Search results for "biotech"
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Most major and mid-size biotech companies know what QbD means and how to go about implementing it and have already incorporated most of the QbD concepts into their approaches towards process and produ…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical and biotechnology companies making products for human use have an obligation to ensure that their products are safe, effective, meet established regulatory expectations and licenses, an…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Overall process scalability and robustness, says Todd Sanderson, senior R&D manager for Pall Biotech, are dependent on the performance of the bioreactor whether it is adherent- or suspension-based. “T…
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Can Vaccine Development Be Safely Accelerated?
The biotech was the first to advance a vaccine (INO-4700) against MERS-CoV into human testing and is currently preparing to initiate a Phase II trial for INO-4700 in the Middle East. This vaccine, how…
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Improving Upstream Predictability
By Agnes Shanley
In the earliest days of biotech, developers often struggled to sustain conditions that would optimize cell health and product yield. Today, better understanding of cells and …
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Moving PAT from Concept to Reality
… potential is not yet being used,” agrees Svea Grieb, product manager for PAT at Sartorius Stedim Biotech.
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors n…
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What’s New in Upstream Technologies
Integrated online biomass measurement
Sartorius Stedim Biotech (SSB) added an integrated online biomass measurement to its ambr 15 fermentation and ambr 250 high throughput systems for microbial a…
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Industry Adoption of Single-Use Systems Remains Low
In a similar move, Sartorius Stedim Biotech entered into a deal in January 2018 to equip Abzena’s two integrated contract development and manufacturing organization (CDMO) facilities in Bristol, PA, a…
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Innovative Therapies Require Modern Manufacturing Systems
Legislative action further made permanent the federal R&D tax credit, a long-sought change expected to boost private sector investment in biotech companies. Medical device makers gained a two-year del…
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Modular Manufacturing Platforms for Biologics
…the right scale or utilize the appropriate technology to address the current business needs of many biotech manufacturers,” says Emel, who points out that most biotech companies are focusing on speci…