Search results for " biopharms" in Articles / App Notes
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Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
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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
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
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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
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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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…
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Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…