INSIGHTS ON QUALITY CONTROL
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A Guide To Scale-Up And Purification For Small, Large Molecules
Advance your separation and purification strategies by leveraging modern industrial chromatography approaches that scale reliably from lab to production across small-molecule and biologics manufacturing.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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The Future Of QC Is Now
Pharma Industry 4.0 is reaching microbiological quality control. See how automation and digital workflows are transforming manual QC processes, improving productivity, and reliability.
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Science With Purpose: Advancing Sustainability In Biopharma Testing
Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.
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Your Digital QC Companion For Sterility Testing8/13/2024
Discover software designed to ensure fully accurate data recording in sterility testing and that complies with 21 CFR Part 11 standards for electronic records and signatures.
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Understanding cGMPs For Phase 1 Investigational Drugs8/15/2025
Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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Detection Of Food Spoilage Organisms3/5/2026
Membrane filtration offers a faster, more precise approach to detecting spoilage organisms. See how its flexibility and accuracy make it a valuable tool for improving food microbiology processes.
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Leveraging A Modern HPLC System For Peptide Drug Substances Analysis8/22/2024
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
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Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications6/19/2025
Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.
QUALITY CONTROL SOLUTIONS
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The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
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Mikart’s analytical services begin with accurate measurements of formulation characteristics and are informed by our dedicated team’s mastery of process — the precise changes that maximize your product’s performance and market adoption.
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Partner with a trusted, globally proven CDMO whose world-class, rapidly scalable facilities and unwavering commitment to quality help accelerate patient access to life-saving biologics.
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The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
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Discover a system that addresses the issues faced by Quality Control (QC) labs with first-time quality (FTQ) results, shortened release cycles, and fewer investigations.