CRO/CDMO Services

KriSan Biotech Co., Ltd. offers the contract services for synthetically research, process and analysis development as well as the manufacturing of the intermediates and Active Pharmaceutical Ingredients (API) for drug substances in pre-clinical/clinical stages, commercial manufacturing and strategic generic API development. With the extensive experiences and cGMP facilities, we can confidently provide the following services:

  • Process R&D and analytical services for small molecules, peptides, PDCs (peptide drug conjugate), oligonucleotide and complex drug substances
  • Process scale-up and validation
  • Analytical method development and validation
  • Manufacturing from grams to kilograms’ scale for intermediates and APIs
  • Stability test in compliance with ICH
  • All application documents relating to CMC of IND, NDA, ANDA

Research and Process Development

Process development and synthetic route optimization are core competencies at KriSan Biotech Co. Ltd.: providing services to customers who seeking to improve troublesome steps in a process, reduce the cost of goods by removing expensive or poorly performing steps, or re-design an entire route for one of their potential products or key intermediates.

The team members of Process Technology Service (PTS) at KriSan Biotech have extensive experiences in pharmaceutical process research and development for small molecules and peptides. This process research and development team works closely with the Analytical Technology Services (ATS) team to integrate the chemistry and analytical controls, into the process at an early stage of development cycle.

All the process research works are documented into a process development report that outlines the chemistry and synthetic approaches that were tried as part of the synthetic development effort. This report also includes a detailed experimental with supporting analytical data for the successful chemistry that results from the developed effort. Coupled with the analytical and CGMP capabilities, KriSan Biotech provides the essential groundwork for any potential compound that enters preclinical use to clinical trials.

We offer the following services:

  • Evaluate the existing synthetic route and identify the steps that may cause problems during scale-up manufacturing
  • Process improvement based on the concept of Quality by Design (QbD)
  • Ensure the synthesis is suitable for long term and large scale manufacturing
  • Search for reliable suppliers for key starting and raw materials
  • Capable to produce few grams to kilogram scale of intermediate and API in laboratory for drug discovery or pre-clinical use
  • Prepare API, intermediate and impurity reference standards
  • CGMP sample preparation for pre-clinical and clinical trials from hundred grams to kilogram scale

We also provide the services for process optimization.

  • Overall yield improvement
  • Reduction in the number of steps and/or operation
  • Reduction in process volume
  • Elimination of chromatography
  • Ease of scalability
  • Safe and robust processes
  • Mitigation of negative environmental impacts
  • Cost optimization

Analytical Services

The team members of Analytical Technology Service (ATS) at KriSan Biotech Co., Ltd. have extensive experiences in analytical research, in-process control, method development and product quality control. ATS provides full analytical services for method development, qualification, validation, reference standard qualification and characterization. Analytical reports or COA   releasing testing for material, intermediate, product in cGMP manufacturing and stability program in compliance with current regulations are reviewed, issued and preserved.

We offer the following services:

  • Analytical method development and validation for raw materials, intermediates, and APIs
  • Compound identification and characterization including API, impurities, degradants and etc.
  • Reference standard qualification
  • Establish specification for raw materials, intermediates, and APIs as well as release testing
  • Stability studies for bulk active ingredients and preparation of regulatory documentation, including chemistry manufacturing and control sections of investigational new drug applications

Analytical Instrument at KriSan Biotech Co., Ltd.:

Chemical Property Determination
  • HPLC  / UPLC
    • UV
    • PDA
    • Refractive Index
    • Fluorescence
  •  GC / Headspace GC
  • Auto-titration
  • Total Organic Carbon
Physical Property / Spectroscopic Analysis
  • DSC
  • TGA
  • Polarimeter
  • Particle Size Analyzer
  • Karl Fischer
    • Volumetric
    • Coulometric
    • Thermoprep (oven)
  • Melting Point
  • FT-IR
  • UV-Vis
  • ICP-MS / Microwave digestion
  • Vacuum Oven
  • Conductivity Meter
Stability Study
  • Stability Chamber
    • -20 °C
    • 5 °C
    • 25°C / 60%RH
    • 30°C / 65%RH
    • 40°C / 75%RH
  • Suntest (photostability testing)

Regulatory Services

KriSan Biotech Co., Ltd. offers regulatory support from early stage drug substance development to commercial API manufacturing, including Investigational New Drug Applications (IND), New Drug Applications (NDA), Abbreviated New Drug Application (ANDA) and Drug Master Files (DMF).

  • Regulatory consultation for new drug pre-clinical clinical, commercial and/or generic
    • Including small molecules, peptides, PDCs (peptide drug conjugate) and oligonucleotide
    • Evaluation of registration requirements. e.g. IND (Phase 1, Phase 2, Phase 3)
    • Drug substance related guidance and regulation
  • Preparation and maintenance of registration documents (Taiwan, US…)
    • CMC compiling
    • DMF preparation and maintenance
    • Preparation of registration dossier in eCTD format
  • Communication with authorities
    • Help customers to consult authorities (TFDA, FDA…) about regulatory issues