Facilities

Q&A

UK cell and gene therapy ecosystem ‘second to none’

26-Nov-2018 By Ben Hargreaves

The UK has a ‘rich and vibrant’ advanced therapeutic manufacturing sector well placed to attract companies post-Brexit, says Keith Thompson, CEO of CGTC.

UK invests to streamline manufacture of next-gen medicine

23-Nov-2018 By Ben Hargreaves

Funding of £7.3m will be provided across three initiatives, with the long-term aim of providing patients with access to cell and gene therapies at a faster rate.

WuXi Biologics announces new discovery, development and manufacturing site in China

23-Nov-2018 By Flora Southey

The CDMO has broken ground on its 1.6 million-square-foot Biologics Innovation Center in Shanghai.

Rentschler opens GMP fill/finish facility in Austria

21-Nov-2018 By Staff Reporter

Aseptic fill/finish contractor Rentschler Fill Solutions inaugurated the new facility in Austria’s eastern town of Rankweil.

ADC Bio secures funding to further manufacturing plans

16-Nov-2018 By Ben Hargreaves

The company announced an investment of £2.5m to design its downstream formulation and filling operations.

NEWS IN BRIEF

WuXi Biologics breaks ground on $240m manufacturing site near Beijing

09-Nov-2018 By Flora Southey

Construction has started at WuXi Biologics’ eighth drug substance manufacturing facility, which CEO Chris Chen says will enable the CDMO to “develop and manufacture biologics more cost effectively”.

Coherus receives US FDA approval for Neulasta biosimilar, pricing 33% lower

09-Nov-2018 By Ben Hargreaves

The company will launch Udenyca onto the US market on January 3, 2019, to compete with Amgen’s originator product and Mylan’s rival biosimilar.

BIO Europe 2018

#BIOEurope: ‘Deal making is off the charts and the IPO window is open’

08-Nov-2018 By Flora Southey

Denmark played host to its first BIO Europe this week, welcoming 4,500 attendees from across the globe – including growing numbers from China and South Korea.

Astellas invests $256m in cell therapy manufacturing buildout

07-Nov-2018 By Ben Hargreaves

The company will construct two facilities in Japan and relocate its regenerative medicine facility in the US.

CAR-T manufacture ‘where mAbs were in the early 1990s’, says bluebird CTMO

05-Nov-2018 By Ben Hargreaves

With cell and gene therapies developing at a rapid pace, it leaves significant questions as to how manufacturing processes are keeping up.

Novo Nordisk cuts 3% of staff to ‘transform biological and technological innovation’

02-Nov-2018 By Ben Hargreaves

The Danish drugmaker announced that job losses at the company will number 1,300 before the end of the year, with the majority of those already having left their roles.

Lonza invests in ‘game-changer’ automated cell therapy manufacture

31-Oct-2018 By Ben Hargreaves

After a three-year partnership, Lonza pulled the trigger on acquiring a controlling stake of Octane Biotech and their jointly developed Cocoon system.

Johnson & Johnson boost vaccine production at Dutch facility

30-Oct-2018 By Maggie Lynch

Johnson & Johnson has unveiled a vaccine facility in Leiden, the Netherlands, which will focus on R&D, technological development, and large-scale production of vaccines for late-stage clinical trials.

Shire requests US approval to make Flexbumin at plasma plant

26-Oct-2018 By Flora Southey

Shire has filed a US FDA submission to manufacture plasma-volume replacement therapy, Flexbumin, at its new plant in Stanton Springs, Georgia.

Avid expansion to triple process development capacity, says CEO

25-Oct-2018 By Ben Hargreaves

Avid continues its transition to a fully-fledged CDMO by transforming its process development capabilities with new lab space.

Shire opens $1.2bn, six-years-in-the-making facility

23-Oct-2018 By Ben Hargreaves

Shire’s immune globulin infusion-producing facility will increase the company plasma manufacturing capacity by one third.

BIA Bioscience Forum

Four major barriers to efficient cell & gene manufacture

22-Oct-2018 By Ben Hargreaves

BIA’s Bioscience Forum brought together four experts on cell and gene manufacture to discuss what difficulties are being faced in the industry and how they are reacting to them.

