Author Archives: Dan Stanton

We are in the ‘golden age for the CDMO space,’ says Thermo Fisher

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With over 75% of new molecules coming from small and emerging biotech, opportunities for third-party manufacturers have never been so large says Thermo Fisher CEO Marc Casper. Thermo Fisher jumped into the third-party biomanufacturing space in August 2017 through its acquisition of contract development and manufacturing organization (CDMO) Patheon for around $7.2 billion (€6.4 billion). The firm has also had capabilities in the CDMO since the early 2000s through its clinical trials’ service offerings. Speaking at the 2019 Barclays Global Healthcare Conference,…

March 15, 2019

Pall teams with Broadley-James on single-use pH sensors

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Pall Corporation has struck a deal to integrate Broadley-James’ single-use probe and flow cell pH sensors in its disposable bioprocessing offerings. The deal means Broadley-James’ single-use probe and flow cell pH sensors will be made exclusively available through Pall Biotech’s upstream and downstream single-use technologies. The single-use pH sensors use glass electrochemical technology, meeting international standards, and are designed to include a calibrated buffer storage environment to overcome constraints during pre-integration of glass pH sensors into consumables. The two firms…

March 14, 2019

Batch to the future: Amid single-use and 100 g/L, stainless steel will continue to shine

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Titers are up and single-use is widespread, but commercial drugmakers will continue to use stainless steel bioreactors for unmet medical needs, GE’s Parrish Galliher told BPI West delegates. Industry convened in Santa Clara, California, for BPI West this week to hear the latest bioprocessing developments and share manufacturing strategies. While much of the attention focused on productivity improvement and disruptive technologies, Parrish Galliher, CTO of Upstream at GE Healthcare Life Sciences and founder of Xcellerex, told delegates not to lose…

March 14, 2019

Pfizer’s trastuzumab becomes US biosimilar number 18

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The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer’s version of Roche cancer drug Herceptin (trastuzumab). Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fourth version of the Roche bestselling monoclonal antibody (MAb) to receive the regulatory thumbs up in the US. Mylan’s Ogiviri received approval in December 2017 and in the past…

March 12, 2019

CDMO Fujifilm buys Danish plant from Biogen for $890m

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Biogen has sold a 90,000 L mammalian cell culture to Fujifilm Diosynth Biotechnologies. The deal propels the CDMO into the top 10 of biomanufacturers based on tank capacity. The manufacturing plant in Hillerød, Denmark will be taken over by contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies, with all the approximately 800 staff members being retained, in the $890 million (€790 million). “The plan is for Fujifilm to use the Hillerød site to produce commercial products for Biogen as well…

March 12, 2019

Cellectis builds out CAR-T network, creates 200 jobs in NC

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Cellectis will build a clinical and commercial production plant in Raleigh at a reported cost of $68 million and a raw material facility in France to support its allogeneic CAR-T pipeline. France-headquartered Cellectis is looking to develop off-the-shelf chimeric antigen receptor (CAR) T-cell therapies using its TALEN gene-editing technology. Cellectis manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMOs) but is now looking to securing inhouse supply through investments in Raleigh, North Carolina, and…

March 12, 2019

Biosimilar… but different: FDA tweaking nonproprietary name guidance

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The US FDA has proposed changes to its nonproprietary naming guidance to remove the proposed controversial four-letter suffix from older biologics. In 2017, the US Food and Drug Administration (FDA) published guidance to include a random four-letter suffix to the international nonproprietary names (INN) of all biological products. The ruling essentially distinguished a biosimilar from its reference product, so Amgen’s reference product Neupogen, for example, is known as ‘filgrastim-jcwp,’ while Sandoz’s biosimilar version Zarxio – the first biosimilar approved and…

March 12, 2019

Thermo Fisher: Is there a ‘monster deal’ on the horizon?

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With its robust balance sheet, a large acquisition by Thermo Fisher within the fragmented life science industry would not be surprising, an Evercore ISI analyst says. Over the past few years, the life science industry has seen continual disruption and consolidation through M&A activity, but according to Evercore ISI analyst Ross Muken the space remains fragmented. Muken noted this following a breakfast meeting with Marc Casper, CEO of Thermo Fisher. Thermo Fisher has been one of – if not –…

March 11, 2019

Life sciences ‘continues to rip’ for Germany’s Merck

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With a 14.8% year-on-year growth in its Process Solutions business, Merck KGaA has reported another strong year for its life sciences division. For the full year 2018, Germany’s Merck KGaA reported net sales of €14.8 billion ($16.6 billion) across all its divisions, a growth of 2.2% year-on-year. Its life sciences business pulled in €6.2 billion ($7 billion), up 5.2% on 2017 with a large contribution from its Process Solution business – which includes its MilliporeSigma unit – of €2.5 billion,…

March 8, 2019

Precision Bio $100m IPO to support allo CAR-T build-out

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Precision Bio hopes the initial public offering (IPO) will advance its off-the-shelf CAR-T candidates, based on its ARCUS genome editing platform. North Carolina-based Precision Bio has applied for a listing on the Nasdaq exchange. According to its Form S-1 filed with the SEC, the firm will use the anticipated $100 million (€88 million) raised in the IPO to advance and expand its clinical and preclinical development programs. This includes plans to complete a Phase I/IIa clinical trial for its CD19…

March 8, 2019