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PROJECT A

Characteristics

  • Cytotoxic API 
  • Organic molecule, 11 steps
  • Parenteral, manufacturing in a clean room environment under microbiological control
  • Batchsize: 500 g
  • Quantity: 10 kg / year

Main challenges

1) Step 10: yield lower than 15%. Cause: Exothermic quenching of an aluminum hydrate, while reduction product is very heat sensitive. Product degraded and impurities were formed which could not economically be reduced below 0.1% in final product. Rigorous cooling even at -78°C was ineffective.

2) Product is cytotoxic and manufactured by using a highly mutagenic and toxic reagent with a low boiling and flame point.

Solutions

1) A continuous flow process by use of microreactors was developed. Yield increased to 75% and none of the undesired impurities were detected in final product.

2) A closed apparatus to react the reagent with the intermediate was developed and installed in a custom made isolator, and qualified for GMP.

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PROJECT B

Characteristics

  • Organic molecule, 4 steps
  • API against a special form of sclerosis
  • Parenteral, manufacturing in a cleanroom environment under microbiological control
  • Batchsize: 10 kg
  • Quantity: 100 kg / year, expected to increase to 500 kg / year

Main challenges

1) The only known process on a technical scale yielded material of less than 85 % purity. Thus a novel cGMP-compliant synthetic route had to be developed. The timeline was extremely tight, because investors demanded first studies on patients to be started within 8 months.

2) The compound had a waxy appearance. Purification was not possible by standard methods.

3) Analytics of final product.

Solutions

1) A scalable cGMP process could be developed and performed within a timeline of 6 months.

2) A liquid/liquid rotary extraction process could be developed, purity larger 99.9 %.

3) A method using an ELSD detector showed to be successful. This new detection technique was implemented and the method validated at ChemCon within 4 months.

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PROJECT C

Characteristics

  • Inorganic compound, 2 steps
  • Cytotoxic API
  • Parenteral, manufacturing in a cleanroom environment under microbiological control
  • Batchsize: 1,000 g
  • Quantity: 10 kg / year

Main challenges

1) High temperature process, impracticable for large scale, needed complete redesign

2) Milling under high containment

Solutions

1) Novel high temperature reaction equipment was developed and qualified under GMP

2) Milling was established in a custom-built isolator

The process could be established in short time, fastest NDA aproval in FDA history.

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