INSIGHTS ON QUALITY ASSURANCE
-
Improving Therapeutic Protein Efficacy Through Charge Profile Adjustment
By adequately measuring charge variants early in development and implementing effective control strategies, developers can mitigate risks and ensure the safety and efficacy of their mAb products.
-
Accelerate Review Times And Deliver Better Quality Documents
Discover expert strategies to streamline your document review process with Diahann Homer and Kelly Spencer to boost quality, reduce cycles, and ensure compliance in medical writing.
-
Ethylene Oxide For Industrial Sterilization: Part 1
Understanding EO sterilization requires careful control of cycle variables and strict safety protocols. Learn how evolving standards and best practices ensure both effective sterilization and compliance.
-
Three Tips To Put Your Viral Vector On The Path To Regulatory Success
Gene therapy regulations are evolving fast, creating uncertainty for developers. Discover three strategies to navigate approval challenges and keep pace with changing expectations.
-
Aggregate Analysis Of Tirzepatide12/11/2025
A new size exclusion method effectively analyzes Tirzepatide aggregates, demonstrating robust separation and reproducibility with minimal need for organic solvents or acidic modifiers.
-
Understanding The FDA Recall Risks And Solutions For Life Sciences Manufacturers11/5/2024
Investigate the factors contributing to FDA recalls, the effects on both consumers and businesses, and how integrated digital solutions can play a crucial role in preventing such incidents.
-
Doubling Up For Speed In Biomanufacturing12/12/2025
Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.
-
Handling Protocols: Key Considerations In The Highly Potent API Market5/12/2025
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
-
Digitalization In The Pharma Industry1/20/2026
Digitalization is reshaping pharmaceutical manufacturing. Discover how advanced technologies like the digital twin accelerate innovation and improve outcomes for patients worldwide.
QUALITY ASSURANCE SOLUTIONS
-
Observe the viability of your cells with the field-upgradeable cellular imaging option for the SpectraMax i3/i3x Multi-mode Detection Platform.
-
Automate research and clinical workflows with intuitive setup, fewer errors, and optimized instrument use that supports regulated environments and delivers personalized service.
-
Legacy paper trails are a compliance nightmare.
Missing documents, illegible handwriting, and inconsistent data leave you scrambling and vulnerable during audits. Digital CQV captures data and objective evidence in real time, ensuring a crystal-clear audit trail with time-stamped entries and electronic signatures that meet 21 CFR Part 11 requirements.
-
MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable.
-
PMS is here to help with all your cleanroom contamination needs.