The BPA Linearange Finder® II is an Automatic Concentration Analyzer independently developed by the BPA team and designed based on tangent spectroscopy. Whether your focus lies in monoclonal antibodies (mAbs), antibody‑drug conjugates (ADCs), immunoglobulins (Igs), antisense oligonucleotides (ASOs), plasmid DNA (pDNA) purity, or messenger ribonucleic acid (mRNA), the BPA LFII Automatic Concentration Analyzer supports your concentration‑analysis workflows with high stability, reliability, sensitivity and durability.

The BPA LFII Automatic Concentration Analyzer features fully Made-in-China core components. Its light sources, control systems and analytical software are all developed in-house. Breaking reliance on imported products, it provides stable and accurate concentration measurement solutions for users in many sectors including biopharmaceuticals.

As subcutaneous administration gains wider adoption in biopharmaceutical formulation development, protein concentrations in monoclonal antibody formulations continue to rise. Approximately one-third of FDA-approved mAb products are high-concentration formulations (> 100 mg/mL), around three-quarters of which were approved after 2015. High-concentration mAb formulations pose greater challenges across manufacturing processes (e.g., ultrafiltration/concentration of drug substance, mixing, filtration and filling), antibody quality attributes (protein aggregation and viscosity), and analytical methods.

Building on the Linearange Finder® I (5 μm pathlength resolution), the BPA team has iteratively developed the Linearange Finder® II (2 μm pathlength resolution), which significantly extends the upper detection limit for concentration measurement of high-concentration samples.

• Samples with concentrations as high as 350 mg/mL can be analyzed directly without dilution, eliminating errors introduced by dilution operations.
• Accurate concentration results can be obtained in approximately one minute, greatly reducing sample preparation time.
• Both the light source and pathlength control module are independently developed by BPA. Covering hardware, software and control systems, the instrument features full in-house development and integrated control. Compared with assembled hybrid instruments on the market, the BPA automatic concentration analyzer delivers superior compliance performance and unified, consistent after-sales support.
  
  

• The built-in security software covers user/user group management, permission control, audit trails and electronic signatures, fully complying with GMP and FDA 21 CFR Part 11 regulatory requirements.
• Adopting a database-based architecture, the system enables safer data storage and more convenient data management.
• The software supports both Chinese and English bilingual interfaces for intuitive and easy operation.

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