Facilities & Capacity

Cell & gene CDMOs: Expansions by AGC, Celonic, Resilience

AGC Biologics plans to expand its cell and gene therapy center; Celonic has a new production site and Resilience acquires a manufacturing facility in Canada. Great to have you here for BioProcess Insider’s CDMO round-up. First up in our cell and gene contract development manufacturing organization (CDMO) round-up is AGC biologics which recently announced plans to expand its cell and gene therapy center located in Milan, Italy. The expansion will up its capacity and install viral vector suspension capabilities. The firm acquired Molecular…

Biogen to build $200m NC plant to support gene therapy ambitions

Biogen has laid down plans to build a gene therapy manufacturing at its Research Triangle Park (RTP) manufacturing campus in North Carolina. The planned 175,000 square-foot plant – set to create 90 jobs once operational – will support Biogen’s gene therapy pipeline across multiple therapeutic areas. “With this new facility, Biogen is investing in robust and scalable gene therapy manufacturing with the goal of ensuring reliable supply to patients worldwide,” the company said in a statement. “Gene therapy is an…

Rivals unite: J&J inks vaccine deal with Merck

Merck & Co. has partnered with J&J to help manufacture its single-shot COVID-19 vaccine which recently received approval from the FDA. After discontinuing its own COVID vaccine development at the start of this year, Merck & Co. (known as MSD outside of North America) has formed a partnership with Johnson & Johnson (J&J) to use its facilities to manufacture the vaccine and provide a fill-finish service. “Two of the largest pharmaceutical companies in the world who are usually competitors are…

Pharmaron to buy Allergan Biologics biz from AbbVie for $119m

The addition of a plant in Liverpool, UK, from AbbVie will support ambitions in the biologics and cell and gene therapy space, says service firm Pharmaron. Chinese pharma services firm Pharmaron Beijing Co is set to pay $118.7 million in cash to AbbVie for its Allergan Biologics Limited (ABL) business, located in Liverpool, UK. AbbVie acquired ABL as part of its $63 billion acquisition of Allergan in 2019. The proposed sale – expected to go through in the second quarter…

Catalent dismisses production problems in J&J COVID vaccine rollout

CDMO Catalent has refuted claims that US rollout of the recently approved J&J vaccine has been slowed down by problems at its fill-finish facilities. Shortly after the US Food and Drug Administration (FDA) approved Johnson & Johnson’s single-shot  vaccine making it the third authorized COVID vaccine  in the US, the Financial Times reported that Catalent is suffering production problems that “have contributed to the US government being set to receive millions fewer doses than it expected this month.” The British…

MilliporeSigma to manufacture biologics for Alteogen

South Korean firm Alteogen has partnered with CDMO MilliporeSigma to develop and produce biotherapeutics and monoclonal antibody drugs. The collaboration will see MilliporeSigma (the life sciences business of Germany’s Merck KGaA) provide Alteogen with late-stage manufacturing services which includes developing and producing recombinant biologics for clinical evaluation. “This agreement supports large-volume subcutaneous administration of biologics that would otherwise be administered as an IV infusion,” said head of Process Solutions at Merck, Andrew Bulpin. “This advances Merck’s strategy of providing breakthrough,…

Avid kicks off second phase of $60-70m capacity expansion

After beginning a $15 million expansion of its Myford, California facility late last year, CDMO Avid Bioservices is starting work on a second extension estimated to cost $45 to $55 million. Contract development and manufacturing organization (CDMO) Avid Bioservices had been looking to build out the Myford, Tustin, California production facility for several years to prepare for continued high demand from the biologics sector. Plans for a $30-40 million expansion finally materialized last July, but no date or details were…

J&J’s single-shot COVID-19 vaccine approved by FDA

The FDA has approved J&J’s single dose COVID-19 vaccine (Ad26.COV2.S) paving the way for distribution in the US. Last week, the US Food and Drug Administration (FDA) issued Johnson & Johnson’s (J&J) adenovirus type 26 COVID-19 vaccine with Emergency Use Authorization (EUA) making it the third vaccine available to US citizens. “After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization…

Moderna investing $400m in mRNA capacity for COVID-19 and beyond

Moderna aims to up capacity for its COVID-19 vaccine to 1.4 billion doses through investment in ‘flexible’ manufacturing, which it says will offset any risk from variants or future overcapacity. What a year it has been for Moderna Therapeutics. For the fourth quarter 2020, the firm reported sales of $200 million – up from nothing the previous year – as regulatory approvals began rolling in for its messenger RNA (mRNA) COVID-19 vaccine mRNA-1273. Since it began working on a COVID-19…

CDMO quadruples lentiviral capacity on the back of cell gene demand

VIVEbiotech has responded to the high demand for lentiviral vectors in the cell and gene therapy space by expanding its facilities. While no financial details have been disclosed, the Spanish contract development manufacturing organization (CDMO) said it is ramping up its manufacturing capacity and processes enabling it to respond to lentiviral demand. “We are based in San Sebastian in northern Spain, very close to the French border,” a spokesperson told BioProcess Insider. “Our facilities will be increased in around 3,000…