Search results for " Biopharm" in Articles / App Notes
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Making the Move to Continuous Chromatography
…roducing different process intensification initiatives, there is still, to my knowledge, no approved biopharmaceutical product with a continuous chromatography step, and some aspects/questions in the…
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Understanding Validation and Technical Transfer, Part I
Subsequent revisions to US and international regulations and guidance documents stressed the need for process validation and quality management systems to ensure pharmaceuticals and biopharmaceuticals…
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Modern Manufacturing Key to More Effective Vaccines
He said these developments will “transform the biopharmaceutical industry” by boosting local production and supply of high-quality vaccines in developing countries, while also expanding capacity for r…
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Industry Adoption of Single-Use Systems Remains Low
Conservative attitude
Conservative attitudes tend to dominate the pharmaceutical and biopharmaceutical industries, which have traditionally resulted in slow adoption of newer manufacturing tec…
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
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Preclinical Evaluation of Product Related Impurities and Variants
In this 38th article in the “Elements of Biopharmaceutical Production” series, the authors focus on the approaches for sample preparation of preclinical evaluation of safety and efficacy taking into c…
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Process Development: What May Lie Ahead in 2018?
What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engineers? Here, we look at some of the most popular Process Development Forum articles …
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What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
…
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Transformative Medicines Challenge FDA and Manufacturers
The situation puts a premium on efforts by FDA and biopharma companies to identify efficiencies and improved methods for testing and producing cutting-edge medical technologies. It also highlights the…
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QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…