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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Frequently Asked Questions (FAQs)
Frequently Asked Questions (FAQs)
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Frequently Asked Questions (FAQs)
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How do you determine pricing for QC services?
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.
What kind of support do you offer during audits or regulatory inspections?
We provide full audit support, including document preparation, participation in inspections, and responding to regulatory inquiries.
Do you provide detailed QC testing reports?
Yes, our comprehensive reports include all required data, analysis, and documentation to support regulatory filings and audits.
Can you handle testing for high-potency or hazardous materials?
No, we have facilities and protocols to handle materials up to and including SafeBridge category 3 (OEL < 1µg/m3).
Can you support testing for both clinical and commercial products?
Yes, we offer testing services for products at all stages, from clinical development through commercial production.
Can you transfer and validate custom assays?
Yes, we provide method transfer and validation services tailored to your product’s specific requirements.
How do you handle sample storage and retention?
Argonaut offers controlled storage solutions and retain samples storage according to regulatory requirements or client-specific agreements.
Do you offer stability testing programs?
We can design and execute stability testing programs in accordance with ICH guidelines.
What types of QC testing services does Argonaut offer?
We provide a range of services, including raw material testing, in-process testing, final product release testing, and stability studies
What are your lead times for terminal sterilization services, from initial engagement to product delivery?
This is largely dependent on the complexity of the project, readiness for manufacturing, and availability of materials. Pilot projects or engineering builds can often be executed in less than three weeks.