With concept testing finished, it is time to get your new product configured. From incremental to break-through products, Argonaut and its ecosystem partners have extensive experience in this key stage, having launched hundreds of products in the industry. Our team can help your team:
- Device design, development, and testing
- Cartridge design, development and testing
- Design documentation
From developing to optimizing processes, Argonaut improves your biotech manufacturing quality and reliability:
- Development of cGMP documentation – raw material specs, SOPs, master batch records, work instructions, and more.
- Process equipment procurement, installation, and qualification
- Demonstration runs at current scale
- Develop scale up/automation strategies
- Engineering runs at production scale
- Development of labels, packaging components, and kit configuration
Bridging skills, technologies and manufacturing methods between facilities can be difficult to execute. Leveraging the Argonaut team with yours makes transitions easier than ever:
- Creation of process documents, converting existing docs to AMS format – raw material specifications, SOPs, master batch records, work instructions, label/carton proofs, pack out instructions, and more.
- Transfer of existing manufacturing process to AMS, including on site training, process equipment installation, and qualification
- Engineering runs at scale
- Validation runs at scale
Balancing capacity with demand forecasts requires planning and operational flexibility. High mix, low volume products can be particularly problematic. Argonaut handles your cGMP manufacturing requirements- from the routine to the complex:
- Bulk formulation and filtration
- Filling into tubes, vials, bottles, syringes, cartridges
- Device/cartridge assembly
- Labeling, packaging, and kitting
- Process performance qualification
Shifting gears from liquid to lyophilization formats provides both excellent operational and end-user benefits. Improve product stability, remove cold chain, reduce shipping costs, and lower your carbon footprint by going ambient.
- LyoDose Beads- perfect for reactions requiring specific unit dosage (e.g. PCR)
- Vials and Powder
- Custom formulations- from latex beads to paramagnetics
- Excipient screening
- Feasibility and stability studies
- Scale-up cGMP manufacturing
- Labeling, packaging and kitting
Quality is the key to biotech manufacturing and Argonaut can assist your efforts, from preclinical through commercialization. Our dedicated team, equipment, and expertise supplements yours.
- Analytical method transfer, qualification, and validation
- Raw material qualification
- In-process testing
- Lot release testing
- Stability studies
Preventing defects from entering your product build gives you confidence the standards you establish are being met. Argonaut can help qualify systems and suppliers, inspect reagents or materials, and train staff on risk mitigation.
- Supplier qualification – questionnaire, on site audit and report
- Supplier investigations
Shipping & Storage
From shipping validation studies through pick, pack, and ship, Argonaut can enhance your fulfillment strategies. Want to keep your on-site facilities maximized towards research and development? Free up high-value space using dedicated Argonaut warehousing for storing raw materials and finished goods.
- Development of pack out instructions
- Shipping studies
- Pick-Pack-Ship fulfillment program
- Product storage at RT, 4C, -20C, -80C