Services offered by Chesilton LLC

1).  Assessment of the scalability of GMP active pharmaceutical ingredient (API) and fine chemical synthesis into pilot or production sized equipment.  Chesilton will provide technical assistance in route selection, equipment selection, preparation of manufacturing instructions, as well as raw material sourcing and selection. 

2). Expert thermal analysis of reactive chemistry.  Laboratory work including reaction calorimetry, accelerating rate calorimetry and differential scanning calorimetry.

2). Selection, suitability assessment, and qualification of outsource vendors for GMP API, fine chemical and pharmaceutical intermediate manufacture.

3).  Recommendation of the experimental program necessary to develop the scale-up plan from a process safety and operability perspective.  This includes the recommendation of the work necessary to perform material and energy balances, yield and throughput predictions, thermal stability assessments, kinetic analyses.  Chesilton can assess what technical data is required to assess the process hazards of reactive chemistry, and contract those if required.

4).  Assistance in the planning, documentation, and execution of the qualification of GMP active pharmaceutical ingredient manufacturing facilities.  This includes preparation and review of Installation and Operational qualification (IQ/OQ), authorship and review of Standard Operating Procedures (SOPs), equipment calibration procedures, change control procedures and deviation investigation procedures.

5).  Training of laboratory, engineering and operating staff on the scale-up and manufacture of GMP active pharmaceutical ingredients.

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