Bio-Outsourcing

Merck forced to borrow half of CDC stockpiles of Gardasil to meet demand

30-Oct-2019 By Ben Hargreaves

Merck announces that it has reallocated Gardasil from the US CDC stockpiles, as a surge in demand sees revenues from the vaccine rise 26% year-on-year.

GE Healthcare sets up UK biotech R&D lab

24-Oct-2019 By Vassia Barba

GE Healthcare opens lab space to provide developers with access to protein and cell analysis technologies to encourage networking and partnering on R&D services.

Alvogen agrees biosimilar commercial deals in three major markets

23-Oct-2019 By Staff Reporter

Biosimilar developer agrees three different distribution partners in South Korea, Israel and Canada for biosimilar to Forteo.

Sartorius in $750m swoop for Danaher Life Science businesses

22-Oct-2019 By Ben Hargreaves

Sartorius is set to acquire three biopharma businesses from Danaher, once the latter company concludes its deal for GE Biopharma.

Mesoblast and Lonza agree commercial manufacture of allogeneic cell therapy

22-Oct-2019 By Ben Hargreaves

Lonza will manufacture mesoblast’s lead cell therapy ahead of a planned US market launch, which could occur next year.

BIA Separations adds to Cornerstone vector development program

16-Oct-2019 By Vassia Barba

An expansion to BIA Separations' Cornerstone set of processing services for viral vector development adds the use of kryptonase and CIMmultus chromatography device.

CureDuchenne backs immune-resistant AAV gene therapy platform

01-Oct-2019 By Vassia Barba

CureDuchenne invests in Evader, a gene therapy platform created by Chameleon, which bypasses the immune responses obstructing repeated dosing.

Early manufacturing life-saving for biologics developers, says CMO exec

23-Sep-2019 By Vassia Barba

‘Talk to your CDMO early’ is the advice BioConnection gives to developers of biopharmaceuticals, suggesting that they make a reservation to ensure availability.

BIA Separations launches purification technology for AAV production

17-Sep-2019 By Vassia Barba

BIA Separations introduces technology able to remove host-cell DNA and proteins from AAV products, aiming to accelerate clinical development of gene therapies.

Nordic Life Science Days

#NLSDays2019 came to an end, but innovation is only kicking off

13-Sep-2019 By Vassia Barba

The seventh #NLSDays event saw the latest trends in fields including ATMP, clinical evolution, and R&D technologies, find their audience in Scandinavia.

Mallinckrodt agrees to sell CDMO business for $250m

11-Sep-2019 By Ben Hargreaves

Amid opioid lawsuits, Mallinckrodt looks to slim down its overall business by agreeing the sale of BioVectra to HIG.

Lonza works with Celltrion to ensure supply of Remsima drug substance

10-Sep-2019 By Ben Hargreaves

Lonza’s facility in Singapore will provide Celltrion with the drug substance product to meet demand for the latter’s Remsima biosimilar in the European and US market.

Manufacturing market for viral vectors and plasmids set to boom

06-Sep-2019 By Ben Hargreaves

Already in 2019, there have been a number of deals to pick up vector and plasmid manufacturers, such acquisitions are a sign of a rapidly developing market, one report suggests.

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.

iBio and CC-Pharming to launch plant-based rituximab in China

03-Sep-2019 By Vassia Barba

iBio grants CC-Pharming exclusive license to commercialize rituximab in China, as well as a research license to bring its FastPharming technology to the country.

Innovate UK provides grant for cell therapy preservation hydrogel

03-Sep-2019 By Vassia Barba

Atelerix to work on the development of gel stabilisation technologies enabling room temperature storage of Rexgenero’s cell therapy candidate, under an Innovate UK grant.

Sterling begins large-scale silica production for Nanologica

29-Aug-2019 By Vassia Barba

Sterling begins manufacturing of $14m worth of silica particles as preparative chromatography media, after deal with Chinese distributor.

Chinese CDMO contracted to manufacture Pfizer’s oncology candidate

27-Aug-2019 By Vassia Barba

CMAB Biopharma to support Kintor in the clinical development of a potential treatment for liver cancer, ahead of regulatory filing.

Merck partners for ‘blockbuster’ vaccine target

26-Aug-2019 By Vassia Barba

Themis obtains an exclusive licence from Merck to develop vaccine candidates with an undisclosed indication, using its measles virus vector-based platform.

