Rapid Synthetic Development

You are in good hands with BPL’s world-class chemists, who are able to rapidly develop novel route synthesis and process optimization with the key attributes of lower unit reactions, cost and waste.  Furthermore, once the bench route is completed … manufacturing cGMP API production starts.  Once our development is complete … it is COMPLETE … meaning that once the route is demonstrated on the bench it is ready to directly go into API scaled manufacturing.  Initial development scales through commercialization without re-engineering.  Our capabilities include chemical process R&D via Ai and ML enabled continuous flow including development of manufacturing processes for non-GMP and GMP intermediates and clinical-stage APIs.

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Working in state-of-the-art laboratories equipped with our proprietary AI and ML enabled continuous flow reactors and integrated analytical instrumentation, we efficiently conduct route scouting, rapid process development, optimization of reaction conditions for scale-up of materials for pre-clinical trials or cGMP commercial manufacturing.

With support from our expert team of analysts, chemists, chemical engineers and QA professionals, we rapidly and efficiently develop scalable manufacturing processes to meet any need, including development of high-potency APIs and DEA-licensed controlled substances.

Our capabilities include:

  • Custom synthesis
  • Translation of batch chemistries into continuous flow
  • Process safety assessment
  • Rapid scale-up capabilities for GMP and non-GMP purposes
  • Route evaluation and development of novel synthetic routes for target molecules
  • Optimization of reaction conditions to reduce cost and maximize throughput by classical methods or statistical design of experiments
  • Development of reliable methods for in-process testing and analysis of intermediates and APIs
  • Development of robust crystallization procedures for intermediates and final products
  • Salt selection and polymorph screening
  • Preparation of APIs for non-clinical safety studies under GLP conditions
  • Rapid screening of reaction conditions using parallel equipment
  • Critical process parameter assessment
  • Development of continuous flow manufacturing processes