CMC Solution Services
We provide “CMC solution service” (Sample synthesis, Analytical test, Development of
synthetic procedure, Development of analytical procedure, and CMC developmental
support) as One-Stop Service at all Research and Developmental stages.
Development of Synthetic Procedure
We meet the various customer's needs by offering the service of “API process development and Quality design” based on our experiences and know-how accumulated in contract manufacturing for API or intermediates so far. Experts of the process development provide CMC solution services seamlessly and speedily from synthetic procedure studies including synthetic route scouting to API manufacturing.
- Synthetic route scouting for API and intermediates (Major pharmaceutical company)
- The drastic improvement of API manufacturing process (Major pharmaceutical company, Bio-venture)
- Sample synthesis for API or intermediates
- Synthetic procedure studies, Synthetic route scouting
- Synthetic route selection (SELECT criteria)
- Synthesis and identification for impurities, metabolites, decomposition product, standard reference material, etc.
Development of Analytical Procedure
Experts of CMC development meet the various supports of customer’s quality issues at every stage of drug development. We can develop analytical methods that can evaluate the quality of drug substance. Thanks to our internal close relationship, collaboration and communication among R&D and manufacturing members we can surely grasp impurity management strategies of drug substance and intermediate. Furthermore, we can conduct various analytical tests based on both quality standards of GMP and regulations for quality.
- Development of test procedure of related substances (Major Pharmaceutical company)
- Development of analytical methods of API for clinical trial (Bio-venture)
- Setting of test procedures and acceptance criteria（Bio-venture）
- Analytical method scouting
- Development of physical and chemical examinations and general tests, biological tests and microbial tests, and evaluation of physical properties
- Development of high-sensitivity analytical method (Ex. ICH M7)
- Development of elemental impurities analytical method using ICP-MS (Ex. ICH Q3D)
- Analytical method validation
- Setting of test procedures and acceptance criteria
- Quality test and quality evaluation of API and related compounds
- Stability test
CMC Developmental Supports
Experts of CMC development meet the various customer's needs from early development stage to new drug application. We provide long-term process management strategy (various regulation correspondence, construction of the supply chain, new drug application, commercial manufacturing) through the whole drug life cycle as "One-Stop" service by fully utilizing our production facilities.
- Process parameter studies for application using the PAT equipment (Major pharmaceutical company)
- CMC development appropriate to each drug development stage
- CMC development using the PAT (Process Analytical Technology) equipment
- Quality by design (QbD), risk assessment (FMEA), design of experiments (DoE), development of design space (DS) and control strategy
- Preparation and documentation for IND, NDA and Drug Master File, official inquiry correspondence
- CMC developmental supports by outsourcing (e.g. polymorph screening, in silico screening (ICH M7), synthesis of radio-labeled compounds, MSDS authoring service, CMC consulting, intellectual property investigations, etc.), and project management
- Management of raw material pharmaceutical suppliers compatible with PIC/S GMP and construction of the supply chain