Facilities & Capacity

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).…

AGC Bio looks to tap growing plasmid DNA market

AGC Bio’s expanded offering at its site in Heidelberg will serve a plasmid DNA (pDNA) space growing at 20 % CAGR, the CDMO says. Contract development manufacturing organization (CDMO) AGC Bio has completed a pDNA manufacturing process improvement project at its site in Heidelberg, Germany. The firm says this will enable the extension of the offer in hosts and plasmids with scales of 1 L to 10 L for High Quality pDNA, and will be easy to scale up to…

Sanofi wins US HHS $226m contract to expand PA vaccine capacity

The US Government has contracted Sanofi Pasteur to increase recombinant vaccine capacity at its Pennsylvania plant as part of US efforts to prepare for a flu pandemic. The US Department of Health and Human Services (HHS) shared details of the six-year, $226 million contract this week. Sanofi will work with the Biomedical Advanced Research and Development Authority to (BARDA) double capacity at the plant. The contract includes options that would see Sanofi retrofit a second facility to make adjuvant; develop…