Friday, March 22, 2019 Daily Archives

Emerging Tools for Exosome Purification and In-Process Monitoring

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This eBook introduces new analytical approaches that enable in-line chromatographic detection of exosomes. One approach can discriminate extracellular vesicles from nonvesicle contaminants, and one potentially can discriminate exosomes from other vesicles. Examples illustrate how they enable development of more effective and better documented purification methods. The special qualifications of monolithic chromatography media for exosome purification are discussed. New process tools designed to accommodate some of the special challenges of exosome purification are introduced. Exosomes represent one of several species of…

March 22, 2019

Breaking the Big 4: How Takeda is taking on vaccines

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While vaccines will continue to be dominated by GSK, Merck, Pfizer, and Sanofi, manufacturing and collaborations can help to unblock this consolidated industry says recent entrant Takeda. Rahul Singhyi, COO of Takeda vaccines, told delegates at the BPI West event in Santa Clara, California that vaccines used to be viewed as “the backwaters of the pharma industry, largely considered part of corporate social responsibility,†but that has changed over the past 20 years due to innovations and approvals in disease…

March 22, 2019

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

Shanghai center aims to accelerate cell and gene therapy development

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The ATLATL-MACS Center will support biotech firms in the burgeoning cell and gene therapy space and will include access to Miltenyi automated CAR-T preparation instruments. Having spent a year under construction, ATLATL-MACS Center opened this week. The center is a collaboration between ATLATL Innovation Cluster (AIC) – a Chinese innovation support firm offering lab space as a service – and cell and gene therapy vendor Miltenyi Biotec aimed at supporting the growing research in innovative and personalized medicines. ATLATL and…

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