Search results for " compliance"
Article
Cell-free Expression Systems Pose Cell Culture Alternative
…e extracts and products at scale as well as having several products in clinical trials for which GMP compliance has been demonstrated, the professors state. Meanwhile, LenioBio, a Germany-based biote…
Article
Developing a New Biologic Drug: Regulatory Challenges and Considerations
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Key milestones and planning ahead for compliance when bringing a new biologic drug to market
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Traceability in Western Blot Imaging: Considerations for GxP
In regulated environments, electronic record-keeping can improve both traceability and efficiency – but compliance with regulations like Code of Federal Regulations Part 11 and European Union GMP Anne…
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How To Execute Successful Data Migrations
…n project delays, cost overruns, lack of delivery, and bad data that compromise system integrity and compliance. Insufficient planning often stems from the failure to view data migration efforts as d…
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Reimagining Affordable Biosimilars
Geigert, “Complex Process-Related Impurity Profiles,” In The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Springer, Cham, Switzerland, 3rd ed., 2019), pp. 231-260
J. Gokemeije…
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Improving Upstream Predictability
“Finding the right balance between functions, compliance, and affordability will likely include new designs and procedural controls,” he says. Traditional quality control (QC) methods will also become…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
…vely more so; the issues in many countries involve compulsory licensing, anti-evergreening laws, and compliance with the General Agreement on Tariffs and Trade and Trade Aspects of Intellectual Prope…
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Faster Flavivirus Vaccine Production
This is valuable both for regulatory compliance and future drug development.
Read the article and access the white paper here
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Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
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Nurturing Knowledge from Disparate Data Streams
Pharmaceutical scientists must be able to integrate and interpret these data in an efficient manner that ensures reliability, security, and regulatory compliance.
Digitalization creates difficulti…