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Pfizer pumps $500m into NC gene therapy site

The expansion in North Carolina will create 300 jobs and is the latest investment by Pfizer in its burgeoning gene therapy network. The $500 million (€450 million) investment in Sanford, North Carolina will see the Big Pharma firm construct a facility to support production of its recombinant adeno-associated virus (rAAV) vectors for use in its gene therapies and vaccines. Mike McDermott, president of Pfizer Global Supply, said the Sanford expansion will “strengthen Pfizer’s leadership in gene therapy manufacturing technology” and…

Orchard to open CA plant in 2021 to support gene therapy pipeline

by Dan Stanton

Orchard Therapeutics says it will balance its existing CMO network with a planned facility in Fremont to create the infrastructure needed to commercialize its gene therapies. Orchard’s pipeline of ex vivo autologous gene therapies include the former GSK hematopoietic stem cell (HSC) gene therapy Strimvelis – approved by the EMA in 2016 – and five clinical stage programs. The firm has been reliant on its network of contract manufacturing organizations (CMOs) to produce these therapies, but late last year it announced it…

Lonza to simplify vein-to-vein supply chain with Vineti partnership

by Dan Stanton

The cell and gene therapy industry is at a global inflection point says Lonza as it teams with logistics firm Vineti to remove the supply chain hurdles affecting the space. The non-exclusive partnership will see contract development and manufacturing organization (CDMO) Lonza incorporate Vineti’s real-time end-to-end supply chain platform into its cell and gene therapy offering. “The Vineti and Lonza partnership is a preferred business collaboration to drive manufacturing efficiencies in the C&GT [cell and gene therapy] manufacturing process by…

Bio-Techne: $50m reagent plant will support cell & gene therapies

by Dan Stanton

Plans for a $50 million GMP reagent facility in Minnesota are materializing at Bio-Techne as it looks to support the burgeoning cell & gene therapy sector. In its third quarter FY2019 financial call, life sciences services and consumables firm Bio-Techne spoke of intentions to build a $40 million (€36 million) GMP facility in Minneapolis, Minnesota to produce reagent proteins for use in cell and gene therapy applications. Three months on, the firm has said plans are now laid to invest…

COGS crisis: Cell therapy sector must rethink CMC says expert

by Gareth Macdonald

The cell therapy sector faces a cost of goods sold (COGS) crisis and needs to get beyond the “product is the process” mind-set says Anthony Davies, CEO of Dark Horse Consulting. Cell and gene therapies have attracted a lot of attention in recent years. In part this is because drugs like Yescarta, Kymriah and Zolgensma have been approved as one-off cures. However, their cost – $373,000, $475,000 and $2.1m per vial in the US, respectively – has also seen them…

A booster shot for vaccines: Univercells working to cut production costs

by Gareth Macdonald

Vaccines cost too much to make according to Univercells, which aims to have a novel platform ready for commercial-scale production by 2020. Vaccines have had a dramatic impact on human health. One recent study argued that vaccine development “represents humankind’s most important and successful endeavor… over the last 200 years” [1]. Many diseases that caused millions of deaths in generations past have been stopped in their tracks by industry-supported vaccination programmes run by entities like World Health Organization (WHO), UNICEF and…

GE: Learning from MAb automation to tackle CAR-T

by Dan Stanton

GE Healthcare says monoclonal antibodies laid the groundwork for its workflow technologies, allowing accelerated uptake of automation in the autologous cell and gene therapy space. In May, bioprocessing tools and services firm GE Healthcare launched its Chronicle automation software for cell therapy manufacturing. The offering supports the complete workflow for cell therapy products including the optimization of manufacturing from process development to commercialization. Talking to Bioprocess Insider at the BPI Theater at BIO in June, Catarina Flyborg, GM of GE’s…

Garbage in, garbage out: Raw material quality crucial for cell & gene therapies

by Dan Stanton

Cell and gene therapy makers have suffered manufacturing setbacks, but experts working in the supply chain say ensuring high quality raw material is the key to success. Manufacturing issues have plagued the few advanced therapies to have made it to the market. Dendreon’s Provenge (sipuleucel-T) suffered from high complexity of manufacturing and administration, Novartis’ Kymriah (tisagenlecleucel) saw some variability in its product specifications, and – most recently – Bluebird Bio has been accused of lacking manufacturing readiness for its recently…

Merck builds up Gardasil network again with $680m NC injection

by Dan Stanton

Merck & Co. will build a 225,000 square-foot facility in Durham to support production of its HPV vaccine Gardasil, creating 400 jobs. Merck will report its second quarter 2019 results on July 30, but for the previous quarter the firm saw a 31% year-on-year increase in sales of its human papillomavirus (HPV) vaccines Gardasil and Gardasil 9, which pulled in sales of $838 million (€752 million). Adam Schechter, Merck’s president of Global Human Health, said last year that his firm…

Lonza building out capacity to prep for ADC boom

by Dan Stanton

CDMO Lonza already supports three of the five commercially available antibody-drug conjugates (ADCs) and is adding two news suites in Switzerland in preparation of future demand. Contract development and manufacturing organization (CDMO) Lonza will expand its bioconjugation facility in Visp, Switzerland in readiness for a new wave of antibody-drug conjugates (ADCs) coming through the clinic. “Many bioconjugates are on expedited programs and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and…