Facilities & Capacity

Moderna adds Rovi to roster of coronavirus vaccine CDMOs

Rovi has joined the list of CDMOs that will make Moderna’s coronavirus vaccine candidate if it is approved. Rovi – also known as Laboratorios Farmacéuticos Rovi – will provide commercial fill-finish and packaging services for mRNA-1273 at its facility in Madrid, Spain under a contract announced last week. Moderna said Rovi would support production of hundreds of millions of doses to supply markets outside of the US starting in early 2021. The US firm also said ROVI would hire extra manufacturing operations and…

Samsung Biologics eyes fourth plant as capacity fills

The 364,000 L of bioreactor capacity at Samsung Biologics’ site in Korea will be fully utilized by 2022, says the CDMO as it contemplates a new facility. Contract development and manufacturing organization (CDMO) Samsung Biologics has grown its site in Songdo, Incheon since its inception in 2011 with three plants hosting a total of 364,000 L of mostly stainless-steel bioreactor capacity. Plant number one has 30,000 L of capacity from six 5,000 L tanks. Plant number two offers 150,000 L…

Bionova building CA manufacturing plant to feed biologics demand

Having heard the demand from customers to add GMP biomanufacturing, Bionova has begun construction of a facility in Fremont boasting two 2,000 L single-use trains. Bionova Scientific has started to cement the ‘M’ in CDMO (contract development and manufacturing organization) after it broke ground on a 36,000 square-foot production facility last week at its site in Fremont, California. According to the firm, the “well-documented need for high-quality manufacturing capacity in the industry” helped drive the expansion, as did the call…

Novavax says COVID $1.6bn funding helps secure US-based supply chain

The ‘Operation Warp Speed’ $1.6 billion funding boost will help support the large-scale manufacture of COVID-19 vaccine candidate NVX‑CoV2373, says Novavax. Novavax has become the beneficiary of the largest funding by Operation Warp Speed – the US government’s response to the expedite vaccines and therapeutics against the novel coronavirus – to date, receiving $1.6 billion it says will be used to aid clinical development and secure manufacturing for NVX‑CoV2373. “In addition to establishing scale-up manufacturing capacity to deliver 100 million…

Rentschler and Vetter team to take on rising drug cost and complexity

CDMOs Rentschler Biopharma and Vetter say demand for lower cost, more streamlined manufacturing services prompted partnership. The Germany-based contract development and manufacturing organizations (CDMOs) announced the formation of a strategic alliance on Monday. The idea is to offer customers Rentschler’s drug substance manufacturing capacity in combination with Vetter’s aseptic fill and finish and secondary packaging services. Rentschler spokeswoman Cora Kaiser cited market dynamics as the driver for the collaboration, explaining “Drug development is growing increasingly complex and cost intensive. Biopharmaceutical…

Sarepta: ‘We have a voracious appetite for gene therapy manufacturing capacity’

Inhouse capabilities coupled with capacity at CDMOs including Thermo Fisher and Catalent have allowed Sarepta Therapeutics to rapidly advance its gene therapy pipeline, says management. Sarepta Therapeutics has 43 programs in its pipeline, the majority of which are gene therapies and gene editing-based products. Leading gene therapy candidates include SRP-9001 Micro-dystrophin for Duchenne muscular dystrophy [DMD] and SRP-9003 for limb-girdle muscular dystrophy (LGMD). To support these developmental programs, the firm adopted two years ago what it calls “a hybrid manufacturing…

Advanced therapy news: RoslinCT, Marker, Freeline to establish facilities

As the surge in cell and gene therapies entering and progressing through the clinic continues, we highlight manufacturing plans from Marker Therapeutics, Freeline, and CDMO RoslinCT. First up in this cGMP manufacturing investment roundup is clinical-stage immuno-oncology company Marker Therapeutics, which has announced plans to lease a facility in Houston, Texas The 48,500 square-foot plant, expected to be operational in 2021, will support the firm’s T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. “We are…

Avid preps to kick-off $30-40m manufacturing expansion

Though no date has been set, Avid Bioservices says it is undertaking pre-engineering and design work on a long-awaited facility aimed at supporting soaring demand for biomanufacturing services. For a while, contract development and manufacturing organization (CDMO) Avid Bioservices has been pushing to build out its Myford, California production facility to prepare for continued high demand from the biologics sector. But on its latest financial call, management said the firm is readying itself for the expansion in preparation for growth…

CRISPR follows plant announcement with share offer

CRISPR Therapeutics will build a manufacturing facility in Framingham, Massachusetts to make cell therapies for trials and commercialization. The facility will accelerate its clinical development efforts according to CRISPR, which said it plans to hire up to approximately 100 full-time employees. CRISPR said the plant is being designed to provide GMP manufacturing in compliance with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations and guidelines. CEO Samarth Kulkarni stressed that the facility will not replace the…

COVID programs could commandeer CDMO capacity, warns industry group

CDMO advocacy group the PBOA says regulatory and end-user flexibility will be key in addressing bottlenecks caused by the pressing need for COVID-19 vaccine and therapy capacity. Industry’s rapid push to develop therapies and vaccines against COVID-19 caused by the coronavirus SARS-CoV-2 has led to many announcing production deals with contract development and manufacturing organizations (CDMOs). For example, Moderna Therapeutics, for its late-stage mRNA vaccine, has secured production capacity with Catalent and Lonza. Meanwhile, it is becoming increasingly hard to…