Deal-Making

Pluristem and Thermo Fisher Look to Plug Gaps in Cell Therapy Manufacture

Pluristem and Thermo Fisher will work to address the lack of technologies available to cell therapy manufacturers for the cultivation and processing of allogeneic products. “There is a lack of technologies for the cultivation and processing of allogeneic products whose potential is high scale production,” Yaky Yanay, president and co-CEO of Pluristem Therapeutics told BioProcess Insider. “Some of the gaps are in the technology itself, some are in the quality or the availability of raw materials.” To minimize some of…

Sonnet Selects Oncobiologics to Take I-O Assets into the Clinic

Sonnet BioTherapeutics has completed the discovery phase for its cytokine-based immunotherapy platform and begun a tech transfer to CDMO Oncobiologics. New Jersey-based biopharma firm Sonnet has announced it is planning to move its preclinical candidates towards the clinic, and has begun CMC development for up to four immuno-oncology candidates with a contract development and manufacturing organization (CDMO). John Cini, co-founder and chief scientific office of Sonnet, told BioProcess Insider the CDMO is fellow New Jersey-based firm Oncobiologics, which will manufacture…

Difficult Q4 for Avid as it Pushes to Diversify Customers and Fill Capacity

Avid Bioservices says it has worked aggressively to expand since becoming a pure-play CDMO but needs increased customer diversification and capacity utilization to secure future growth. After selling off its internal monoclonal antibody programs to Oncologie and dropping its Peregrine Pharmaceuticals tag, Avid Bioservices completed its transition to a pure contract development and manufacturing organization (CDMO). Six months on, the firm has reported a 62% year-on-year drop in its fourth quarter revenues to US$6.9 million (€5.9 million) and a fall…

French CDMO to Make Kymriah as Part of Novartis CAR-T Strategy

Novartis has selected France-based CELLforCURE as a CAR-T therapy manufacturing partner fresh from receiving European Medicines Agency (EMA) recommendation for Kymriah (tisagenlecleucel). Kymriah became the first chimeric antigen receptor (CAR) T cell therapy to receive approval in the US last August. Last month, marketing authorization holder Novartis came one step closer to bringing the therapy to Europe after receiving positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). In the wake of this recommendation, the Swiss…

Still Space for Multiple Neulasta Biosimilars, says Pfenex

Pfenex has deprioritized its pegfilgrastim biosimilar program but is reevaluating the market after Mylan’s recent success in the US. In June, the US Food and Drug Administration approved Mylan’s Fulphilia on its second attempt. While Fulphilia has become the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), there are several other firms looking to tap the market, including Coherus and Novartis subsidiary Sandoz. Clinical-stage development and licensing biotech Pfenex too has a pegfilgrastim biosimilar in its pipeline, PF529, but announced…

Entegris: ‘Flex Acquisition Helps Supply Chain Security’

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…

Mustang Opens $7m CAR-T Manufacturing Plant

Mustang Bio has opened a CAR-T cell manufacturing facility in Massachusetts it says has capacity to treat up to 800 patients annually. Fortress Biotech-owned Mustang has several chimeric antigen receptor T cell therapies in its pipeline and has opened a facility in Worcester, Massachusetts to support their development. “Total investment into the facility, including the build out and equipment was between US$5 million (€4.3 million) and $7 million,” Mustang Bio’s chief technology officer Knut Niss told BioProcess Insider. The current…

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

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

“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…

BioSymphony No. 1: Oncobiologics Wins First CDMO Deal

Sonnet BioTherapeutics has contracted Oncobiologics to develop and manufacture four undisclosed biologic compounds. The Master Services Agreement (MSA) with Sonnet BioTherapeutics is the first to leverage Oncobiologics’ BioSymphony Platform, consisting of in-house monoclonal antibody (mAb) development and manufacturing capabilities. Lawrence Kenyon, Oncobiologics’ CFO, told BioProcess Insider the platform is used in a small biotech company setting, which results in a “more efficient and timely process for bringing mAbs forward.” He continued: “Our goal, and the purpose of the platform, is…