Author Archives: Dan Stanton

WuXi Biologics expands US presence with 6,000L NJ plant

Chinese CDMO WuXi Biologics has entered a ten-year lease on a clinical biomanufacturing facility in New Jersey weeks after securing a production site in Massachusetts. The contract development and manufacturing organization (CDMO) announced yesterday it has signed a 10-year lease agreement for a clinical manufacturing facility in Cranbury, New Jersey. The 66,000 square-foot plant, expected to be operational later this year, will house 6,000 L of single-use bioreactors, a WuXi Biologics spokesperson told us, as well as process development (PD)…

Achilles becomes fifth company to take residency at CGT Catapult

Achilles Therapeutics will produce clinical material for its personalized T cell candidate from the Cell & Gene Therapy (CGT) Catapult. The Stevenage, UK-based CGT Catapult – established by non-departmental government body Innovate UK in 2017 to support the burgeoning sector – recently completed an expansion, adding six clean rooms. The first company to take manufacturing in this expanded space is Achilles Therapeutics, which is developing autologous cell therapies against advanced non-small cell lung cancer and recurrent metastatic melanoma. Using T…

COVID-19 round-up: Vaccine capacity M&A, deals and task orders

Emergent has received $628 million to support vaccine production; Novavax buys Czech Republic-based Praha Vaccines; Vaxart contracts Kindred Biosciences. Just another week in the fight against COVID-19. Emergent Biosolutions is working on several projects to support the development of COVID-19 vaccines but has been buoyed by a US government task order of $628 million to support rapid domestic production through 2021. The task order forms part of a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department…

COVID-19 vaccine: A $14bn opportunity for bioprocess vendors

The big four bioprocess vendors – Thermo Fisher, Danaher, MilliporeSigma, and Sartorius – are set to benefit from the commercial success of COVID-19 vaccines, according to Evercore ISI. There are a host of vaccine candidates targeting the novel coronavirus (SARS-CoV-2) moving into and through the clinic, and while there is no guarantee of success a breakthrough product will be a lucrative market opportunity. Specifically, a commercialized product could be worth upwards of $100 billion (€89 billion), according to the team…

A Boulder move: AGC Biologics snaps up former AZ plant for $100m

AGC Biologics has expanded its CDMO operations by acquiring a mothballed commercial-scale manufacturing facility from AstraZeneca and says it will hire 150 staff going forward. In January 2019, Anglo-Swedish firm AstraZeneca announced the closure of two Colorado-based biomanufacturing facilities acquired in 2015 and 2016 from fellow pharma giant Amgen. The decision to close the sites in Longmont and Boulder formed part of a plan to consolidate its biologics manufacturing network into one large-scale drug substance facility at its site in…

Thermo Fisher adding 12,000L to bio-capacity with Swiss plant from CSL

Thermo Fisher will take over operations at CSL’s biomanufacturing site in Lengnau – currently under construction – adding 12,000 L of stainless-steel bioreactor capacity to its CDMO network. CSL Behring broke ground on the 1.5 million square-foot site in Lengnau, near Bern in Switzerland back in 2015, with plans to use the facilities to manufacture recombinant products, specifically in its hematology pipeline. At the time, the firm, which invested approximately CHF 1 billion ($1 billion) into the project, said the…

AveXis redeploying CDMO gene therapy capacity to support COVID-19 project

The Novartis gene therapy business will contribute its technology and dedicated space at a facility run by CDMO Catalent to help produce a COVID-19 vaccine being developed by Massachusetts-based researchers. Massachusetts Eye and Ear and Massachusetts General Hospital have teamed to develop a vaccine candidate that uses an adeno-associated virus (AAV) vector to deliver and express the Spike gene of the SARS-CoV-2 virus, which causes COVID-19, to elicit an immune response. The developers have turned to AveXis, the gene therapy division…

With $60m in hand, Gamida looks to build out cell therapy infrastructure

Gamida Cell will initiate a BLA submission for lead cell therapy omidubicel later this year and grow inhouse manufacturing capabilities to support production of cancer candidate GDA-201. Israeli cell therapy company Gamida Cell raised $60 million (€55 million) last week through a public share offering. The money will be used to support the approval application and manufacturing capabilities of its cell therapy products, the firm said on an investor call last week. Lead candidate omidubicel – formerly known as NiCord…

WuXi Biologics strikes deal to bring 8,000 L single-use plant to MA

Two years after announcing plans to expand into the US, WuXi Biologics has signed a land deal allowing construction of a $60 million plant in Worcester, Massachusetts. For Chinese contract development and manufacturing organization (CDMO) WuXi Biologics, 2018 was a landmark year, signaling major growth through the announcement of several expansions. Along with several additional single-use biomanufacturing plants in China, the firm set its sites on global expansion, first announcing plans for a 54,000 L plant in Ireland, then a…

Cell and Gene Therapies Get a Reality Check: A Conversation with Anthony Davies of Dark Horse Consulting Group

As founder of cell and gene therapy (CGT) specialist firm Dark Horse Consulting Group in California, Anthony Davies speaks from a quarter century of experience including former positions at Onyx Pharmaceuticals, Syrrx, ZymeQuest, Serologicals, Geron Corporation, Capricor, and 4D Molecular Therapeutics — and he currently serves on the board of directors for TrakCel and the scientific advisory boards for Akron Biotech and BioLife Solutions. In his plenary address at the Phacilitate 2020 Leaders World conference (part of Advanced Therapies Week…