Clinical Chemistry Reagent Formulation Solutions

Professional Formulation Development for Clinical Chemistry Diagnostics

We specialize in the research, development, and optimization of clinical chemistry reagent formulations, supported by years of hands-on experience in assay design, stability engineering, and production-scale validation.

Our mission is to help diagnostic manufacturers and laboratories launch high-quality, stable, and analyzer-compatible reagents efficiently, while reducing development risk and time to market.

We provide customized formulation solutions, tailored to your assay requirements, production conditions, and target analyzer platforms.

Supported Assays & Representative Methodologies

We cover a broad range of routine clinical chemistry parameters using internationally recognized and widely adopted methodologies, including IFCC, DGKC, and other mainstream reference methods.

Enzyme & Metabolite Assays

• ALT (Alanine Aminotransferase)
  Two-reagent system (4:1), Tris buffer, NADH kinetic method

• AST (Aspartate Aminotransferase)
  Two-reagent system, IFCC-recommended method

• Urea (UREA)
  Two-reagent system, Urease–GLDH kinetic method

• Creatinine (CRE)
  Enzymatic method (Creatininase–Creatinase–Sarcosine Oxidase cascade)

• Uric Acid (UA)
  Two-reagent system, Uricase–Peroxidase Trinder endpoint method

• Glucose (GLU)
  Hexokinase method or Glucose Oxidase method

Lipid Profile Assays

• Total Cholesterol (TCHO)
  Single reagent, CHO–POD enzymatic method

• Triglycerides (TG)
  Single reagent, GPO–POD enzymatic method

• HDL-Cholesterol (HDL-C)
  Direct homogeneous enzymatic method

• LDL-Cholesterol (LDL-C)
  Direct homogeneous enzymatic method or calculated method

Proteins, Enzymes & Electrolytes

• Total Protein (TP) – Biuret method

• Albumin (ALB) – Bromocresol Green (BCG) method

• Alkaline Phosphatase (ALP) – PNPP substrate, AMP buffer

• GGT, CK, CK-MB, LDH, HBDH, Amylase, Lipase

• Total / Direct Bilirubin (TBIL / DBIL)

• Calcium, Phosphorus, Magnesium, Iron, Zinc, Copper

• Additional parameters available upon request

The above list represents typical examples. Our formulation library covers a significantly wider parameter range and continues to expand.

What We Provide

Formulation Package Only (No Physical Reagents)

We supply complete formulation documentation, including:

• Detailed formulation recipes

• Component lists and specifications

• Step-by-step preparation SOPs

• pH adjustment and buffer control guidelines

• Quality control targets

• Stability and storage considerations

All raw materials and reagent manufacturing are to be sourced and produced locally by the client, strictly following the provided SOPs.

Due to international transport regulations, hazardous chemicals (e.g. strong acids, strong alkalis, sodium compounds) cannot be shipped internationally and must be sourced locally.

Online Technical Guidance & Analyzer Adaptation

After purchase, we provide remote technical support, covering:

• Trial production guidance

• Troubleshooting and performance optimization

• Method fine-tuning for local raw materials

• Adaptation to open systems and branded platforms
  (e.g. Hitachi, Beckman, Roche, Mindray, etc.)

This ensures your formulation performs reliably under real production and analyzer conditions.

Our Core Strengths

• Deep expertise in mainstream international methodologies (IFCC, DGKC, etc.)

• Proven formulation strategies for stability, anti-interference, and wide linearity

• Excellent batch-to-batch consistency design

• Seamless support from lab-scale trials to mass production

• Strict confidentiality — formulations and SOPs are shared only after NDA execution

Our Recommendation for First-Time Manufacturers

If you are new to chemistry reagent production, we strongly recommend starting with concentrated reagent kits before moving directly into full formulation development.

Why?

Both concentrated reagent production and full formulation manufacturing involve critical steps such as dilution, filtration, and process control.
By working with concentrated kits first, you can:

• Gain practical experience in dilution ratios and filtration procedures

• Understand enzyme handling and buffer behavior

• Reduce risk when transitioning to full formulation-based production

This approach significantly smooths the learning curve and improves success when you later implement complete formulation solutions.

Most Frequently Purchased Concentrated Reagents (Examples)

(Partial list – available in 5× / 10× / 20× concentrations)

• ALB – BCG method

• TP – Biuret method

• ALT / AST – Substrate methods

• ALP – PNPP substrate, AMP buffer

• GGT – GCANA substrate

• TBIL / DBIL – Vanadate oxidation or Diazonium methods

• Urea – Urease–GLDH method

• UA – Uricase method

• TG – GPO-PAP method

• CHO – CHOD-PAP method

• GLU – GOD or Hexokinase method

• CK / CK-MB / LDH / HBDH

• Electrolytes & trace elements (Ca, P, Mg, Fe, Zn, Cu, etc.)

Detailed specifications, ratios, formats, and MOQ are available upon request.

Let’s Discuss Your Project

The above represents only part of our technical capabilities.
We maintain a comprehensive formulation library and continuously develop new assays based on market and client demand.

If you have specific parameters, target analyzers, or development goals, feel free to contact us.
We are happy to explore cooperation opportunities under confidentiality and provide tailored formulation solutions with professional online guidance.