Search results for " drug"
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Applying GMPs to the BioPharma Supply Chain
The drugs produced must be available when needed, effective for their intended purpose, and safe to use. At an operational level, it is vital that biopharmaceutical production is carefully controlled …
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Bureaucratic Roadblocks Threaten Biopharma Growth
…reased data requirements, and Canada’s increased utility requirements all ultimately undermine the drug development and patenting process and may impede the delivery of novel medicines to market.
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Raw Material Variability
The biological molecule is often thought of as the value-adding element of drug substance, but unless the variability of each and every material that the cells come into contact during their creation …
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Outsourcing Trends in Biopharmaceutical Manufacturing
In this context, it is the additional strategic benefits, beyond just cost savings, that outsourcing can bring to drug development and manufacture that often swing decisions.
Those benefits must b…
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Brazil Emerges as Global Biopharm Collaborator
Such measures have traditionally been used for vaccines and most recently for synthetic drugs as well as biopharmaceutical products.
Future growth
The global financial crisis, which starte…
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Trends in Downstream Bioprocessing
As titers have increased, new technology and the realization that most drugs will not require metric tons of product have reduced the perception of a downstream bottleneck.
So what activities have…
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State of Quality and Compliance in the Biopharmaceutical Industry
Pipelines
The pharmaceutical industry is not producing the blockbuster drugs of the past. Stakeholders are more demanding as healthcare costs continue to skyrocket. Patients are becoming more i…
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Essentials in Establishing and Using Design Space
Generally across multiple-unit operations, experiments are more representative of the entire process the drug product or substance will experience.
Risk assessments
Risk assessments …
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The Development and Application of a Monoclonal Antibody Purification Platform
In addition, we must develop new technologies for ultrafiltration to meet the need for high-concentration drugs used for subcutaneous injection. These are just some of the challenges facing the indust…