Tuesday, December 14, 2021 Daily Archives

Pathogen Safety Digital Platform for Biopharmaceuticals: The Journey from Ground to Cloud

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Digital transformation is at the heart of many biopharmaceutical companies’ strategies for ongoing success. However, the definition of digital transformation and what it consists of differ within the bioprocess industry (and might even vary within a single company), specifically as it applies to the overall value chain from R&D to clinical trials, manufacturing, supply chain, and eventually commercial operations. To provide a perspective on what digital transformation could look like in bioprocessing, we present a case study about an exploratory…

December 14, 2021

Automated Process Control Based on In Situ Measured Glucose Concentration

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A process analytical technology (PAT) strategy involves defining critical process parameters (CPPs) of a biomanufacturing process that influence critical quality attributes (CQAs) and controlling those CPPs within defined limits. Doing that enables consistent product quality and helps companies reduce waste and costs. Glucose is an important CPP in bioprocessing and cell therapy. Glucose often is fed as a bolus addition based on daily off-line measurements, but that can lead to high glucose fluctuations and to excessive glucose feeding, which can…

December 14, 2021

Realization of Quality By Design and Beyond: The Intelligent Cell Processing System

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Cells are used as raw materials, intermediates, and final products in biopharmaceutical and cell therapy manufacturing. Because living cells are always in a dynamic state, their characteristics must be kept within specified ranges throughout bioprocessing to preserve their utility. Cell population expansion without changing the original cell properties is key for obtaining the required number of cells at the next step. However, limited process data are collected during the expansion phase — information that could be used to understand and…

December 14, 2021

Novo Nordisk forks out $2.5bn to expand Denmark plant

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Novo Nordisk will invest $2.5 billion to construct three manufacturing facilities and expand its Kalundborg, Denmark site. According to Danish drugmaker Novo Nordisk, the expansion will support production of Novo Nordisk’s current and future injectable and oral products, including insulin. A spokesperson for Novo Nordisk told BioProcess Insider its Kalundborg site has been selected because the firm has “more than 50 years’ experience out of Kalundborg in Denmark; about 50 % of the total insulin production comes from Kalundborg; we…

December 14, 2021

Bora Pharmaceuticals enters partnership to expand CDMO presence

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Bora Pharmaceuticals has partnered with Taishin Healthcare Limited, where both parties will jointly invest $108 million to strengthen CDMO offering. Bora says it will expand its footprint in the contract development manufacturing organization (CDMO) space by deploying private equity funds and its own resources. In addition to the partnership, Bora looks to move into the macromolecular and cell and gene therapy (CGT) manufacturing sector, and by making this step, the firm claims it will strengthen its global competitiveness and drive…

December 14, 2021