Manufacturing & Quality
Manufacturing & Quality
BioPerfectus combines smart manufacturing, lifecycle quality management and global supply capabilities to support molecular diagnostic laboratories world wide.
Our portfolio of 700+ products, including PCR supplies, reagents and diagnostic instruments, supports diverse in vitro diagnostics needs.
Production Facility
Products
International Market Access Approvals
Countries & Regions
25000 m²+
Production Facility
700+
IVD Products
549+
International Market Access Approvals
100+
Countries & Regions
Inside the BioPerfectus Smart Factory
Explore authentic views of the BioPerfectus manufacturing facility—from automated production and equipment operation to quality control laboratories, intelligent warehousing and finished-product inspection.
A Global Diagnostics Partner Built on Manufacturing Excellence, Quality Assurance and Global Support
For laboratories sourcing PCR supplies and molecular diagnostics solutions, reliable performance begins with controlled manufacturing, consistent quality and a responsive global support network.
At our Taizhou headquarters and production center, our production facilities cover more than 25,000 m² and are supported by an automated, digitalized and interconnected manufacturing and supply chain system.
BioPerfectus’ capabilities include:
• Automated production lines
• Manufacturing Execution System (MES)
• Connected equipment with real-time data collection
• Enterprise Resource Planning (ERP)
• Warehouse Management System (WMS)
• Warehouse Control System (WCS)
• Automated Guided Vehicles (AGVs)
• Unmanned warehousing
Quality controls are integrated throughout IVD manufacturing, covering:
• Supplier qualification and incoming material control
• Raw material and intermediate product testing
• Production and in-process quality control
• Finished-product inspection and release
• Customer complaint handling, post-market surveillance, and continuous improvement
BioPerfectus uses batch production records and Unique Device Identification (UDI) to connect material, manufacturing, inspection and release data for end-to-end traceability.
In 2025, our products passed all 43 registration tests conducted by third-party testing institutions and all 15 market surveillance sampling inspections conducted by national and local authorities.
Through our integrated global operations and partner network, BioPerfectus delivers PCR products and in vitro diagnostics solutions to customers in more than 100 countries and regions.
Our global support includes:
• Technical and after-sales support
• Remote troubleshooting and application support
• Product training and technical guidance
• Local teams and warehousing in the United States and Brazil
• A worldwide partner network
Customer Success Stories
Trusted by laboratories and public health partners worldwide.
United States | Efficient Multiplex PCR Testing
Portugal | A Reliable Total PCR Workflow
During the COVID-19 pandemic, BioPerfectus supported Avelab with an integrated workflow spanning nucleic acid extraction, amplification and analysis. The partnership later expanded to PCR instruments and women’s health diagnostics.
Laos | Building Public Health Laboratory Capacity
BioPerfectus supplied the National Center for Laboratory and Epidemiology with nucleic acid extraction kits, automated extractors and timely technical support, strengthening laboratory readiness for COVID-19 and other infectious disease threats.
Indonesia | Flexible Solutions for Diverse Laboratories
National laboratories, private laboratories and hospitals adopted BioPerfectus extraction systems and Total PCR Solutions to manage different sample volumes and support infectious disease diagnosis and management.
Serbia | Improving Access to HPV Genotyping
BioPerfectus supported Aqualab Laboratory with PCR supplies for 21-genotype HPV detection and broader STI testing, helping expand access to timely and reliable women’s health diagnostics.
Ecuador | Supporting Public Health Response
BioPerfectus worked with laboratories of Ecuador’s Ministry of Health, providing nucleic acid extraction, real-time PCR systems and assays to support the detection of mpox, COVID-19, influenza and vector-borne diseases.