Production Process Optimization

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Service we provide

• Medicilon’s API production process optimization services include:
  Establishment of API quality standardsEstablishment of central control standardOptimization and determination of important process parametersOptimization and determination of post-processing methodOptimization and determination of purification methodEvaluation and control of process risksProcess safety evaluationAutomatic reaction calorimeter RC1mx, differential scanning calorimeter (DSC) and accelerating rate calorimeter (ARC) to evaluate reaction calorimetry, secondary reactions of raw materials, intermediates, and products (thermal stability evaluation) Establishment of quality standards for raw materials, intermediates, and finished productsImpurity profile researchPreparation of CTD documents

Service Cases

FAQs

• To What Extent does Process Optimization Need to be Done?

  It needs to meet the quality requirements of laboratory scale, safety, pilot, and clinical batches, with appropriate attention to yield and process fluency.

• What is Process Development Stage?

  1. Literature research, patent evaluation report.

  (1) Gather as much relevant publicly available information as possible.    
  (2) Design multiple possible synthesis routes.    
  (3) Evaluate potential intellectual property risks associated with each synthesis route.

  2. Select a synthesis route and design reactions

  (1) Finalize the design of each reaction step, evaluating profiles, impurity spectra, yield, and quality based on accumulated knowledge.
  (2) Finalize post-treatment designs, including quenching, purification, filtration, and drying.
  (3) RFT (Right First Time).

  3. Process optimization.

  (1) Compare pre- and post-optimization results, identifying "key process points.""   
  (2) Drafting of preliminary quality standards for starting materials and intermediates.

  4. Impurity spectrum study.

  (1) A comprehensive study is not required.   
  (2) There should be an overview of the major impurities.

  5. Analysis of the reaction mechanisms.

  (1) Analyze the reaction mechanism of each step to control side reactions.  
  (2) Optimize conditions favoring primary reaction.

• What are Process Research Methods?

  • DOE and Parallel reaction 

  Optimization of reaction conditions: reagent equivalent, temperature, concentration, reaction time, etc. 

  These methods can significantly improve the efficiency of condition optimization and quickly achieve optimal conditions.

  • Destructive test (Stress test) 

  It is essential to do destructive tests for laboratory-scale batches, including the stability of starting materials, intermediates and products. 

  After the initial optimization of the process, it tests the applicable scope of the process.

  • The Spiking experiments 

  Verification of process performance, such as assessing the reasonableness of specification settings and the capability to remove impurities.

Relevant laboratories

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