INSIGHTS ON QUALITY ASSURANCE
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Ringing The Alarm: Unified Data For GMP Annex 1 Compliance
Alarm monitoring can be more than compliance. Learn how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.
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End-To-End Workflow Integration For Antibody Development
Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.
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What Is Size Exclusion Chromatography (SEC)?
Aggregation can compromise mAb quality at many stages of development. Learn why size exclusion chromatography is a trusted approach for detecting aggregates and supporting confident characterization.
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Validating VH2O2 Decontamination Cycles For Product And Personnel Safety
Discover how ultra-sensitive spectroscopy transforms decontamination validation, revealing hidden efficiencies that safely cut facility downtime while ensuring absolute safety.
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What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)?7/20/2026
Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.
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Raw Material Considerations For Cell Therapies6/16/2025
For cell therapy developers, selecting appropriate raw materials is a significant challenge. Examine key considerations for mitigating risk and aligning with current regulatory expectations.
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What Does Annex 1 Mean For Cryovial Filling?10/6/2025
New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.
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Regular Performance Checks To Detect Contaminants3/19/2026
Regular performance checks validate that critical control points detect contaminants and reject affected product. Gain insight into how guided on-screen testing ensures compliance and reliability.
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Ensuring Quality, Driving Customer Confidence7/15/2025
How does quality assurance help drive scientific progress? A 30-year veteran shares her story of supporting customer needs and the development of groundbreaking new therapeutics.
QUALITY ASSURANCE SOLUTIONS
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As the time, costs and complexity of cleaning validation challenges grow, savvy life sciences companies are building a competitive advantage around smarter approaches to cleaning validation.
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Our solutions have been specified in the testing process for the top two GLP-1 manufacturers
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Flexible lab equipment services covering maintenance, repair, qualification, and validation to improve reliability, compliance, and operational efficiency.
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AGLTS 2 is the brand new fully automatic GMP compliant Glove Leak Tester for Pharmaceutical Isolators and RABS in the pharmaceutical industry, developed referring to the Positive Pressure Decay Method which follows the international standard ISO 14644-7 Annex E.5.
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Accelerate your gene therapy manufacturing with the Xcellerex™ X-platform – a next-generation single-use bioreactor system designed for viral vector workflows.