Search results for "quality"
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Platform Approach Speeds Process Development
At Boehringer Ingelheim (BI), advances have enabled higher performance benchmarks in time and resources for process development with stringent product quality requirements. An expression platform has …
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GMP Challenges for Advanced Therapy Medicinal Products
In particular, they often do not have adequate systems in place for evaluating the quality of starting and raw materials, which is a vital necessity in the production of advanced, usually biological, …
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Biopharma Advances Demand Specialized Expertise
…anufacturing processes?
McNally (PPD Consulting): FDA established a new Office of Pharmaceutical Quality in 2014, which we anticipate will have major impacts on the biopharmaceutical development a…
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Labeling of Biosimilars
In December 2014, guidelines on quality standards for biosimilars with proteins as an active substance came into effect (1), while guidance on clinical and non-clinical issues with the products was be…
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Monitoring and Control of Inline Dilution Processes
An effective evaluation will include investigation of the total cost of ownership, including space requirements, future expansion plans, labor costs, and quality control, among other factors. “I…
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Efforts Accelerate to Streamline Postapproval Change Process
…ine after a drug comes to market to improve products and systems and ensure reliable supply of high-quality drugs and biologics that meet regulatory standards. With more breakthrough and critical the…
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Continued Process Verification for Biopharma Manufacturing
What is Continued Process Verification?
CPV is fundamentally a formal means by which the performance of a commercial manufacturing process is monitored to ensure consistently acceptable product qu…
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Reimagining Affordable Biosimilars
For biosimilars, factors that significantly impact affordability and development time include: development cost, variability in product quality, and low success rates of trials.
Cost of biosimil…
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Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…
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Managing Risk in Raw Material Sourcing
IPEC has developed standardized templates and materials to help simplify supplier evaluation and auditing, as well as the development of quality agreements, and to ensure consistency. Having additiona…