-foot cell culture facility to bolster its capacity to develop therapies primarily focused on oncology and cardiology.

Report reveals US manufacturing centres outside traditional hubs

13-May-2019 By Ben Hargreaves

A PhRMA report outlined the benefits that are brought to the US economy by the biopharmaceutical manufacturing industry, including revealing where the majority of facilities are located.

Allergan creates 63 jobs with biologics manufacturing expansion in Ireland

30-Apr-2019 By Ben Hargreaves

Allergan will expand its existing facilities in Ireland through an investment of €65m to produce new product formats for existing and investigational products.

Maryland facility gives Kite room to grow in CAR-T

30-Apr-2019 By Maggie Lynch

Kite adds a facility in Maryland to expand manufacturing capabilities of its CAR-T therapies, including Yescarta.