Berkeley Lights looks to CAR-T manufacture after securing $95m investment

19-Oct-2018 By Ben Hargreaves

This week Berkeley announced it had tied up a financing round and signed a cell line development deal with Selexis.

The rise of bio-education: Pall Biotech inks latest training centre deal

18-Oct-2018 By Flora Southey

The UCL-Pall Biotech Centre of Excellence is the most recent workforce development programme to launch in the fast-growing bioprocess training space.

MSD adds vaccine and biologics facility next to Keytruda site, creates 170 jobs

17-Oct-2018 By Flora Southey

MSD will build a second manufacturing plant in County Carlow, Ireland, in response to growing demand.

Lonza expands manufacturing sites for larger ADC payloads

16-Oct-2018 By Maggie Lynch

Lonza Pharma & Biotech will expand two of its manufacturing sites to reach the capabilities necessary to produce compounds bio-conjugates through to commercialization.

CBMG inks Kymriah deal: ‘China could take the lead in cell therapies’

15-Oct-2018 By Ben Hargreaves

CBMG announced a manufacturing collaboration agreement with Novartis at the end of last month to produce CAR-T treatment Kymriah for the Chinese market and the company has further ambitions in the pipeline.

CPhI Worldwide 2018

Samsung BioLogics opens third plant, contemplates a fourth in Korea

12-Oct-2018 By Flora Southey

The CDMO’s third biomanufacturing plant, regarded the world’s largest, is now operational in South Korea.

Mammalian plant a convenient option for growing Asian client base, says AGC

12-Oct-2018 By Flora Southey

AGC Biologics has announced plans to build a mammalian cell culture facility in Japan, where the company says demand is growing for antibody-based therapies.

Bayer cuts 227 jobs at Jivi plant in California

05-Oct-2018 By Flora Southey

Having now secured regulatory approval for all three of its haemophilia A therapies made in Berkeley, Bayer is implementing “organisational changes” across the facility.

Novo Nordisk sets up stem cell manufacturing in California, US

02-Oct-2018 By Flora Southey

Novo Nordisk will take over the lease of a manufacturing facility in Fremont, California, where the company will make stem cell-based therapies with optionally licensed technology.

Purolite opens 100,000L agarose plant in Wales

28-Sep-2018 By Flora Southey

Purolite Life Sciences’ new agarose manufacturing plant will supply chromatography resins up to 70% cheaper than GE’s offerings, says executive.

G-CON selects Pall’s continuous bioprocessing and viral vector tech

28-Sep-2018 By Flora Southey

G-CON Manufacturing has partnered with Pall Corporation to offer prefabricated cleanrooms for continuous bioprocessing and viral vector production.

NEWS IN BRIEF

BIA Separations adds upstream processing facility

28-Sep-2018 By Ben Hargreaves

BIA Separations has completed work on an additional upstream processing laboratory in Ajdovščina, Slovenia.

Inside the Testa Bioprocess Innovation Center

26-Sep-2018 By Flora Southey

Biopharma-Reporter takes you inside the recently opened Testa BioProcess Innovation Center in Uppsala, Sweden, and speaks with CEO of GE Nordics, Lotta Ljungqvist.

BeiGene adopts GE ‘turnkey’ factory for anti-PD-1 mAb production

25-Sep-2018 By Flora Southey

BeiGene will use GE Healthcare Life Sciences’ ‘off-the-shelf’ factory to manufacture monoclonal antibodies in Guangdong Province, China.

Lonza invests $418m in two biomanufacturing solutions

21-Sep-2018 By Ben Hargreaves

Lonza announced it would invest in two new “Ibex Solutions”, which offer manufacturing capabilities to biotechs developing antibody therapies.

TriLink BioTechnologies to relocate to expand operations

21-Sep-2018 By Maggie Lynch

TriLink BioTechnologies, a subsidiary of Maravai, that provides gene therapy services to researchers, has announced it will relocate to expand the company’s operations.

