Frequently Asked Questions (FAQs)
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Have questions about sterile fill-finish manufacturing? You’re in the right place. Browse our frequently asked questions to learn more about Argonaut’s capabilities, aseptic manufacturing processes, quality standards, tech transfer, combination products, and what to expect when partnering with our team.
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Why does product yield matter?
Higher product yield helps maximize patient doses, reduce manufacturing costs, and conserve valuable drug substance.
Why should I choose an isolator-based filling line?
Isolators provide the highest level of sterility assurance and are the preferred aseptic processing technology of regulators worldwide, including the FDA and EU authorities.
Do you sterilize and fill into bulk glass vials?
No. We fill ready-to-use (RTU) vials.
Do you work with sponsors outside the United States?
Yes. We routinely work with biotechnology and pharmaceutical companies around the world.
How do you ensure product quality?
We use automated, isolator-based filling technology, robust in-process controls, environmental monitoring, and a validated quality system to ensure product quality.
Do you support process validation?
Yes. We support process validation activities required for commercial manufacturing.
Is PUPSIT available?
Yes. Pre-Use Post-Sterilization Integrity Testing (PUPSIT) is available.
Which regulations and quality standards does Argonaut comply with?
Our operations align with FDA 21 CFR 210/211/820, Annex 1, USP, EP, and JP requirements.
Do you perform release testing?
Yes. We perform release testing to verify product quality and compliance before distribution.
Do you perform container closure integrity testing?
Yes. We perform non-destructive CCIT using a Lighthouse CO₂ headspace analyzer.