Attention to detail.
Rely on our team of experts and established processes.

Being assured that the products you take to market are free of containment and are produced to specification is of utmost concern for any pharmaceutical company. When you partner with Bushu Pharma, you can rest assured that you will receive the highest level of analytical and quality control.

Our company works closely with each and every customer to set specifications, develop, validate, and operate strong analytical procedures, sample, test, and control all raw materials, intermediates and final products, and ensure analytical support for all manufacturing and distribution operations.

Backed by this commitment to quality, we are able to offer a robust technology transfer package, with a strong focus on analysis infused throughout our operations. Of course process development and technology transfer is much more than a simple chemical equation - you also have to ensure you build consensus on how to ensure an accurate transfer of the technology.

• Analysis & Testing

  Analysis and Technical Transfer based on GMP certifications in 56 countries around the world.

  In addition to the transfer of analytical technologies, testing of raw materials received, quality analysis of the manufacturing process, and testing prior to shipment accompanying contract manufacturing, we also accept contracts for services such as testing prior to shipment and the respective analyses alone.

  Driven by our GMP experience and qualifications - built on extensive experience with inspections in Japan and overseas - we are able to conduct tests on a wide range of pharmaceutical products from low-molecular weight drugs to high-molecular weight drugs. In particular, we have the technologies and facilities to handle the testing of biopharmaceuticals such as antibody drugs, and we are able to provide testing using cultured cells (cell-based assay) that require sophisticated techniques.

  We also have a laboratory for high potency substances and technologies to analyze foreign matter and are able to meet the varied analytical needs of our customers with regards to pharmaceutical products.

  Testing Details

  Bushu Pharma has extensive on-site training experience - not only in Japan but also at overseas laboratories - and has a wide range of skills in the analysis of bio-pharmaceuticals.

  In addition, we have a strong track record of accepting technology transfers from overseas laboratories, and are able to offer a flexible response.

  • Key testing areas

    •  · Biochemical testing
      (quantitative, potency such as enzyme activity)
    •  · Biological testing (Cell-based assay)
    •  · Immunological testing
      (ELISA,Western Blotting)
    •  · Electrophoresis
      (SDS-PAGE, Isoelectric Focusing, Capillary Electrophoresis)
    •  · Chromatography
      (Size-Exclusion Chromatography, Ion Exchange Chromatography)

  Regardless of dosage form, Bushu Pharma is able to conduct testing in compliance with GMP for various types of pharmaceutical products, and we have a track record of acquiring GMP certification from the authorities of the respective countries including FDA, enabling us to offer testing in compliance with the three authorities of JP/EP/USP. With regards to stability testing, we have multiple large walk-in chambers and reach-in chambers, and we are able to offer stability testing with the storage requirements in line with customer needs.

  •  · Quality testing
    (physicochemical test, microbial test, packaging material test)
  •  · Analytical validationAnalytical validation
  •  · Elemental impurities testing(in compliance with ICH QCD)
  •  · Stability test
    (25°C/60%RH, 30°C/65% (75%)RH, 40°C/75%, 5°C, -20°C, etc.)
  •  · Analysis of foreign matter

  Transfer of analytical technologies

  Bushu Pharma has extensive on-site training experience - not only in Japan but also at overseas laboratories - and has a wide range of skills in the analysis of bio-pharmaceuticals.
  In addition, we have a strong track record of accepting technology transfers from overseas laboratories, and are able to offer a flexible response.

  Analysis for quick response for customer complaints

  •  · Foreign matter analysis investigation
  •  · X-ray Microscope
  •  · FT-IR

  Main Equipment

  • Main Equipment

    HPLC/UPLC (Detectors: UV-Vis, PDA, RI, ESLD, FLR, CAD), GC (Detectors: FID, TCD), Dissolution Apparatus (Paddle, Basket, Flow-Through Cell), UV-Vis Spectrophotometers, Fluorescence Spectrophotometers, Atomic Absorption Spectrophotometers, XRD, FT-IR, NIR, Microwave Digestion Systems, ICP-OES, ICP-MS, Zetasizers, Handheld Raman Analysers

  • Highly Potent Active Pharmaceutical Lab

    Chemical Fume Hoods, Chemical Hazard Isolators

  • Foreign Matter Analytical Lab

    Digital Microscopes, X-ray Analytical Microscopes, Micro Raman Spectrometers, Micro FT-IR, X-ray CT

  • Microbiology and Biology Lab

    Aseptic Isolators, Biosafety Cabinets, Steam BIER, RiboPrinter System, VITEK-II Compact, Toxinometers, Microplate Readers

  • PDF

    Biopharmaceutical Testing and Equipment

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