Friday, March 29, 2019 Daily Archives

Development of Affinity Chromatography Adsorbents for Bioseparations

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This webcast features: Patrick Gurgel, Head of Research & Development, Prometic Bioseparations. Affinity chromatography has a long history of use in bioprocesses and is a powerful tool in making industrial processes more efficient by reducing the number of steps necessary to achieve the desired target purity and yield. It is common, however, for teams to only consider affinity chromatography as an alternative once other options have been considered, evaluated, and discarded, which translates into a need to develop affinity adsorbents…

March 29, 2019

Biocon: One eye on biologics IPO to support blossoming biosimilars

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Managing director Kiran Mazumdar-Shaw has told Indian news outlets Biocon could spin-out its biologics division to raise funds for further biosimilar development. Biocon is Indian’s largest pharmaceutical firm with a portfolio of small molecule and branded formulation products. But the Indian drugmaker has also begun to make its mark on the international biosimilars market with commercialization partner Mylan launching various products in both the US and European markets. Ogivri became the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved…

March 29, 2019

bluebird opens gene therapy plant as EMA backs gene therapy

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The EMA has recommended approving Zynteglo, bluebird bio’s one-off treatment for beta-thalassaemia. Meanwhile the cell and gene therapy firm has cut the ribbon on a 125,000-square-foot facility in Durham, North Carolina. The EMA’s Committee for Advanced Therapies (CAT) recommended Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – also know as LentiGlobin – today, paving the way for bluebird bio to bring its gene therapy product to market. The product uses a lentiviral viral vector to add functional copies of a…

March 29, 2019

AbbVie slashes 178 Stemcentrx jobs in California

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AbbVie will reduce the workforce at a facility run by its acquisition Stemcentrx months after halting enrollment a Phase III trial for lead candidate Rova-T. In 2016, AbbVie acquired Stemcentrx for approximately $5.8 billion (€5.2 billion), bolstering its oncology pipeline with the addition of late-stage asset rovalpituzumab tesirine (Rova-T) in trials for small cell lung cancer (SCLC). But this month, AbbVie announced plans to cut jobs at Stemcentrx site in South San Francisco through a Californian Worker Adjustment and Retraining…

March 29, 2019

Monoclonal Antibodies: Beyond the Platform in Manufacturing

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The vast majority of monoclonal antibody (MAb) production processes are based on fed-batch Chinese hamster ovary (CHO) cell culture and protein A affinity column chromatography capture. Increasing cost-consciousness — among innovator companies as well as biosimilar makers — has many companies looking “beyond the platform†for less expensive alternatives that may provide better results. Here the BPI editors review some state-of-the-art alternatives in upstream and downstream MAb drug substance bioprocessing as well as drug-product manufacturing. The current “gold standard†platform…

March 29, 2019