Services

CMC experts from Japanese leading pharmaceutical company

CMC experts from Japanese leading pharmaceutical company provide CMC solutions from early-stage through new drug application
By cooperation of SPERA and Bushu Pharmaceuticals, we provide CMC solutions, globally at a high level, meeting customer needs on all stages R&D through commercial production.

  • API process R&D and the manufacturing with adequate quality in each development stage via an unique supply chain management
  • Formulation development, packaging design and GMP clinical trial material (CTM) manufacturing which meets specifications
  • Analytical method development and quality evaluation meeting demands on each development stage from early stage through NDA
  • High capability of quality management and handling audits by authorities
  • Cope with overseas development and registration works
  • Project management, which enables one-stop service, by building and managing networks with alliance partner

Process Chemistry

  • API process development appropriate to each development stage and use (Establishment of process control strategy)
  • API supply through optimal and flexible supply chain
  • Strategic planning and documentation for new drug application, and handling audits by authorities
  • Acceleration of first IND and development till POC (Proof of Concept)
  • API cost reduction compatible both regulatory handling and economic efficiency in each development stage

Formulation

  • Formulation development of small molecules and biologics
  • Packaging design
  • Regulatory filing (IND/NDA application)
  • GMP manufacturing of CTM (handling global audits)
  • Commercialization research (tech transfer, scale-up, collaboration with Bushu)

Analysis

  • Structural elucidation of impurities
  • Physicochemical-related test: General test and physical evaluation, such as related substances and BE dissolution test
  • Microbial-related test: Microbial limits, sterility test, endotoxin, and environment bacteria identification
  • Documentation for IND and new drug application, and handling audits by authorities
  • Tech transfer of analytical methods (Process, drug substance, drug product)
  • CTM release test, stability test, and registration stability test
  • Development of high-sensitivity analytical methods for potential genotoxic substances, etc.

SPERA provides CMC solutions from early-stage through new drug application