Search results for "quality" in Articles / App Notes
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx.
Early biotechnology products in th…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
…44 - The impact of filing accelerated review applications on process development
11:41 - What quality teams should do to ensure quality standards are maintained in the absence of traditional re…
Article
Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
Article
Design and Qualification of Single-Use Systems
…be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications” (2-4…
Article
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 …
Article
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, …
Article
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…
Article
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…
Article
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…