Turnkey Biotechnology Manufacturing Services
MFG One delivers secure, compliant, cost-effective turnkey biotechnology manufacturing. Our USA-based facility mitigates outsourcing risks and ensures quality, IP protection, and on-time delivery. Focus on your core innovation; we’ll handle the rest.
We manage every step from design to box build with our turnkey contract manufacturing.
20+ years of experience in biotechnology manufacturing and large-scale production.
Providing rapid turnaround and adherence to the highest quality standards.
Applications We Support
MFG One provides custom manufacturing services for various critical biotechnology applications. Over the years, we’ve partnered with established medical device companies to deliver high-quality, reliable products that meet the industry’s stringent demands.
We specialize in manufacturing sophisticated medical equipment, ensuring precision and reliability for optimal performance. Our capabilities include electronic product design and development, subassemblies, testing, packaging, and reverse engineering.
- Diagnostic devices (e.g., PCR machines, blood analyzers)
- Therapeutic devices (e.g., drug delivery systems, infusion pumps)
- Laboratory instruments (e.g., centrifuges, spectrometers)
Our expertise extends to the manufacturing of bioprocessing systems. We focus on maintaining quality and cost-effectiveness throughout the production process.
- Single-use systems for upstream and downstream processing
- Bioreactors and filtration components
MFG One delivers robust and reliable pharmaceutical manufacturing equipment solutions, including automation and quality control instrumentation.
- Automation systems for drug production
- Quality control instruments
Our capabilities support the development of rapid test kits and lab automation equipment, including components that require precision and consistency. We also offer box-build printed circuit board assembly services for your electronic components.
- Components for rapid test kits
- Lab automation equipment
Turnkey Manufacturing Solutions
Simplify your production process with MFG One’s turnkey custom biotechnology manufacturing solutions. We streamline your product’s journey from design to delivery, eliminating the bottlenecks in managing your own production and letting you focus on your business’ greater priorities.
Core Box Build Manufacturing Services
MFG One offers medical device new product development and existing product development services, delivering fully integrated and tested products ready for your end-users. We specialize in streamlining the complexities of box build assembly by providing high-quality and efficient production for your most demanding biotechnology manufacturing projects.
Core Capabilities
Turn-Key Complete Box-Build Assembly
End-to-end integration and assembly designed for biotechnology solutions. Examples:
- Diagnostic tools, including PCR machines and blood analyzers
- Lab instruments such as centrifuges and spectrometers
- Therapeutic delivery systems, including infusion pumps and drug delivery devices
Printed Circuit Board Assembly (PCBA)
Precision assembly of electronic components using advanced electronics manufacturing services. Examples:
- PCBA for diagnostic equipment and laboratory automation tools
- Electronics for quality control and data logging systems in biotech
Plastic Injection Molding
Our expert plastic injection molding services offer durable and customized components. Examples:
- Enclosures for diagnostic devices
- Connectors and single-use components for bioprocessing systems
- Fluidic paths and custom plastic parts for lab tools
Mold Tooling
Cost-effective molds specifically for biotech applications, ensuring accuracy and consistency for high-volume manufacturing of critical components.
Metal Fabrication
Robust metal components for high-performance biotech equipment. Examples:
- Structural parts for lab instruments
- Frames and casings for medical and bioprocessing systems
Addressing Your Outsourcing Concerns
With decades of experience in turnkey manufacturing for established biotechnology companies, we understand the challenges of outsourcing and offer proactive solutions to provide a smooth and successful partnership.
- Lead Time: Our facility based in Chantilly, Virginia, USA, delivers predictable lead times.
- Quality: MFG One is ISO 13485 certified, FDA compliant, with a 100% clean audit record (7 consecutive years - no FDA or ISO findings).
- Transparency: Open-book costing and dedicated program managers for complete visibility.
- IP Protection: We have strict protocols to safeguard your product’s intellectual property.
- Compliance: We have a team of experts experienced in navigating FDA registration and other key certifications.
Why Choose Us for Biotechnology Manufacturing?
As an experienced contract medical device manufacturer, MFG One provides the expertise, quality, and transparency you need to bring your biotechnology innovations to market confidently.
We handle every stage of the process, from initial design and engineering to box-build assembly, fulfillment, and aftermarket support.
Delivering exceptional results through our extensive medical device design manufacturing experience.
Our strategically located facility near Washington Dulles International Airport enables efficient logistics and rapid turnaround times.
We offer the flexibility to handle medium-batch to large-volume production runs, adapting to your evolving needs.
We’re committed to building long-term partnerships, providing the ongoing support and expertise you need to achieve your strategic manufacturing goals.
Partner With Us Today
Contact us to discuss your biotechnology manufacturing needs anywhere in the world. We support companies in the US, Canada, UK, Mexico, and beyond. Explore how our turnkey services can help your next initiative.