Facilities

Pall inks $7m deal with Exothera for suspension based production of viral vectors

19-Jul-2021 By Jane Byrne

Filtration, separation and purification specialist, Pall, has announced a new contract valued at over US$7M with full-service CDMO, Exothera.

GentiBio and Forge Biologics in viral vector contract development and GMP manufacturing partnership

19-Jul-2021 By Jane Byrne

Boston headquartered biotherapeutics company, GentiBio, Inc, and CGT focused CDMO, Forge Biologics, have set up a development and manufacturing partnership.

Ardena ploughs €35m into sites to future proof CDMO services

15-Jul-2021 By Jane Byrne

Ardena is investing €35m (US$41.3m) in expansion projects across its European operations.

Chinese COVID-19 vaccine makers in supply deal with COVAX

13-Jul-2021 By Jane Byrne

Gavi, which manages COVAX, the global COVID-19 vaccine sharing scheme, says it has secured much-needed vaccines from Chinese producers, Sinovac and Sinopharm.

Univercells Technologies in tie-up with Chinese player on viral vectors for CGT and vaccine sectors

12-Jul-2021 By Jane Byrne

Belgium’s Univercells Technologies and China’s VectorBuilder have entered a strategic global partnership for custom viral vector production.

Fujifilm continues to expand its biologics CDMO business, ploughing further $850m into US and UK sites

08-Jul-2021 By Jane Byrne

Fujifilm Corporation has made an additional US$850m investment to enable the expansion of its BIO-CMDO sites in the UK, at Billingham, and in the US.

Viralgen expands AAV vector manufacturing in Spain

05-Jul-2021 By Jane Byrne

Bayer owned CDMO, Viralgen, has expanded its AAV vector manufacturing capabilities in San Sebastian, in the Basque region of Spain, with the opening last week of a new site.

EMA backs active substance scale-up at Janssen’s COVID-19 vaccine site in the Netherlands

05-Jul-2021 By Jane Byrne

The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.

Sanofi commits to €400m annual investment in mRNA vaccines

01-Jul-2021 By Ben Hargreaves

After the success of COVID-19 mRNA vaccines, the company takes the decision as part of a ‘long-term play’ to target diseases beyond the pandemic.

Amgen in $365m ‘smart facility’ manufacturing expansion

01-Jul-2021 By Ben Hargreaves

The biotech invests in a new facility that will assemble and package vials and syringes for its portfolio of products.

EMA approves additional J&J vaccine manufacturing site

29-Jun-2021 By Ben Hargreaves

The agency allows fill-finish activities for Janssen’s COVID-19 vaccine to take place at Catalent’s Italian site.

Legend Biotech and Janssen establish Belgium cell therapy site

28-Jun-2021 By Ben Hargreaves

The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.

Genezen breaks ground on cGMP lentiviral vector production facility

28-Jun-2021 By Jane Byrne

Genezen Laboratories, Inc, a US cell and gene therapy contract development and manufacturing Organization (CDMO) is set to build a 75,000+ square foot cGMP-compliant lentiviral vector production facility in Indianapolis.

Dendreon makes leap to become cell therapy CMO

25-Jun-2021 By Ben Hargreaves

Dendreon pivots to become a contract manufacturer of late-stage cell therapies, centered on its Seal Beach facility.

Acquisition of German player gives Catalent enhanced iPSC-based cell therapy capabilities

25-Jun-2021 By Jane Byrne

Catalent is to acquire German company, RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies.

Moderna adds 155 jobs as it doubles vaccine production capacity

23-Jun-2021 By Ben Hargreaves

The company states that it will hire at least 155 new employees into manufacturing positions during 2021.

Coriolis expands ATMP facilities to advance formulation

22-Jun-2021 By Ben Hargreaves

Coriolis Pharma has announced a 7,800-meter-square expansion to a building situated in Munich, Germany, where the company is headquartered, that will host formulation development for advanced therapeutic medicine products (ATMPs).

Biogen on aducanumab: ‘We’re ready for an immediate launch’

09-Jun-2021 By Rachel Arthur

Biogen expects to begin shipping Aduhelm (aducanumab-avwa) in two weeks: after the FDA granted the Alzheimer's drug accelerated approval on Monday.

US Dept of Justice officials subpoena documents as part of probe into Lilly’s New Jersey plant

31-May-2021 By Jane Byrne

Eli Lilly and Co received a subpoena late last week from the US Department of Justice (DOJ), requesting certain documents, as part of a probe into its manufacturing site in Branchburg, New Jersey.

Samsung Biologics to provide end-to-end mRNA vaccine manufacturing

31-May-2021 By Rachel Arthur

Samsung Biologics will add mRNA vaccine drug substance production capability to its facility in South Korea, aiming to provide end-to-end mRNA vaccine manufacturing services.

Merck rolls out new lipid technology nine months ahead of schedule

27-May-2021 By Jane Byrne

Germany’s Merck KGaA has launched a new synthetic cholesterol product that it says will boost capacity for its lipid delivery tools by 50 times.

UPS: ‘The market for drugs and therapies requiring cold storage is growing at a rapid rate’

27-May-2021 By Jane Byrne

UPS Healthcare says it has invested in its suite of cold chain technologies on the back of ‘unreal growth’ in the pharmaceutical cold chain market.

