Search results for "Sustainability"
Article
Taking a “Development-by-Design” Approach to Cell Therapies
The goal is to provide high quality and sustainability,” he says. Removing manual operations and human error from the process will be crucial.
Invetech has been working on cell therapy process sca…
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Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…
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Life cycle assessment of the protein A process in mAb manufacturing
…its material origin to its end-of-life deposition, is a common method for quantifying environmental sustainability.
Here we present a cradle-to-grave LCA for protein A chromatography resins in the…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
Article
Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
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State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
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Report from the 12th Plasma Product Biotechnology Forum
When questioned on what other areas relevant to plasma biotherapeutics they would like to see, some responses given were:
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Sustainability
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Artificial Intelligence (AI)…
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Assessing Manufacturing Process Robustness
This article proposes an independent structured assessment process that uses data to develop insights into product sustainability and risks. It focuses on the evaluation of intra- and inter-batch vari…
Article
The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
By Jim Miller
A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…
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The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…