Author Archives: Ben Hargreaves

WuXi AppTec absorbs Oxgene to expand cell and gene services

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WuXi AppTec acquires its first facility in Europe as part of deal that adds manufacturing systems and contract researching tools. As part of the acquisition, Oxgene will become a subsidiary of WuXi Advanced Therapies (WuXi ATU), which is WuXi AppTec’s cell and gene therapy contract testing, development and manufacturing organization. Oxgene, which will retain its name, is a contract research and development organization based in Oxford, UK, that provides cell and gene therapy discovery and biomanufacturing platforms. The company offers…

March 4, 2021

Ensoma launches to deliver ‘off-the-shelf’ genomic medicine

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Ensoma emerges with Series A funding and a collaboration deal with Takeda for its vector-delivered treatments. Ensoma was backed in its Series A financing by 5AM Ventures and Takeda, amongst other investors, with $70 million (€57 million). Takeda’s investment occurs alongside an exclusive worldwide license to develop Ensoma’s ‘Engenious’ vectors for up to five rare disease indications. The agreement includes a potential $100 million investment in upfront and preclinical research payments. Should the candidates progress past the preclinical stage, Ensoma…

February 22, 2021

Biogen acknowledges risk on manufacturing provisions for aducanumab

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Biogen says ‘significant capacity’ allocated to aducanumab could impact 2021 results if the potential Alzheimer’s disease treatment is not approved. At the end of last month, Biogen announced that the US Food and Drug Administration (FDA) would delay its decision on aducanumab by three months, meaning that a decision is now expected on approval by 7 June of this year. The monoclonal antibody (mAb) treatment could become the first therapy approved for Alzheimer’s disease to change the course of the…

February 9, 2021

Roche hit for $6.3bn due to biosimilar competition

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Roche outlines ‘higher than originally expected’ sales impact from biosimilars worldwide. Roche announced in full year results for 2020 that biosimilars to Herceptin (trastuzumab), Avastin (bevacizumab), and MabThera/Rituxan (rituximab) dented sales by CHF 5.7 billion ($6.34 billion) worldwide. Roche group’s CEO, Severin Schwan, commented in an investor call after the results were revealed that “the impact of biosimilars was significant, somewhat higher than we originally expected.†As a result, sales in the company’s pharmaceuticals division decreased by 8% to CHF…

February 8, 2021

Novartis offers Swiss facility support for Pfizer vaccine manufacture

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The deal is the first of potentially ‘multiple’ such agreements to support manufacture of COVID-19 vaccines. The agreement sees Novartis provide aseptic manufacturing services from its Stein, Switzerland, facility for the production of Pfizer and BioNTech’s COVID-19 vaccine. Novartis will provide the services under a contract manufacturing agreement that sees the company take bulk mRNA active ingredient from BioNTech and fill this into vials, before shipping the vials back to BioNTech for distribution. The Swiss company announced that it would…

February 2, 2021

Navigating COVID with supply chain ‘war room’ and digital tech

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Samsung Biologics says virtual capabilities and supply chain management led to a successful year, despite the global pandemic. John Rim, the newly appointed president and CEO of Samsung Biologics, used a presentation at the JP Morgan Healthcare Conference to reveal that the company had signed $1.7 billion (€1.4billion) in contracts during 2021, a record for the company. Explaining how the company had managed to achieve this, Rim called attention to Samsung Biologics’ capacity for virtual exhibition halls and live-streaming tours.…

January 26, 2021

Cognate pushes on with global expansion project despite COVID

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Cognate plans to increase capacity in Europe four-fold and to double existing capacity at its US site. This time last year, Cognate Bioservices completed the acquisition of Cobra Biologics, adding its plasmid and viral vector manufacturing capabilities to its own cell therapy services. Cognate began this year with another announcement, it would be adding to its subsidiary’s manufacturing capacity through an investment in Europe, alongside bolstering its existing facilities in the US. The European expansion will see Cobra quadruple capacity…

January 19, 2021

Joint venture promises to reduce manufacturing cost of cell and gene

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Three organizations have created ScaleReady to provide a ‘cost-effective’ cell and gene production platform. The joint venture combines the capabilities of Bio-Techne, Fresenius Kabi, and Wilson Wolf, which each take an equal share in the newly created business. ScaleReady will offer technologies for cell culture, cell activation, gene editing and cell processing developed separately by these companies. The joint venture business itself will provide the sales, marketing, and application support for the cell and gene therapy manufacturing platform created by…

January 18, 2021

Plan to make 1.3bn vaccines in 2021 places strain on Pfizer’s production network

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Pfizer is focusing on building out an inventory of existing products to concentrate on vaccine production in 2021, the firm says. Pfizer and BioNTech’s mRNA-based COVID-19 vaccine was approved by the European Commission on 21 December, joining previous approvals in the US and the UK, as the partners prepare their commercial manufacturing capacity. Pfizer reduced estimates regarding the number of vaccines it would be able to produce in 2020 from 100 million to 50 million in November. For 2021, the…

January 4, 2021

UK advanced therapy sector employment in line to double by 2024

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The UK aims to grow its cell and gene therapy workforce with both a training network and by recruiting from outside the sector. According to Cell and Gene Therapy Catapult (CGTC)’s research, 83% of companies operating in the advanced therapy sector stated that a lack of skilled employees will be one of the main issues that slows down or causes a delay to their forecasted expansions. CGTC projects that the workforce in the industry will need to double from approximately…

January 4, 2021