Scott Goldstein, the Vice President of Strategic Partnerships at Argonaut Manufacturing Services, caught up with Perry Rearick at Outsourced Pharma to present a webinar covering Argonaut’s sterile fill-finish capabilities, recent facility expansions, and strategic positioning in the CMO (contract and manufacturing organization) space. A summary of the transcript is presented below:
Introduction to Argonaut’s sterile fill-finish capabilities
Based in Carlsbad, California and celebrating our tenth year in operation, we continue to grow as a nimble, innovative CMO specializing in sterile fill-finish manufacturing. We support clinical and commercial programs, with deep experience in biologics, oligonucleotides, and rare disease therapeutics. Our goal is to be more than a service provider—we aim to be a strategic partner who delivers speed, quality, and adaptability in a rapidly evolving pharmaceutical landscape.
Our sterile fill-finish capabilities have been designed for flexibility and efficiency.
Company Overview and Infrastructure
At Argonaut, we operate across four facilities in a five-mile radius, totaling 110,000 square feet. With a team of 120 dedicated professionals, we support both sterile and non-sterile manufacturing, including diagnostics and medical devices. We are FDA 21 CFR 210/211 compliant and ISO-certified for medical devices and combination products. Over the past year, we’ve been audited by multiple global agencies and are proud to maintain EU Annex 1 compliance supporting multiple QP audits each year. While our current clients focus on clinical programs, we’re manufacturing drug product for four Phase 3 projects and preparing for our first pre-approval inspections in anticipation of commercial manufacturing by next year
Technical Capabilities and Facility Expansion
Our sterile fill-finish capabilities have been designed for flexibility and efficiency. Line 1 is a Bausch+Ströbel VarioSys filling line inside a SKAN isolator, perfect for small, high-value batches—ideal for rare diseases and oligonucleotide-based therapies. This line handles volumes from 200ml up to 200L with batch sizes up to 20,000 2R vials in a shift with features like nitrogen overlay, 100% non-destructive weight check, near-zero line losses, and robotic vial handling. Line 2, our newest addition, is an Optima filling system integrated in an Optima isolator. It is a MultiUse Filling Line capable of filling vials, syringes, and cartridges with minimal changeover. With more than four times the capacity of Line 1, it can produce up to roughly 90,000 units per shift and includes 100% non-destructive weight checks—even for syringes and cartridges. This line will be ready for cGMP manufacturing in Q1 of 2026. Argonaut has already secured the first commercial contract for this new line.
Working with Us – Flexible, Fast, Collaborative
We pride ourselves on moving quickly when it matters most. Argonaut’s sterile fill-finish capabilities excels in small-batch fills with low line loss production for rare diseases. One client example involved producing an urgently needed ultra-rare disease drug product within two months, including tech transfer, where we achieved a 99% bulk accountability on the batch. Another client switched CMO’s mid-project, and Argonaut completed the batch within 35 days while achieving a 120% yield improvement over the previous manufacturer. Argonaut’s ability to adapt quickly, along with our focus on high value APIs and oligonucleotide manufacturing (e.g., ASOs, siRNAs), positions it as a strategic partner for cutting-edge gene therapies and personalized medicine.
Our goal is to be more than a service provider—we aim to be a strategic partner who delivers speed, quality, and adaptability in a rapidly evolving pharmaceutical landscape.
Conclusion
At Argonaut, we’ve built our foundation on responsiveness, technical expertise, and regulatory strength. Whether it’s supporting a fast-tracked rare disease program or preparing for a commercial launch, we bring experience, cutting-edge equipment, and commitment to every project. Our new Optima line reflects our forward-looking approach—scaling with our clients’ needs and expanding capacity for the future. Everything we do is about maximizing yield, minimizing risk, and moving products through development as smoothly as possible. With all our operations based in California, we’re proud to support the biopharma industry from right here in the U.S., and we look forward to growing alongside our partners.
View the webinar here:
Contact us and ask us more about our sterile fill-finish capabilities.
