Search results for "manufacturing" in Articles / App Notes
Article
Applying GMPs to the BioPharma Supply Chain
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be available when needed, effective for their intended purpose, and safe to use. At an operational level, it is v…
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Improving Upstream Predictability
Some of the most significant gains have been made in cell line expression, advanced sensors, and automation, says Atul Mohindra, R&D director for biomanufacturing at Lonza Pharma and Biotech. “Using a…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Nesta
Abstract
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody sol…
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GMP Challenges for Advanced Therapy Medicinal Products
They lack the regulatory expertise and resources to establish and operate GMP-compliant manufacturing processes. In particular, they often do not have adequate systems in place for evaluating the qual…
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Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
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Advancing QbD in the EU
In addition, EU authorities are becoming more concerned about the increasing number of quality defects in pharmaceutical manufacturing that have been causing a rise in drug scarcities.
ICH GUID…
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Using Digital Twins to Model Process Chromatography
By Jennifer Markarian
A digital twin is a model of a process that allows process development experiments to be run in silico—on a computer—rather than on actual lab or manufacturing equipment. Alt…
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Process Development: 2020 Reflections and 2021 Possibilities
Spotlight on Vaccines and Viral Vectors
At the forefront of many minds in 2020 going into 2021 is vaccine development and manufacturing. Among the many vaccine challenges in relation to the urgenc…
Article
Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
13, 2020, Cytiva, announced that it is investing $500 million over five years to expand its global manufacturing capacity. The company will also hire nearly 1000 personnel in key areas as part of its …
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By Claire Hill
The biopharmaceutical market continues to expand at a rapid pace and the demand for upstream manufacturing capacity, particularly for growth areas such as viral vectors, is growing …