Search results for "biopharm"
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Historically, in biopharmaceutical development, criticality has been a frequently arbitrary categorization between important high-risk attributes or parameters and those that carry little or no risk. …
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Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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Biotechnology Innovation and Growth in Israel
Israel is also ranked second to the United States in biopharmaceutical patents per capita, and its pharmaceutical market was estimated at US$1.78 billion in 2010 and is expected to reach US$2.3 billio…
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Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …
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Bioprocessing Advances in Vaccine Manufacture
Single-Use Adoption
BioPlan's 10th Annual Report documents increasing adoption of these technologies and their impact on biopharmaceutical manufacturers. Survey data show that bioprocessing at pre…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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Trends in Downstream Bioprocessing
DSP remains one of the most crucial and talked-about areas of biopharmaceutical manufacturing. Indeed, a survey conducted in late 2012 among 450 global subject matter experts and senior participants w…
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State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
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FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
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Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…