About Solarbio¶
Beijing Solarbio Science & Technology Co., Ltd. (Solarbio) is a manufacturer and supplier of life science research products headquartered in Beijing, China. Established in 2004, the company has developed a product portfolio of over 10,000 SKUs serving academic, clinical, and industrial research laboratories worldwide across more than 60 countries. Solarbio operates under four internationally recognized quality management system certifications: ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and ISO 45001:2018.
Company History and Milestones¶
| Year | Milestone |
|---|---|
| 2004 | Company founded in Beijing, initial focus on biochemical reagents |
| 2008 | Expanded product line to include ELISA kits and molecular biology reagents |
| 2012 | Launched full range of enzyme activity assay kits (oxidative stress, metabolism) |
| 2015 | Achieved ISO 9001:2015 Quality Management System certification |
| 2016 | Expanded antibody portfolio; introduced HRP-conjugated secondary antibodies |
| 2017 | ISO 9001:2015 recertified; achieved ISO 13485:2016 for medical device QMS |
| 2018 | Established temperature-controlled warehousing and cold chain logistics |
| 2019 | Achieved ISO 14001:2015 Environmental Management certification |
| 2020 | Achieved ISO 45001:2018 Occupational Health and Safety certification |
| 2021 | Implemented 2010 Revised GMP-compliant production lines for IVD reagents; obtained NMPA GMP inspection certification |
| 2022 | Surpassed 10,000 active SKUs across all product divisions |
| 2023 | Obtained NMPA Class I Medical Device Filing Certificates for multiple buffer and staining reagent products |
| 2024 | Expanded Class II IVD reagent registration pipeline (ELISA kits, clinical chemistry assays); obtained Medical Device Production License |
| 2025 | Ongoing expansion of Class I/II medical device product portfolio and custom synthesis/OEM capabilities |
Quality Philosophy¶
Solarbio operates under a comprehensive quality management framework that governs every stage of product development and manufacturing:
- Raw Material Qualification: All raw materials undergo identity verification (NMR, FTIR, or HPLC retention time matching) before batch production. Supplier audits are conducted annually for critical raw materials.
- In-Process Quality Control: Manufacturing processes include in-process sampling at defined checkpoints. Key parameters (pH, conductivity, enzyme activity, purity by HPLC area%) are monitored in real time.
- Final Lot Release: Each manufactured lot is tested against established specification limits. Release criteria include identity, purity, potency (where applicable), appearance, and packaging integrity. A Certificate of Analysis (COA) is generated for each released lot.
- Stability Monitoring: Representative lots from each product category are placed on an accelerated and real-time stability program (ICH Q1A principles). Data from stability studies inform shelf life assignments printed on product labels.
- Non-Conformance and CAPA: Any out-of-specification result triggers a formal investigation under a Corrective and Preventive Action (CAPA) system. Root cause analysis is documented, and corrective actions are verified for effectiveness.
Core Business Divisions¶
| Division | Product Range | Annual SKU Count | Primary Markets |
|---|---|---|---|
| Molecular Biology | PCR/qPCR master mixes, DNA/RNA extraction kits, competent cells, cloning reagents | 2,000+ | Academic labs, biotech R&D, clinical diagnostics |
| Cell Biology | Culture media, apoptosis detection kits, proliferation assays, transfection reagents | 1,500+ | Cell biology research, drug screening |
| Immunology | Sandwich ELISA kits, competitive ELISA kits, primary and secondary antibodies, IHC reagents | 3,000+ | Clinical research, immunology, infectious disease |
| Biochemical Assays | Enzyme activity kits, oxidative stress markers, metabolism assays, protein quantification | 1,500+ | Pharmacology, toxicology, food science |
| Biochemical Reagents | Buffers and solutions, small molecules, analytical standards, staining dyes | 2,500+ | All laboratory types, analytical chemistry |
R&D Capabilities¶
Solarbio maintains a dedicated research and development group focused on:
- Assay Development: Design and validation of new biochemical assay formats, including colorimetric, fluorometric, and chemiluminescent detection methods. Each new assay undergoes linearity, precision, accuracy, and specificity validation.
- Antibody Production: Polyclonal and monoclonal antibody development using hybridoma technology and recombinant expression systems. Antibodies are validated by western blot, ELISA, IHC, and flow cytometry.
