Facilities & Capacity Archives - Page 39 of 73 - BioProcess InternationalBioProcess International

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

by BPI Staff

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

by Dan Stanton

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

by Gareth Macdonald

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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’

by Sarah Karlin-Smith

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,…

Emergent to add gene therapy capacity through $75m plant expansion

by Gareth Macdonald

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector. The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts. At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000. Emergent said the investment will establish a multi-suite production operation with 1,000…

Inhouse and out: AstraZeneca secures COVID-19 vaccine capacity

by Dan Stanton

Contracts with CDMOs Catalent, Emergent Biosolutions, Cobra, and Novasep and the retrofitting of a facility in Ohio will support AstraZeneca and the Oxford University’s COVID-19 vaccine candidate. AstraZeneca was among the second wave of Big Pharma firms to enter the rush to develop a vaccine against the coronavirus SARS-CoV-2 that causes COVID-19 in April when it teamed with the Jenner Institute and the Oxford Vaccine Group at the University of Oxford on its ChAdOx1 nCoV-19 program. Production of the vaccine…