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Analytical and Quality Control Services

Argonaut provides analytical and quality control services for biopharmaceutical, diagnostics, and life science organizations. 

Get the expertise and capabilities you need. Our comprehensive portfolio can help you at all growth phases- from development through scale-up, and pre-clinical through commercial. Our team is experienced and FDA- inspected. 

Analytical and Quality Control Services

Foundational and custom services are available:

Our foundational services include in-process and release testing, stability studies, raw material qualification, and retain management and storage. We can fully customize testing processes to meet your needs.  

Release Testing

  • Identity (e.g. spectroscopy, chromatography, immunoassay)
  • Potency/performance
  • Purity/impurities
  • Appearance and pH
  • Bioburden and microbiological
  • Labeling and packaging integrity
  • Regulatory and end-user requirements
Quality Control Services - Argonaut Manufacturing Services

Stability Studies

  • Long-term and accelerated conditions available
  • Freeze-thaw studies
  • ICH compliant storage conditions
  • ICH Q1A and EP-25A standards
  • Non-destructive container-closure testing (CCIT)
  • Microbiological testing

Raw Material Qualifications

  • Identity testing
  • Purity and impurities
  • Physical and chemical properties
  • Biological and/or functional testing
  • Bioburden/sterility/endotoxin
  • Full CofA or full compendial verification
Quality Control Services - Argonaut Manufacturing Services

Retain Storage and Inspection

  • Raw material retain management
  • In-process and final product sample storage
  • Environmental monitoring
  • Continuous batch-based sampling interval
  • Retains stored for expiration date/shelf-life, and audit testing

Custom Analytical and Quality Control Services

We can fully customize analytical testing processes and quality controls to meet your demands. With a fully equipped lab and experienced staff, we ensure your products meet the highest standards of accuracy, reliability, and regulatory compliance. 

  • Method verification and validation
  • Comprehensive reports
  • Regulatory submission assistance
Learn more about our available services...
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Compliance and Security

Staying current on both FDA and ICH guidelines in changing regulatory environments is challenging. Our team prioritizes the quality and security of your product. 

  • ISO 13485:2016
  • cGMP
  • QSR 21 CFR 820, 21 CFR 210, 21 CFR 211
  • ICH Q1
  • FDA registered and inspected
  • CA FDB inspected
  • Validated environments
  • 24/7 monitoring with validated building management system

Why Choose Argonaut

Leave the quality control testing to us. Unlike other contract manufacturers, we only perform contract services, so your satisfaction in our analytical and QC services are paramount. 

  • State of the art equipment
  • In-house microbiology lab
  • Tailored services
  • Highly experienced staff
  • Real-time quality monitoring
Quality Control Services - Argonaut Manufacturing Services
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Analytical testing services provided by Argonaut

Appearance USP <790>Bioburden USP <61>
Color and Clarity Ph. Eur 2.2.2 and 2.2.1Endotoxin USP <85>
pH USP <791>HPLC (RP- HPLC, IEX- HPLC, SEC-HPLC)
Conductivity USP <1644>CCIT via Carbon Dioxide Headspace Analysis – Lighthouse Instruments
Osmolality USP <785> FPDConcentration by UV/Vis & Fluorescence
Refractive Index USP <831>Concentration of Nucleic Acids
Container Content/Extractable Volume USP <697>FTIR
Viscosity USP <912>ELISA
Fats and Fixed Oil Analysis USP <401>RT- qPCR
DensityDNase and RNase Detection
Nitrates analysis for Purified WaterNicolet Summit FTIR - ThermoFisher
UHPLC- Agilent 1290 Infinity IIRX-5000i Digital Refractometer - Atago
SpectraMax 384 Plus Spectrophotometer- Molecular Devices (cuvette and 96 well plate reader)D4 Density Meter – Mettler Toledo
Gemini XPS Microplate Spectrofluorometer- Molecular Devices (96 well plate)CTech SoloVPE System
Biotek ELx808 Plate Reader – Charles RiverTOC/Conductivity Analyzer- Sievers M9
Milliflex OasisLight Box, USP and Ph. Eur compliant –  Phoenix Imaging
NanoDrop OneC - ThermoFisherStability Storage 80°C, 20°C, 5°C, 25°C and 40°C  (with %RH for accelerated conditions)
Seven Compact pH Meter - Mettler ToledoStability Study management ICH Q1A R2 incl. Freeze Thaw studies
Seven Compact Conductivity Meter - Mettler Toledo
Fiske Micro-Osmometer Model 210 – Advanced Instruments

Argonaut Non-Aseptic Fill Finish FAQs

A: We provide a range of services, including raw material testing, in-process testing, final product release testing, and stability studies
A: We can design and execute stability testing programs in accordance with  ICH guidelines.
A: Argonaut offers controlled storage solutions and retain samples storage according to regulatory requirements or client-specific agreements.
A: Yes, we provide method transfer and validation services tailored to your product’s specific requirements.
A: Yes, we offer testing services for products at all stages, from clinical development through commercial production.
A: No, we have facilities and protocols to handle materials up to and including SafeBridge category 3 (OEL < 1µg/m3).
A: Yes, our comprehensive reports include all required data, analysis, and documentation to support regulatory filings and audits.
A: We provide full audit support, including document preparation, participation in inspections, and responding to regulatory inquiries.
A: Pricing is tailored to your specific QC requirements. During the project quoting process, we collaborate with you to assess your needs and incorporate the QC costs into the total project estimate. We can provide you with a price list for the transfer and execution of the various analytical methods we perform.
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Main Office
2841 Loker Ave E
Carlsbad, CA 92010

Contract Manufacturing Done Right.

Call us at +1 888-834-8892