Search results for " biopharmaceuticals"
Article
Improving PAT for Biologics
Advances in high-throughput systems, Raman and near-infrared (NIR) spectroscopy, high-performance single-use sensors, and chemometric methods are also helping manufacturers of biopharmaceuticals overc…
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Pharma Investments Reflect Key Industry Trends
“While demand has increased for biopharmaceuticals, it has not kept pace with the 10-fold increase in productivity,” states Günter Jagschies, senior director of strategic customer relations for BioPro…
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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Digitalization: The Route to Biopharma 4.0
Perfusion Cell Culture Processes for Biopharmaceuticals: Process Development, Design, and Scale-up; Cambridge University Press, 2020. DOI: 10.1017/9781108847209
6. Hutter, S.; Villiger, T. K.; B…
Article
Reimagining Affordable Biosimilars
Berkowitz, “Biophysical Characterization and its Role in the Biopharmaceutical Industry,” In Biophysical Characterization of Proteins in Developing Biopharmaceuticals, D.J. Houde and S.A. Berkowitz Ed…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Avoid shortcuts and inflexibility
Residual impurity testing for biopharmaceuticals is complicated and time-consuming, even when risk-based strategies are employed. Short cuts should be avoide…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options. …
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…