Facilities & Capacity

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…

Moderna times: Catalent captures another COVID contract

Catalent has announced it will support a third ‘Operation Warp Speed’ COVID-19 candidate by providing commercial fill/finish for Moderna Therapeutics’ mRNA vaccine. The deal announced this week will see contract development and manufacturing organization (CDMO) Catalent provide vial filling and packaging capacity from its facility in Bloomington, Indiana for Moderna Therapeutics’ vaccine candidate mRNA-1273. “Moderna will leverage the site’s existing filling lines and recent packaging expansion, which provides fully automated and high-speed packaging capabilities to accelerate manufacturing timelines,” a Catalent…

Cytiva bolsters CDMO business with MA expansion

Cytiva has upgraded its Fast Trak facility in Marlborough in response to demand for pre-clinical to Phase II biomanufacturing services from small to mid-sized companies. Under the firm’s Fast Trak contract development and manufacturing brand, Cytiva has expanded its Marlborough cGMP facility to 60,000 square feet. The plant offers biopharma access to services from preclinical to Phase II, including process development, clinical batch manufacturing, analytical development, and QA/QC/regulatory support. Olivier Loeillot, senior vice president of BioProcess at Cytiva, did not…

Manufacturing pace key for COVID-19 vaccines hoping to jump to ‘Warp Speed’

Ease of manufacturing scale up may determine which candidates advance furthest in the US government’s partnership with industry to speed COVID-19 vaccines to patients. Senior government officials also discussed approval standards, how a vaccine would be distributed, and how much the government and Americans could pay in a 16 June press call. The ability for a COVID-19 vaccine to be manufactured quickly and at scale will be a key factor in determining which potential candidates advance through Operation Warp Speed,…