Author Archives: Dan Stanton

Biogen stock plunges $18bn on Alzheimer’s MAb failure

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Biogen lost around 30% of its value after discontinuing a Phase III trial of Alzheimer’s disease candidate aducanumab. The CRO involved will also take a hit in revenues. Codeveloped with Eisai, aducanumab had been undergoing Phase III clinical trials in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. But the firms took the decision to halt the study this week – along with the EVOLVE Phase 2 safety study and the long-term extension of…

March 22, 2019

German Merck eyes membrane plant within €2bn investment

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Merck KGaA has pledged to double the investment in its Darmstadt, Germany site to support numerous manufacturing, R&D and infrastructure projects. In 2015, Merck announced plans to invest €1 billion ($1.1 billion) over five-years at Darmstadt, the location of its global headquarters and a major biomanufacturing hub for the Big Pharma firm. Four years later and the firm says it is doubling down on its investment, spending a further €1 billion until 2025 to support various projects at Darmstadt and…

March 22, 2019

Genentech on tech transfer: ‘Small volumes are all a bit new to us’

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Genentech says it is looking to disruptive technologies for a fast and agile response to capacity demands as its portfolio evolves away from large volume biologics. At BPI West in Santa Clara last week, Eric Fallon, senior director of Pharma Technical Innovation of Technology & MSAT at Genentech, spoke about the difficulties in driving performance and carrying out tech transfers within its large global manufacturing network. “Our manufacturing infrastructure is built around large, economies of scale, facilities. They can be…

March 20, 2019

Access to smart money a key life science growth driver, Dynamk

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Bioprocess executives moving to the financial sector shows a strong desire for continued investment in the life sciences space, says Daniella Kranjac from VC firm Dynamk. Reinhard Vogt joined venture capital (VC) firm Dynamk Capital as a new general partner and managing director earlier this year, following an illustrious career in bioprocessing. Bioprocess Insider recently spoke with Vogt about major investment opportunities, but in this follow-up Q&A, Daniella Kranjac, co-founder and managing partner at Dynamk, explains how his expertise strengthens…

March 20, 2019

Thermo Fisher injecting $150m in Patheon fill & finish plants

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Two facilities in Italy and a site in Greenville, North Carolina are being expanded to support demand for biologics aseptic liquid and lyophilized product development and manufacturing. Since Thermo Fisher acquired contract development and manufacturing organization (CDMO) Patheon for $7.2 billion (€6.4 billion) in August 2017, the firm has invested $50 million to double single-use capacity at the St Louis, Missouri biologics facility. Now Thermo Fisher is investing further in the Patheon network through expansions at three global fill & finish…

March 19, 2019

Lonza’s POC CAR-T tech: Out with the cleanroom, in with the Cocoon

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Lonza will provide its point-of-care (POC) Cocoon cell therapy platform to the Sheba Medical Center in Israel to provide automated and closed CAR-T manufacturing. The collaboration between Sheba and Swiss contract development and manufacturing organization (CDMO) Lonza aims to confirm the benefits of using the Cocoon system to make autologous cell therapies in a POC environment. “The partnership with Sheba will test the Cocoon in the clinical setting,†Eytan Abraham, head of Personalized Medicine at Lonza Pharma Biotech, told Bioprocess…

March 19, 2019

New clients and Halozyme drive robust Q3 for Avid

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Avid Bioservices has attributed its strong third quarter to the diversification of its customer base and the return of demand from its largest customer Halozyme. When Avid Bioservice became a pure contract development and manufacturing organization (CDMO) in early 2018, it stated the expansion and diversification of its customer base as one of its near-term strategic objectives. A year on and Avid has reported a robust third quarter fiscal year 2019 driven by an increase in the number of manufacturing…

March 19, 2019

Two Form 483s not indicative of systemic manufacturing issues, Biocon

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Biocon has received two US FDA 483s with two and six observations at a drug product plant and an insulin API plant, respectively. The first 483 came following a pre-approval inspection of a new injectable manufacturing line for a biologic drug product at the firm’s site in Bangalore, India conducted between February 7 and 15. The Form has since been published by the US Food and Drug Administration (FDA) and the two observations relate to issues with microbial prevention procedures…

March 15, 2019

Data transfer connection with Amgen part of ‘digital transformation journey’ for GE

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A data transfer connection between GE Healthcare’s raw material manufacturing sites and Amgen’s process development center in Massachusetts will be installed to help improve product efficiencies, performance, and quality. He said GE Healthcare and Amgen mutually decided to come together to form this collaboration, – financials of which have not been divulged. According to Olivier Loeillot, general manager for Bioprocess at GE Healthcare Life Sciences, it will allow GE Healthcare to “digitally track and monitor raw materials in real-time on…

March 15, 2019

Moderna begins making mRNA cancer vaccine from MA plant

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Moderna has successfully transferred personalized cancer vaccine capabilities to its recently opened production facility in Norwood, Massachusetts. In July 2018, Moderna Therapeutics opened a 200,000 square foot clinical development manufacturing plant in Norwood, Massachusetts to support its pipeline of messenger RNA (mRNA) therapies. “Since the site opening, we have successfully manufactured clinical grade mRNA and then moved to formulation and went to filling and finally labeling of our vials,†Stéphane Bancel, Moderna’s CEO told stakeholders during his firm’ recent Q4…

March 15, 2019