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Hyperstack Shortage Caused by Gene Therapy Surge

The adoption of viral vector technology in cell and gene therapy has led to six month waiting lists for multilayer culture vessels. Hyperstack vendor Corning says it will more than double its manufacturing capacity to deal with the demand. Despite being a registered brand owned by Corning Life Sciences, ‘hyperstack’ has become a common term to describe multilayer, scalable, and single-use culture flasks. They are used to produce viral vectors and gene therapies, and are in huge demand, according to…

Entegris: ‘Flex Acquisition Helps Supply Chain Security’

by BPI Staff

Entegris has acquired Flex Concepts, adding upstream tech to its bioprocessing equipment offering. The deal – financial details of which have not been divulged – will see Entegris add bioprocessing single-use bags and fluid transfer solutions to its life sciences offering. “Flex Concepts manufactures quick turn custom configured products primarily for the biopharmaceutical industry. They sell products to some of the top pharma and biopharma companies,” Eric Isberg, director of Life Sciences for Entegris, told BioProcess Insider. “Flex had primarily…

Industry Looks to ‘Lucrative’ Opportunities for Off-the-Shelf Cell Therapies

by Dan Stanton

Allogeneic cell therapies have greater commercial potential than autologous products, an industry survey finds. Respondents also believe there are a lack of third-party capabilities to make these new therapies. When Novartis’s Kymriah (tisagenlecleucel) received the regulatory thumbs up in August 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb described regenerative medicines as being “no longer the stuff of science fiction.” The approval of Gilead/Kite’s Yescarta (axicabtagene ciloleucel) weeks later helped cement the safety and commercial potential of CAR-T…

GE Healthcare Spin-Off: “A Major M&A Chip Off the Table”

by Dan Stanton

GE will separate its Healthcare division over the next two to three years in efforts to reduce debt. The news may disappoint acquisition-hungry life science rivals Thermo Fisher and Danahar, say analysts. John Flannery, chairman and CEO of General Electric (GE) announced today plans to separate GE Healthcare, along with industrial services firm BHGE, in efforts to “unlock both a pure-play healthcare company and a tier-one oil and gas servicing and equipment player.” The industrial conglomerate GE has struggled over…

Pfenex: Bacterial System Overcomes Protein Challenges, Inhouse and Out

by Dan Stanton

“The more you engineer a protein, the less natural it becomes,” says Pfenex executive Patrick Lucy. The firm is using its clinically validated microbial expression platform to overcome these challenges for both its own product pipeline and its partners. In May, Pfenex announced positive Phase III data showing its lead candidate PF708 is comparable with Eli Lilly’s osteoporosis drug Forteo (teriparatide). The candidate – classed as a biosimilar in Europe but being filed in the US as a therapeutic equivalent…

WuXi Pumps $20m into Conjugation and Fill/Finish Site

by BPI Staff

WuXi Biologics has begun building a biologics conjugation and drug product plant in China to support antibody-drug conjugate (ADC) services. To be known as DP3, the 6,000m2 facility will be the third drug product site for the contract development and manufacturing organization (CDMO) and is expected to be open next year. The facility in Wuxi City, China will offer both clinical and commercial antibody-drug conjugate (ADC) services and will be an extension of similar conjugation and fill/finish operations at WuXi’s…

Sartorius Pumps $100m in Puerto Rico, Doubles SU Bag and Filter Capacity

by Dan Stanton

North American demand for aseptic filters and single-use bags drove Sartorius to expand its facility in Yauco, Puerto Rico. German bioprocessing supplier Sartorius began expanding its Yauco production and distribution center in 2016 and has invested more than US$100 million (€86 million), according to spokesperson Timo Lindemann. The investment brings Sartorius an additional area covering nearly 190,000 square meters – around two million square feet – he told BioProcess Insider. “A focal area of investment will be on expanding aseptic…

Jefferson Bioprocessing Institute Aims to Feed High Demand for Skilled Workers

by BPI Staff

GE Healthcare and Ireland’s NIBRT will support the Jefferson Institute for Bioprocessing, set to open its doors next year. The site in Pennsylvania will train around 2,500 people in biomanufacturing operations per year. “There is high demand for trained professionals in the growing fields of biologics,” Debbie Goldberg, director of Public Relations at Jefferson (Philadelphia University + Thomas Jefferson University), told BioProcess Insider. As such, the education and training institute for bioprocessing has selected a site and will open its…

Patheon On Keeping Up With Biologics Demand

by Dan Stanton

Patheon is doubling its biomanufacturing capacity through a $50 million investment in Missouri. We spoke with the CDMO about the continued demand for biologics services and its relationship with owner Thermo Fisher. In April, contract development and manufacturing organization (CDMO) Patheon announced plans to add 16,000 L of single-use capacity at its St Louis, Missouri facility. The US$50 million (€43 million) expansion effectively doubles the firm’s global biomanufacturing capacity. According to David Kenyon, senior director of Global Scientific and Technical…

Benitec Scale-Up Success with Insect-Based Tech Ahead of IND Filing

by Dan Stanton

Benitec Biopharma says it has successfully scaled-up its investigational oculopharyngeal muscular dystrophy (OPMD) gene therapy using a baculovirus-based expression system. Benitec Biopharma’s lead candidate BB-301 is a gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD), a disease caused by a mutation of the poly(A)-binding protein nuclear 1 (PABPN1) gene. The candidate received orphan drug status from the US Food and Drug Administration (FDA) in January this year, and the firm hopes to bring it into the clinic by…