Contract Manufacturing

Scale Up with Confidence

From commercial product launch to full scale production, Viscus Biologics is proud to serve as your manufacturing partner.

We combine our deep manufacturing expertise with:

flexibility,
responsiveness, and
an easy to work with team dedicated to your success.

Your Choice, Our Commitment

When you choose our team for your product manufacturing, we commit to continuously look for cost reductions, product performance improvements, time- and cost-efficient scale up, high-quality suppliers, and operational efficiencies through work cell optimization.

Whether you need 1 thousand or 1 million units per year, our facilities are designed for small- to production-scale manufacturing. Leveraging our D4 process (Define, Discover, Develop, Deliver), our contract manufacturing projects focus on the Develop and Deliver phases. If your product transfer includes design and/or process improvements, our team will deliver cost reductions, product performance enhancements, and improved manufacturability.

We have experience working with teams looking to:

Establish an alternate or additional contract manufacturing facility
Outsource manufacturing of their product’s commercial launch
Transition from low-volume manufacturing to higher volumes and improved operational efficiencies

We support 510k, de novo, and PMA submissions and provide all required documentation and information including Device Master Records (DMR) and Design History Files (DHF), and we support all relevant manufacturing activities from raw materials sourcing to packaging, sterilization, and batch release testing.

Contact us to discuss your manufacturing plan and requirements.

Let’s Talk Scaleup

Our Product Realization Capabilities

Component Sourcing

We source a wide range of research-grade and GMP xenograft tissues used for extracellular matrix scaffolds, natural and synthetic polymers, and specialty chemicals required for formulation, processing, and device development.

Decellularization

Our proprietary decellularization of xenograft tissues removes cellular components while preserving the extracellular matrix structure and bioactive cues essential for tissue remodeling and regeneration.

Lyophilization

Lyophilization (freeze drying) of extracellular matrix-based tissues and other biomaterials enables the production of stable sheets, powders, granules, and other dry formats suitable for manufacturing and long-term storage.

Particle Size Reduction

Our specialized milling equipment reduces extracellular matrix-based tissues and other biomaterials into controlled, consistent particle sizes suitable for downstream formulation and blending.

Additive Manufacturing & Bioprinting

We operate CELLINK Bio X-series bioprinters, Ultimaker fused-filament printers, and Formlabs stereolithography (SLA) platforms to support advanced prototyping, custom biomaterial fabrication, and product development.

Testing & Characterization

We maintain comprehensive testing and characterization programs that include mechanical testing, immunoassays, endotoxin testing, biocompatibility testing, viral clearance, shelf-life testing and more.

Packaging & Labeling

Our cleanroom pouch sealing, filling and device packaging capabilities support sterile handling and final presentation of medical devices, gels, and powders in a controlled environment throughout the packaging workflow.

Sterilization

We utilize autoclave sterilization for in-process equipment and fixtures and employ validated external partners for ethylene oxide (EtO), electron beam (E-beam), and gamma irradiation to ensure product safety.

Cleanroom Manufacturing

Our FDA-registered facility supports scale up and cost optimization and enable the production of devices in a controlled ISO Class 7 cleanroom setting with strict environmental monitoring, climate control, and segregated functional zones.

Regulatory

We work with our customers’ regulatory teams, offer full regulatory support, or a combination of both to prepare 510(k), De Novo, and Premarket Approval (PMA) submissions and generate submission-ready data packages.

Quality

We produce innovative and reliable medical devices and components using our Greenlight Guru electronic quality management system and are committed to establishing a quality culture and providing quality products.

Logistics

We offer robust logistics services leveraging our enterprise ERP system to manage pick-pack-ship activities and can provide product storage, distribution support, supplier coordination, and finished-goods management.