- Reagent Formulation: Optimization of buffer compositions, stabilizers, and preservatives to maximize reagent shelf life and performance across storage conditions.
- Custom Synthesis: Custom peptide synthesis, small molecule synthesis, and formulation services for OEM partners.
Manufacturing and Production Infrastructure¶
Solarbio operates production facilities equipped with:
| Capability | Equipment Types | Applications |
|---|---|---|
| Chemical Synthesis | Reactors (1 L–500 L), rotary evaporators, preparative HPLC | Small molecule reagents, buffers, dyes |
| Biotechnology Production | Fermenters, bioreactors, sterile filling lines | Enzymes, antibodies, competent cells |
| Quality Control Analysis | HPLC, UPLC, LC-MS, GC-MS, UV-Vis, FTIR, fluorescence plate readers | Identity, purity, potency, stability testing |
| Cold Chain Storage | −80°C freezers, −20°C freezers, 2–8°C cold rooms, temperature-monitored RT warehousing | All temperature-sensitive products |
| Packaging and Labeling | Automated filling, labeling, and barcoding lines with lot traceability | Final product packaging from 1.5 mL tubes to 500 mL bottles |
GMP Compliance and Medical Device Manufacturing¶
Solarbio operates GMP-compliant production lines for in vitro diagnostic (IVD) reagents in alignment with China's 2010 Revised GMP and international cGMP standards (ICH Q7, WHO TRS). The GMP production facility is subject to routine NMPA on-site inspection and certification.
Medical Device Registration¶
| Classification | Scope | Certificate Type | Validity |
|---|---|---|---|
| Class I (备案) | General laboratory reagents, buffer solutions, staining reagents not intended for diagnostic use | NMPA Filing Certificate | Ongoing |
| Class II (注册) | Clinical IVD reagents: ELISA kits (cytokine quantification), clinical chemistry assays (ALT, AST, creatinine, BUN), PCR-based detection reagents | Medical Device Registration Certificate (医疗器械注册证) | 5 years (renewable) |
| Production License (生产许可证) | Manufacturing site for Class II IVD reagents | Medical Device Production License (医疗器械生产许可证) | 5 years (renewable) |
GMP-Certified Production Infrastructure¶
The GMP production area includes:
- Cleanroom: ISO 14644 Grade D (Class 100,000) classified filling and compounding areas with HEPA filtration, pressure differential monitoring, and environmental monitoring (particulate count, microbial settling plates)
- Water System: Pharmaceutical-grade purified water and WFI (water for injection) distribution systems with validated loop, conductivity monitoring, and microbial testing
- HVAC: Validated heating, ventilation, and air conditioning system with temperature/humidity control and HEPA-filtered supply air
- Process Validation: All critical manufacturing processes validated per ICH Q8/Q9/Q10 lifecycle approach; media fill validation for aseptic operations; cleaning validation with swab and rinse sampling
- QC Laboratory: Dedicated GMP QC lab with HPLC, GC-MS, UV-Vis spectrophotometry, and microplate readers; method validation per USP/EP/JP compendial methods; stability testing per ICH Q1A
For detailed GMP and regulatory documentation, see GMP Compliance & Medical Device Registration.
Global Distribution and Logistics¶
| Shipping Method | Temperature Range | Typical Products | Packaging | Transit Time (Intl) |
|---|---|---|---|---|
| Ambient | 15–30°C | Buffers, DNA extraction kits, solutions | Standard corrugated box with cushioning | 5–12 business days |
| Cold pack | 2–8°C | ELISA kits, antibodies, assay kits | Insulated box with gel packs + temperature logger | 5–10 business days |
| Dry ice | −20°C to −80°C | PCR master mixes, competent cells, enzymes, small molecules | EPS box with dry ice + temperature logger | 3–7 business days |
International shipments are handled through authorized courier partners with customs documentation support. Temperature indicators are included in all cold chain shipments. Customers receive tracking information upon dispatch.
Customer and Technical Support¶
| Service | Availability | Contact Channel |
|---|---|---|
| Product selection guidance | Business hours | Via solarbio.store |
| Protocol technical support | Business hours | Via solarbio.store |
| COA requests | Upon request (provide lot number) | Via solarbio.store |
| Custom manufacturing inquiries | Project-based | Via solarbio.store |
| Distributor registration | Ongoing | Via solarbio.store |
For commercial procurement, custom manufacturing requests, or distributor inquiries: visit solarbio.store