GEN-MKT-18-7897-A
Jan 18, 2024 | Biopharma, Blogs, Clinical, Environmental / Industrial, Food / Beverage, Forensic, Life Science Research, Pharma, Technology | 0 comments
Read Time: 5 minutes
Unplanned downtime is a formidable adversary that businesses across various industries strive to minimize. Defined as the unexpected interruption of regular operations, unplanned downtime can wreak havoc on productivity, profitability and customer satisfaction. In this article, we delve into the causes of unplanned downtime, its far-reaching consequences and strategies to mitigate its impact.
Causes
Consequences
Mitigation strategies
Conclusion
Unplanned downtime remains a persistent challenge for businesses but with strategic planning and proactive measures, its impact can be significantly reduced. From embracing advanced technologies for predictive maintenance to fortifying cybersecurity defences, organizations must prioritize resilience to safeguard their operations, reputation and bottom line.
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As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
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