KriSan Biotech Co., Ltd. offers the services for process and analytical development as well as the manufacturing of the intermediates and Active Pharmaceutical Ingredients (API) for pre-clinical and clinical stages. With the extensive experiences and CGMP facilities, we are proud to provide the following services:
- Process R&D and analytical services for small molecules, peptides and PDCs (peptide drug conjugate)
- 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 CMC activities
Process Research and 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 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
The team members of Analytical Technology Service (ATS) at KriSan Biotech Co., Ltd. have extensive experiences in pharmaceutical analytical research and development. ATS provides full analytical services for process development, GLP studies and CGMP manufacturing. In general, the services include but not limited to, method development, method verification/ validation, reference standard qualification, release testing, and impurity separation and identification.
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.:
KriSan Biotech Co., Ltd. offers regulatory support from early stage drug substance development to commercial API manufacturing, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Drug Master Files (DMF).
- Regulatory and strategic consultation for new drugs at early development stage
- Compilation of registration materials, including CMC, pharmacological and toxicological data and clinical research protocol
- Preparation and submission of registration documentation