Thermo Fisher and University of California look to cut costs and speed up adoption of cell therapies

20-May-2021 By Jane Byrne

Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.

New BD plant set for Spain aims to meet growing demand for PFS

20-May-2021 By Jane Byrne

Becton, Dickinson and Company (BD) is to build a new plant in Zaragoza, Spain, with an investment of €165m (US$200m). The site will produce glass pre-filled syringes and plastic components.

Protalix to propose virtual inspection to clear barrier to FDA approval

20-May-2021 By Nick Taylor

Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.

Acquisition boosts Charles River's viral vector, AAV and plasmid DNA production expertise

18-May-2021 By Jane Byrne

Charles River Laboratories International Inc is to acquire US based Vigene Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions for research and clinical...

Chicago emerging as a life science and biopharma hub

17-May-2021 By Jane Byrne

Many turn to Boston and North Carolina’s Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth,...

Novasep expands in France, sees increasing customer demand for ADC manufacturing services

14-May-2021 By Jane Byrne

Novasep has announced a further expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities at its Le Mans, France site, saying the move strengthens its position as a leading CDMO for the production of innovative...

'Connectivity is a key enabler for continuous manufacturing'

12-May-2021 By Jane Byrne

Connectivity of unit operations is a key enabler for continuous manufacturing to deliver benefits of not only improved mass throughput, but ultimately reduced COGS and increased facility utilization, says Merck.

Evotec turns to automation and continuous bioprocessing with new facility in France

12-May-2021 By Rachel Arthur

Evotec will build a biologics manufacturing facility in Toulouse, France: marking the company’s first commercial biomanufacturing facility in Europe.

BioNTech to build mRNA manufacturing facility in Singapore

10-May-2021 By Rachel Arthur

BioNTech plans to expand its global footprint with a regional headquarters for South East Asia in Singapore; as well as a fully integrated mRNA manufacturing facility.

Lonza leverages learnings from earlier ramp-up of Moderna drug substance, looks to boost staffing levels

04-May-2021 By Jane Byrne

A new agreement with Moderna will see Lonza add three more production lines at its site in Visp, Switzerland.

COVID-19: Meissner secures $13.4m BARDA award to produce single-use systems

03-May-2021 By Jane Byrne

Meissner Filtration Products has just been awarded a US$13.4m contract from the US government agency, BARDA, to boost its production capability for components critical to vaccines and therapies linked to the COVID-19 response.

Moderna ramps up COVID-19 vaccine supply to 3 billion doses in 2022

29-Apr-2021 By Rachel Arthur

Moderna has announced a set of additional investments to allow it to increase global supply of its COVID-19 vaccine. ‘We believe there will continue to be significant need for our vaccine into 2022 and 2023’, says the company.

Catalent looks to meet needs of expanding CGT market, completes expansion work at biologics drug substance facility

27-Apr-2021 By Jane Byrne

Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinical supply services facility in Philadelphia, in the US, to further support biotech firms developing cell and gene therapies.

Samsung Biologics and TG Therapeutics expand blood cancer partnership

27-Apr-2021 By Jane Byrne

US biopharma firm, TG Therapeutics, has announced an expanded contract manufacturing deal with Samsung Biologics to support the production of its investigational anti-CD20 monoclonal antibody, ublituximab.

Bristol Myers Squibb to build new cell therapy manufacturing site in the Netherlands

22-Apr-2021 By Rachel Arthur

Bristol Myers Squibb (BMS) will build a new cell therapy manufacturing site in Leiden, the Netherlands: marking the company’s first cell therapy manufacturing facility in Europe and its fifth globally.

Abzena choses North Carolina for new $200m biologics manufacturing site

15-Apr-2021 By Rachel Arthur

Global Partner Research Organization Abzena will build a new GMP manufacturing facility in Sanford, North Carolina.

EU gives BioNTech, AstraZeneca and Moderna green light for new COVID-19 production facilities

29-Mar-2021 By Rachel Arthur

The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...

First look inside BioNTech's Marburg site as it starts production for COVID-19 vaccine

10-Feb-2021 By Rachel Arthur

BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.

Orgenesis CEO talks disruption: ‘We are the Uber of the cell and gene therapy space’

17-Nov-2020 By Jane Byrne

The future of treatment for many of the most challenging diseases in the world is said to reside in personalized cell and gene therapy (CGT). These expensive and complex therapies have proven highly effective in multiple cases, but a challenge remains...

Fujifilm expands its gene therapy drug CDMO business

07-Oct-2020 By Jane Byrne

Fujifilm is boosting its gene therapy offering, taking the first steps to expand its viral vector contract development and manufacturing organization (CDMO) services to Europe, at the site of Fujifilm Diosynth Biotechnologies (FDB) in the North East of...

COVID-19 vaccine manufacturing centre gains MHRA approval; ready to produce tens of millions of doses in the UK

06-Oct-2020 By Rachel Arthur

The UK’s Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's...

CPhI Festival of Pharma

CPhl event to draw attention to M&A activity in gene and cell sector

01-Oct-2020 By Jane Byrne

The recent M&A trend in the cell and gene therapy space will be put under the spotlight at the CPhl Festival of Pharma.

‘Viral vector production demand will ultimately exceed the current global capacity’

23-Sep-2020 By Jane Byrne

Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.

BioPharma-Reporter

Resources