Key Manufacturers: Waters, Agilent, Thermo Fisher Scientific, Shimadzu
Category: Chromatography Systems
HPLC / UPLC Instrumentation
High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC/UHPLC) are the gold-standard techniques for separating, identifying, and quantifying components in liquid mixtures. While traditional HPLC systems typically operate at pressures up to 400–600 bar using 3–5 µm particle columns, modern UPLC/UHPLC systems utilize sub-2 µm particles and pressures exceeding 1,000 bar (up to 15,000 psi) to achieve superior resolution, sensitivity, and drastically reduced run times.
Official Websites & Resources
- The Waters Performance UHPLC/UPLC systems (www.waters.com)
- Thermo Scientific Vanquish HPLC & UHPLC Systems (www.thermofisher.com)
- Shimadzu Nexera Series (www.ssi.shimadzu.com)
- Agilent HPLC and UHPLC Instruments (www.agilent.com)
Associated Analytical Procedures
Context in Practice: Example Specifications
From: Typical AAV Drug Product Specifications
This instrument is used in the context of measuring the Quality Attribute Capsid Empty/Full Ratio with the following details:
- Purpose / Rationale: A key purity and potency attribute, as only full capsids are therapeutically active.
- Typical Acceptance Criteria: The specification is product-specific and justified by clinical and manufacturing data. It is typically set as a minimum percentage of full capsids (e.g., NLT 25%) or a maximum percentage of empty capsids (e.g., NMT 75%).
From: Typical mRNA (Drug Substance) Specifications
This instrument is used in the context of measuring the Quality Attribute mRNA Integrity / Size Heterogeneity with the following details:
- Purpose / Rationale: Confirms the presence and relative proportion of full-length mRNA and detects truncated or degraded species relevant to product quality, potency, and consistency.
- Typical Acceptance Criteria: • % Full-length (main peak): ≥80–95% (typical) (Range depends on construct length, sequence complexity, and process capability)• Truncated species: No single impurity >X% (product-specific limit; typically <5% per species)