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.

Leo to market AstraZeneca’s psoriasis treatment outside the EU

15-Aug-2019 By Vassia Barba

Leo Pharma acquires exclusive rights to develop and market brodalumab, a treatment for psoriasis, outside of Europe.

Poll

Will the consolidation in biologics manufacture continue?

09-Aug-2019 By Ben Hargreaves

This year has seen some major trends across the industry, with a significant amount of deals seeing the biologics CDMO market consolidating.

EQT VIII Fund invests in Aldevron, supports capacity expansion

07-Aug-2019 By Vassia Barba

EQT VIII Fund set to acquire majority interest in plasmid DNA supplier Aldevron, announces investments to support the expansion of its production capacity.

Lonza to continue narsoplimab manufacture for Omeros

01-Aug-2019 By Vassia Barba

Lonza extends its deal with Omeros for the commercial manufacture of a treatment for thrombotic microangiopathy, ahead of filing with the US FDA and the EMA.

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.

Fill/finish services set to grow at annual rate of over 10%

26-Jul-2019 By Ben Hargreaves

Growing demand for biologic fill/finish services will see the market develop at a fast pace moving toward 2030, with a number of companies investing heavily in the area.

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.

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’.

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.

Working against the ‘hard’ vaccines with patient capital

08-Jul-2019 By Vassia Barba

Vaccine research is still quite ‘empirical’ and there is a long way until it is turned into a rational, predictable modality, suggests director at the Bill and Melinda Gates Foundation.

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.

Mundipharma expands its European footprint with Herceptin biosimilar

04-Jul-2019 By Vassia Barba

Mundipharma partners with Prestige to commercialize and supply a biosimilar to Roche’s Herceptin, for patients with breast, gastric and gastroesophageal cancer.

FDA should improve incentives to lower drug costs, says Dyadic CEO

02-Jul-2019 By Vassia Barba

The FDA needs to expedite the approval process to provide incentives for the development of more affordable drugs, says Dyadic CEO.

Amicus picks Brammer for preclinical, clinical gene therapy work

02-Jul-2019 By Vassia Barba

Rare disease drug developer to work with Brammer Bio – which Thermo Fisher acquired in March – on gene therapy programs against Batten disease.

Catalent bolsters Paragon through Novavax deal

02-Jul-2019 By Vassia Barba

Aiming to boost the gene therapy development and manufacturing capabilities of Paragon, which Catalent acquired in April, the CDMO has agreed to acquire all of the gene therapy-related assets from Novavax, a late-stage vaccine developer.

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.

iBio activates sterile fill-finish operations for clinical stage biopharma

27-Jun-2019 By Maggie Lynch

Sterile fill-finish capabilities will be available to clinical stage customers as iBio activates its operations for biopharmaceutical products after entering a supply agreement.

Emergent in $535m smallpox contract with US government

25-Jun-2019 By Vassia Barba

Emergent to supply a treatment for complications of smallpox vaccination to the Strategic National Stockpile, under $535m contract with the HHS.

Cell therapies reordering the CDMO market, says Thermo Fisher

25-Jun-2019 By Vassia Barba

Thermo Fisher has moved from ‘selling services’ to ‘selling solutions’, adapting to the demands of cell and gene therapies, executive says.

Be The Match and TrakCel partner on integrated services for cell therapy developers

24-Jun-2019 By Vassia Barba

Be The Match BioTherapies and TrakCel form a strategic partnership to integrate their offering for companies developing cell and gene therapies.

Fujifilm Diosynth COO on industry ‘buzz’ for cell therapies

24-Jun-2019 By Vassia Barba

Fujifilm Diosynth has developed its ability to transition products from research to GMP, answering a big challenge as more parties look to get involved in the space, says COO.

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.

‘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.

Bluebird chooses partner for manufacture of its first approved product

13-Jun-2019 By Ben Hargreaves

Apceth announces that it will be responsible for the commercial manufacture of Zyntelgo, after its approval last week.

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.

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.

PE firm Ampersand acquires German CDMO Vibalogics

03-Jun-2019 By Maggie Lynch

The private equity firm Ampersand Capital has acquired Vibalogics with plans to increase development and manufacturing capabilities for complex viral products.

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.

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