Remove topic manufacturing-equipment-downstream-processing
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Why QbD and Digitalization Are Foundations for Cell Therapies

ISPE

Later in my career, I started to realize and apply myself to the many gaps that exist between the initial R&D of treatments and how to scale them in manufacturing to bring these products to patients. I focus my work to improve the required methods, equipment, and systems for our emerging industry to scale to meet our vision.

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USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics

ISPE

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. 1 Some advantages are apparent based on the nature of a continuous processing, including higher efficiency at lower cost.

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2022 ISPE Biotechnology Conference: Ongoing Growth & Development

ISPE

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. The Road to Advanced Manufacturing.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP).

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 7 An integrative (vs. 7 An integrative (vs.