Small Molecule Preparation CDMO Service

Small Molecule Preparation CDMO Service

Protheragen-ING Lab provides comprehensive small molecule preparation contract development and manufacturing services (CDMO) services. We are committed to providing our clients with one-stop small molecule preparation development and manufacturing solutions, from early-stage R&D to commercialization, to meet your needs. We have the experience and advanced technology to help your small molecule drug program move forward smoothly.

Overview of our CDMO services

Our CDMO services cover the entire life cycle of small molecule drugs from concept to market. Our state-of-the-art facilities and specialized teams ensure an efficient and compliant development and manufacturing process. Below are the key services we provide:

Drug Discovery

  • Drug Discovery and Design: We help our clients discover and optimize new drug candidate molecules through technologies such as computer-aided drug design (CADD), high-throughput screening (HTS), and structural biology.
  • Synthetic Chemistry: Provides organic synthesis services from milligram to kilogram scale to ensure the supply of high-quality compounds.
  • Medicinal Chemistry and Analysis: Performs compound characterization, purity analysis, and stability studies to ensure the quality and consistency of drug candidates.

Formulation Development

Solid preparations Develop tablets, capsules, and other solid oral preparations.
Liquid preparations Develop liquid preparations such as injections and oral liquids.
Delayed and controlled release formulations Develop formulations that control the release rate of drugs to improve efficacy and reduce side effects.

Process Development and Optimization

  • Process Chemistry: Develop and optimize chemical processes suitable for large-scale production to ensure reproducibility and efficiency of reaction conditions.
  • Process Safety Assessment: Ensure process safety and controllability through reaction safety studies.
  • Scale-up Production: Ensure a smooth transition at each stage, from laboratory scale-up to pilot production to commercial production.

Analytical & Quality Control

  • Method Development and Validation: Develop and validate analytical methods applicable to quality control to ensure product consistency and traceability.
  • Stability Studies: Conduct stability studies in accordance with ICH guidelines to assess the long-term stability of the drug.
  • Quality Management: Strictly implement a comprehensive quality management system to ensure product quality reliability.

Commercial Production

  • Scale-up Production: Realize technology transfer from small pilot to pilot and then to large-scale production.
  • Supply Chain Management: Provide supply chain management services for APIs and formulations.

Our Technology Platform

Synthesis Technology High-throughput synthesis: rapid screening and optimization of synthetic pathways.
Enzyme-catalyzed synthesis: using biocatalytic technology to improve reaction selectivity and efficiency.
Formulation Technology Nanotechnology: Utilize nanotechnology to improve drug solubility and bioavailability.
Liposome technology: develop liposome-encapsulated drug formulations to improve drug stability and efficacy.
Analytical Technology HPLC/UPLC: High-performance liquid chromatography (HPLC) technology is used for purity and impurity analysis of compounds.
LC-MS/MS: Liquid-mass spectrometry technology for quantitative analysis of complex samples.

Protheragen-ING Lab has successfully helped a number of clients advance their small molecule drugs from the R&D stage to the market, covering a wide range of therapeutic areas, such as anti-tumor, anti-infective, and cardiovascular diseases. Our excellence in project management, technical support, and customer service has earned us widespread recognition and trust.

If you are interested in our services or would like more information, please feel free to contact us. We look forward to working with you to promote the innovation and development of small molecule drugs.