Novo Nordisk creates four R&D centres by shedding 400 jobs

19-Sep-2018 By Ben Hargreaves

Novo Nordisk will restructure its R&D operations through the increased investment made possible by laying off 400 members of staff.

US FDA eases Teva headache with Ajovy approval

18-Sep-2018 By Flora Southey

Regulatory setbacks at Teva’s CMO facility in Korea have not halted the regulatory progression of preventive migraine treatment Ajovy, which has received US FDA approval.

BAYER UPDATE

Pfizer, Merck and Novartis to shut manufacturing sites as hurricane looms

13-Sep-2018 By Maggie Lynch & Flora Southey

Major pharmaceutical companies and CMOs in the US have announced emergency contingency plans, including facility closures and the relocation of drug products, as Hurricane Florence approaches southeastern shores.

Softbox launches service to improve biopharma eco-sustainability

05-Sep-2018 By Maggie Lynch

Softbox launched its Green Recycling Service as an eco-friendly way to provide recycling options for cold-chain technology packaging components.

BiondVax expands manufacturing capabilities for universal flu vaccine

04-Sep-2018 By Ben Hargreaves

BiondVax moved into a new facility with an increased capacity of 40 million doses per year ahead of potential approval for its universal flu vaccine.

MHRA and EMA divorce process continues ahead of Brexit deadline

04-Sep-2018 By Ben Hargreaves

It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.

Q&A

Testa Center will help GE better serve bioprocessing industry, says CEO

03-Sep-2018 By Flora Southey

GE Nordics CEO Lotta Ljungqvist says the recently opened Testa Center will help facilitate innovation in the biopharmaceutical space.

Novartis further invests in cell and gene therapy manufacture, after Kymriah approval

29-Aug-2018 By Ben Hargreaves

Novartis plans to step up its capabilities of manufacturing cell and gene therapies with a new facility to be built in Stein, Switzerland.

ABEC to supply China’s ‘rapidly growing’ biopharma industry from Ireland

28-Aug-2018 By Flora Southey

China has accredited ABEC to make and supply bioprocessing equipment from its Kells facility in Ireland.

WuXi Biologics says bispecific platform could ‘transform the industry’

24-Aug-2018 By Flora Southey

The Chinese CDMO announced plans to launch its bispecific platform, ‘WuXiBody’, in its half-yearly report, which records “phenomenal” revenue growth.

GE Healthcare opens bioprocessing ‘test bed’ for biotechs

21-Aug-2018 By Flora Southey

The Testa BioProcess Innovation Center in Sweden will help academics, startups, and biopharmaceutical companies secure industrial proof-of-concepts quicker, and with less cost, says GE Healthcare.

Samsung looks to expand CDMO biz with $22bn investment

17-Aug-2018 By Flora Southey

Samsung plans to invest KRW 180 trillion into its various businesses over the next three years, including in biomanufacturing-focused Samsung BioLogics.

Amgen begins work on $200m ‘next-gen’ biomanufacturing site

10-Aug-2018 By Ben Hargreaves

Amgen has broken ground on the construction of its West Greenwich, Rhode Island-based 120,000-square-foot biomanufacturing facility.

UPDATED

Celltrion hit with Form 483 over troublesome Incheon plant

08-Aug-2018 By Ben Hargreaves

Celltrion has told shareholders its manufacturing site received a Form 483 from the US FDA.

Grifols acquires Biotest US in $286m deal

08-Aug-2018 By Maggie Lynch

Grifols acquires the entirety of Biotest US for $286m, a deal which includes a number of plasma collection facilities and corporate offices.

Rubius to pay $8m for ex-Soliris plant with troubled past

27-Jul-2018 By Flora Southey

Rubius has announced plans to acquire Alexion’s manufacturing facility in Rhode Island, where the latter made immunosuppressant Soliris before exiting the site last year.

WuXi Biologics’ third site: First batch done, US client next

26-Jul-2018 By Flora Southey

WuXi Biologics completed its first manufacturing project at its 200,000 sq. ft. facility in Wuxi City earlier this week.