Search results for " industry"
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Securing the Single-Use Supply Chain
After further consideration of the issues surrounding the supply of single-use systems, however, many in the industry believe that dual sourcing presents many challenges that can often be avoided by t…
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Sterilization Trends for Single-Use Consumables
He does point out, though, that there is a long history of EtO use in the medical device industry, with rich supporting data packages.
“While there have been some incidents with EtO that have caus…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Bioreactors designs
Historically, STRs were adapted from the chemical industry to fit the needs of first the brewing and then the biopharmaceutical industry in order to enable the affordable indus…
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The New World of Biopharmaceutical Manufacturing
…; and Eva Heintz, global market manager, Healthcare, at Solvay Specialty Polymers about advances the industry has made and the challenges that remain.
Single-use technologies
PharmTec…
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Trends in Downstream Bioprocessing
Indeed, a survey conducted in late 2012 among 450 global subject matter experts and senior participants who make up BioPlan’s Biotechnology Industry Council confirmed that a leading 24% of bioprocessi…
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Moving PAT from Concept to Reality
Still on the learning curve
The biopharmaceutical industry and regulatory agencies have recognized the value of PAT. Although many large multinational manufacturers have adopted and implemented va…
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Continuous Processing for the Production of Biopharmaceuticals
With the growing demand for biosimilars and an ever-increasing pressure for reduction in manufacturing costs, the biotech industry seems to exhibit a flourishing interest in the development of continu…
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Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
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Modern Manufacturing Systems Key to FDA Quality Initiative
To support real change, FDA’s Center for Drug Evaluation and Research (CDER) has launched a full-court press to convince industry of the value of adopting modern drug manufacturing systems. The agency…
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Setting Standards for Biotech Therapeutics in India
35-40
The past decade has seen considerable growth in the Indian pharmaceutical industry. India has emerged as a key supplier of high quality and affordable medicines not only to the developing w…