Facilities & Capacity

Sarepta plans gene editing center; files DMD therapy for review

Genetic disease-focused firms need infrastructure says Sarepta, which shared plans for a gene editing center of excellence at the JP Morgan healthcare conference. The gene editing center will be in Durham, North Carolina according to CEO Douglas Ingram, who said investing in capacity and knowhow is key to Sarepta’s longevity. “If one is going to be an enduring genetic medicine company, we are going to need infrastructure,” he said, citing partnerships as an important part of the expansion. “We’re deepening…

WuXi Biologics adds Bayer drug product plant to growing network

WuXi Biologics has leased a drug product plant in Leverkusen, Germany from Bayer and is in negotiations to continue making hemophilia therapy Kovaltry for the Big Biopharma firm. The lease agreement – financials of which have not been divulged – gives Chinese contract development and manufacturing organization (CDMO) WuXi Biologics its first drug product facility outside of Europe. WuXi Biologics has been rampant in building up its manufacturing network, and while it has so far focused on constructing sites, the…

Merck pays Just-Evotec $15m for ‘J.POD’ manufacturing capacity

Merck & Co. has reserved capacity at Just-Evotec’s modular and biomanufacturing facility in Redmond, Washington, which is currently under construction. Months after German services firm Evotec acquired biologics development and manufacturing firm Just.Bio for $90 million (€81 million), plans were drawn up to construct a commercial-scale facility near Seattle in Washington state. While the plant is in the early stages of construction, Just-Evotec has confirmed Merck & Co. (known as MSD outside of North America) has reserved capacity at the…

Merck: 2023 the inflection point to address Gardasil demand

Two new bulk manufacturing facilities will come online by 2023 to feed the “incredible” global demand for HPV vaccine Gardasil, says Merck & Co. CEO Ken Frazier. Merck & Co. – known as MSD outside of North America – has for some time highlighted the human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 as products with dominant near-term commercial potential. While the two vaccines pulled in $3.2 billion (€2.9 billion) in global sales in 2018, the Big Biopharma firm has spoken…

Novartis opens its largest gene therapy plant to support Zolgensma

The doors have opened at a facility in Longmont, Colorado nine months after Novartis acquired it to support its gene therapy business unit AveXis. In April 2019, Novartis bought the Longmont facility from fellow Big Biopharma player AstraZeneca in efforts to grow out its gene therapy production network. Nine months on and the Swiss Biopharma has confirmed the site is open and prepped to support its AveXis unit in the production of therapies including Zolgensma (onasemnogene abeparvovec-xioi1), which was approved…

GVK Bio looks to ‘big-ticket’ manufacturing after building up bioservices biz

GVK Bio says it is adding master cell banking services to get in the GMP mindset, with a longer-term goal to expand into clinical and commercial production. In 2014, Indian contract research organization (CRO) GVK Bio landed both in the US and in the biologics services space by acquiring Aragen Bioscience. Aragen comprises of two sites in San Francisco offering efficacy studies, protein analytics, and cell line development services. At the time, “Aragen’s scientific excellence and expertise in large-molecule R&D…

Dendreon extends lease on Atlanta Provenge plant

Dendreon has extended the lease for the facility in Union City near Atlanta where it makes its prostate cancer cell therapy, Provenge (sipuleucel-T). The Chinese-owned cell therapy firm first leased the 155,000 square-foot facility in 2009, shortly before Provenge was approved by the US Food and Drug Administration (FDA). The extension covers use of the Union City site through to 2029. Christina Yi, chief operations officer at Dendreon said, “Over the past 10 years, we have grown locally, building key…

VGXI adds RNA suite to tap growing cell and gene therapy market

VGXI has set up an RNA pilot production suite at its facility in Woodlands, Texas citing growing demand from gene therapy developers. The GMP-grade mRNA manufacturing unit will support customer projects from initial plasmid construction through linearization, in vitro translation, mRNA purification, and comprehensive quality control testing according to VGXI. VGXI plans to launch clinical grade mRNA manufacturing services next year. Methodical expansion The pilot plant was set up as part of the VGXI licensing deal with the Houston Methodist…

Back to school: GE and UMass partner on academic viral vector plant

GE Healthcare has partnered with UMass to establish a viral vector manufacturing facility – its latest tie-in with academia in the cell and gene therapy space. The planned facility at the University of Massachusetts (UMass) Medical School’s Worcester campus will provide recombinant adeno-associated virus (AAV) vectors for preclinical research. High demand and a shortage of capabilities for viral vectors means the 3,220 square-foot facility, decked out with GE Healthcare’s viral vector FlexFactory platform, will help alleviate the current wait researchers…

Avid buoyant despite top client Halozyme’s restructure

Reorganization at key client Halozyme will not hit revenues says Avid Bioservices, which predicts ongoing facility revamp and expanding customer base to drive growth in the rest of FY2020. Halozyme Therapeutics recently said it would focus on its Enhanze delivery technology after HALO-301 – its candidate pancreatic cancer drug – fell short in Phase III trials. The San Diego biotech will close its oncology operations and reduce its headcount by approximately 55%, or approximately 160 positions. (Read Xconomy’s report here).…