We got you covered. Our exceptional capabilities and infrastructure extend into contract manufacturing services for your IVD and RUO products with all the experience, quality, and efficiency given to Monobind's (150+ IVD) products. Stemming from our regulatory experience (45+ years) and compliance, including ISO 13485 Certification, CA Food and Drug Manufacturing License, cGMP, FDA 21 CFR 820 and Part 210, and as a FDA Registered Establishment, we accelerate our clients time to market. With Monobind's QMS, we offer complete QC/QA services, including needed analytics (product performance studies) and regulatory support. And when the rubber meets the road, Monobind has state-of-the-art systems and automation for:
- Scale-up & flexible manufacturing schedules with product lifecycle support, including supply chain management and market supply
- Three fully automated dispensing lines filling 0.5ml to 22ml volumes per vial - with labeling, ink-jetting and capping. Monobind offers high volume manufacturing, with capacity to dispense 4M+ bottles per year on a single work-shift
- Lyophilization capability for 0.5ml to 3ml fill volumes in large capacity dryers with batch sizes up to 7K bottles
- Plate-coating on two automated lines, with additional semi-automated line for smaller batches or specialty coats, processing 12K+ microplates per week with a single work-shift, more capacity may be unlocked with extended hours or second shift
- Product configurations, formulations, assay development, performance studies, kitting and drop shipping
Contact us to discuss your unique needs! Let's work together to bring your product to market and support its growth.