NIPPON SHOKUBAI CO., LTD.

Process Development Analytical Development

Our Services

Process Development

We can manufacture our products following the recipe given by our customers or by developing a manufacturing process from scratch.

As a CDMO, we manufacture oligonucleotide and peptide APIs of high quality using advanced technologies. Please contact us for services ranging from small-scale synthesis for drug efficacy and toxicity studies in the drug discovery stage to contract research on process development and test development for pilot manufacturing, and GMP-compliant API manufacturing for clinical trials.

In process development, we propose an evaluation proposal based on consultations with our customers and create a robust manufacturing method.
This method can be transferred to us by the customer, built by us from scratch, or proposed by us following technology transfer from the customer.

In addition to scale-up and scale-down studies, we extract critical factors that affect the amount of impurities and confirm the control range using statistical analysis software. We support quality risk management with Quality of Design in mind.

Facilities

  • M-4, M-8

  • OligoPilot Plus 100

  • Liberty Blue HT

  • Examination of reaction conditions (solid-phase synthesis conditions, cleavage and deprotection conditions, etc.)
  • Fractionation and purification (ion exchange, reversed-phase chromatography, etc.)
  • Ultrafiltration
  • Lyophilization
  • Counter ion exchange

Analytical Development

Providing seamless analytical development services suitable for applications

We develop analytical methods for various testing items required for the quality control of oligonucleotide & peptide drugs, such as purity, quantitative determination methods, moisture, endotoxin, molecular weight confirmation, and sequence analysis, in a manner suitable for your development stage from exploration research to commercial stage.

We offer services for analytical method validation, specifications of raw materials and test methods, quality testing of APIs and intermediates, impurity evaluation, stability testing, etc., in a manner suitable for your development stage from explanatory research to clinical trials. Our expert team will develop and provide analytical methods for oligonucleotides and peptides using our comprehensive facilities.

Facilities

  • UHPLC-MS

  • 2D LC

  • High-resolution MS

  • Analytical method validation (RP, IEX, SEC, etc.)
  • Quality control of raw materials, intermediates, and APIs
  • Impurity evaluation and analysis
  • Sequence analysis
  • Others
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