A GMP facility equipped with bioreactors of up to 2,000 L will be the first commercial gene therapy production site in Spain, says CDMO Viralgen. Contract development and manufacturing organization (CDMO) Viralgen will invest upwards of €50 million ($55 million) at its site at the Miramon Technology Park in San Sebastian, Spain to add capacity for gene therapy manufacturing services. “We have a cGMP facility up and running that will have three production rooms by Q1 2020,†CEO Javier GarcÃa…
Facilities & Capacity
Fujifilm pumps $120m into US gene therapy development and manufacturing
An innovation center and additional cGMP manufacturing capacity make up Fujifilm Corporation’s plans to bolster its gene therapy capabilities at its site in Texas. It is no secret that the demand for gene therapy services is outstripping supply, with a shortage of viral vector capacity meaning contract development and manufacturing organizations (CDMOs) with manufacturing capabilities are rarely struggling to fill their space. To keep up with industry demand, Fujifilm Diosynth Biotechnologies (FDB) – the CDMO of Fujifilm Corporation – has…
Evotec to settle on Seattle for first commercial J.POD facility
Six months on from acquiring Just.Bio, Germany’s Evotec has laid plans to build its first US-based commercial biologics modular facility in Seattle. German R&D firm Evotec jumped into the biologics manufacturing space in May 2019 through the $90 million acquisition (€82 million) of Just.Bio. The offerings gained from Just.Bio include a large molecule manufacturing design platform known as J.DESIGN, and a lab and computational tool for rapid development of a high-yielding manufacturing process called JP3. Evotec also gained a cGMP…
AGC Bio to plough $18m in US and EU facilities
CDMO AGC Biologics will invest 2 billion Yen ($18.4 million) to increase biopharmaceutical production capacity at facilities in the US and Europe. The plan will see the contract development and manufacturing organization (CDMO) add a 500-liter bioreactor for mammalian cell cultures at its facility in Seattle in the US. The firm said “this will serve better, pharmaceuticals companies with biopharmaceuticals at the earlier stages of development and clinical trials.†It will also install a purification line at its manufacturing plant…
Thermo to add culture media production capacity at Scotland site by 2021
Thermo Fisher Scientific will spend $24 million (€22 million) to up culture media capacity at its Inchinnan, Scotland facility. The firm said it will add large-volume liquid manufacturing capacity for cell culture media by 2021. Cory Stevenson, president of Thermo Fisher’s bioproduction business, said increased biopharmaceutical industry demand prompted the investment. “More and more customers are outsourcing their liquid manufacturing to ensure the highest quality while delivering efficiency.†“This investment will expand capabilities and expertise at our existing cell culture…
Catalent reports 50% y-o-y biologics growth as gene therapy enters the mix
Catalent says the integration of Paragon Bioservices’ gene therapy assets is progressing ahead of expectations. The CDMO reported quarterly sales in its biologics division of $189 million. For the first quarter of fiscal year 2020, Catalent reported revenues of $665 million (€600 million). For the contract development and manufacturing organization’s (CDMO) biologics division the quarter saw sales of $189 million, up 50% on the same period last year. Catalent has grown its biologics offering over the past few years, investing…
Cognate buys Cobra to boost gene therapy CDMO capabilities
Cell therapy CDMO Cognate Bioservices will add plasmid DNA and viral vector capabilities through the acquisition of Swedish manufacturer Cobra Biologics. Memphis, Tennessee-based contract development and manufacturing organization (CDMO) Cognate has entered into an agreement to acquire Cobra for an undisclosed fee, led by existing Cognate investor EW Healthcare Partners. The deal adds to Cognate’s presence in the regenerative medicine space by bringing on board plasmid DNA and viral vector manufacturing capacity and expertise, complementing its own autologous and allogeneic…
Biomanufacturing capacity: 45% growth but new blockbusters could leave shortage
Biomanufacturing volumes are set to increase by 45% to 6,400 kL over five years. But with demand growing at over 10% per year and the potential arrival of Alzheimer’s MAbs, there may still be a shortage in capacity. In a report published in conjunction with the CPhI Worldwide meeting in Frankfurt, Germany this week, Dawn Ecker, director of bioTRAK Database Services, BioProcess Technology Group, BDO, spoke of the current capacity availability within the biologics industry and potential restraints in the…
Bio-Techne confirms $50m reagents plant to support CGTs
Bio-Techne will build a 50,000 square-foot plant in Minnesota with an initial capacity of $140 million of E. coli-derived recombinant proteins to support cell and gene therapy developers. After months of talk, life sciences services and consumables firm Bio-Techne has laid concrete plans to build a facility in St Paul, Minnesota to produce GMP reagent proteins for use in cell and gene therapy applications. “The facility is expected to go through qualifications in approximately one year, with commercial sales expected…
Gene therapy demand drives Cytovance pDNA expansion
Cytovance Biologics has added plasmid DNA (pDNA) production capacity at its Oklahoma City facility citing growing demand from gene therapy developers. The single-use production system is capable of making both critical reagent grade – for research – and cGMP grade pDNA in quantities ranging from 1g to 50g. It can manufacture smaller quantities for R&D. Jesse McCool, Cytovance chief technology officer (CTO), framed the investment as part of the firm’s effort to position itself as a key gene therapy supply…