INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-2193840525-dna-strand-viral-vector-gene-therapy]( "Key Regulatory Considerations For The Next Wave Of Gene Therapies")
Key Regulatory Considerations For The Next Wave Of Gene TherapiesThe evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.
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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
A Risk-Based Approach To Plasmid DNA And mRNA Process DevelopmentBalancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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![GettyImages-1397047849-circuits-software-blue]( "How To Adopt CSA For Streamlined Computer System Validation")
How To Adopt CSA For Streamlined Computer System ValidationDiscover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.
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![GettyImages-2182859686-glp-1-glucagon-pills]( "Application Of LC-UV/MS Workflows To Increase Efficiency")
Application Of LC-UV/MS Workflows To Increase EfficiencyDiscover how LC-UV/MS workflows help overcome analytical challenges in GLP-1 analog development to streamline impurity identification and boost lab efficiency in research.
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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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Validation Provider Shortens The Path To Equipment Qualification8/19/2025
Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.
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The CHO Toolkit: Flexible Solutions For Complex Molecules9/11/2025
A modular cell line development platform helps overcome biologic complexity. Learn how flexibility and expert support drive success from early development through commercial manufacturing.
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A Rheologist's Guide To Regulatory Confidence10/1/2024
Explore key rheology concepts and terminology, and learn how to generate the required rheological profiles using high-performance instruments.
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Characteristics Of Environmental Residues And Protocols For Removal4/1/2025
Examine disinfectant residue characteristics, impacts, and removal challenges in cleanrooms, as well as learn about the practical requirements for maintaining cleanliness standards and addressing these residues effectively.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-968924932 Industrial engineers with tablet in a factory checking documents]( "The Industrial DataOps Solution For Industry 4.0")
HighByte Intelligence Hub is a DataOps software solution purpose-built for industrial data. The Intelligence Hub enables manufacturers to securely connect, model, condition, and flow valuable industrial data to and from IT systems without writing or maintaining code. The software is deployed at the Edge to merge real-time, transactional, and time-series data into a single payload for consuming applications.
With the Intelligence Hub, users can speed system integration time, rapidly leverage contextualized data for analytics, AI, and ML applications, and govern data standards across the enterprise. HighByte Intelligence Hub provides the critical data infrastructure for Pharma 4.0.
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![GettyImages-1012513082-eye-doctor-eye-drops-drug-development]( "Keep A Close Eye On Quality With Excipients For Drug Formulation")
Developing ophthalmic drugs demands precision and compliance. Explore a specialized excipient portfolio that supports optimal formulation to enhance stability, sterility, and patient comfort.
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![GettyImages-917590578 Code of Federal Regulations (CFR)]( "Electronic Batch Records (EBR) Software For Drug Manufacturing")
Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.
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![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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![Swabs-Bucket]( "Sterile Cleaning Swabs")
With more than thirty unique foam, polyester, and cotton swabs available, our CONSTIX® swabs product line offers a solution to almost any swab application challenge. Every CONSTIX swab has been designed with different lengths, head sizes, and materials to meet very specific customer needs.
