INSIGHTS ON QUALITY CONTROL
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Leadership Perspectives From The Grand Opening of Flamma's Honkai 2 Facility
A two-day celebration in Dalian highlighted a major global investment milestone, featuring leadership perspectives, opening ceremonies, and the strategic vision behind expanded cGMP manufacturing capabilities.
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Tackling Residual DNA Testing In Biotherapy Manufacturing
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
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Human Performance In Pharma: Strengthening The Biotech Workforce
Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.
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Leachables Method Development, Validation And Relevant ICH References
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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Practical Solutions For Protein Analytics And Residual DNA Testing11/12/2025
Discover practical solutions for common quality control bottlenecks in biotherapy manufacturing. Learn how to improve protein analytics and DNA testing robustness and accelerate time to market.
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Cloud Migration In Regulated Environments: Validation Implications And Best Practices3/27/2026
Cloud adoption is essential for BioPharma growth, offering scalable tools for faster research. Success requires a risk-based approach to ensure data integrity and GxP compliance during the shift.
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Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance7/28/2025
Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.
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Secondary Packaging: Inspection, Brite Stock Bottle Labeling, And Cartoning6/23/2026
Gain insight into a coordinated, around-the-clock approach that demonstrates how packaging efficiency can keep pace with urgent pharmaceutical launches and tight commercialization timelines.
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Particle Data Collection And Interpretation For ISO Cleanrooms3/19/2026
Transition from periodic sampling to continuous monitoring. Learn to establish risk-based alert limits and use N:M trending to maintain a true state of control in critical cleanroom zones.
QUALITY CONTROL SOLUTIONS
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As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.
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The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
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Maintain a Grade-A environment for sterile fill-finish with a dual-pressure aseptic isolator. Accelerate campaign turnarounds using integrated vaporized hydrogen peroxide.
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Active bead release gives manufacturers precise control over T cell isolation timing, phenotype preservation, and workflow efficiency, eliminating multi-day passive dissociation delays.
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Safeguard your cleanroom environment with secure material transfer solutions. Interlocking pass boxes prevent cross-contamination and maintain critical sterility during item transit.