Background: A big pharmaceutical company approached Aurigene Pharmaceutical Services for manufacturing an activated mPEG derivative. The process involved 11 stages. Three major chain stages and eight intermediate steps.Challenges:Stage-1 and 2 reactions are sluggish and observed unreacted starting materials which is difficult to purify. Only 10-20% product formation observed in stage-3. Stage-3 product was unstable under reaction conditions and during isolation. The key intermediate is not commercially available and involves complex chemistry.
Aurigene solution:Optimized the mole equivalents of reagents in all stages to drive the reaction for completion, which helped to avoid carryover of impurities to final stage. Screened multiple bases/solvents/temperature for stage 3 and ensured the completion of reaction. Identified suitable isolation and storage conditions (-20°C) to avoid the stage-3 product degradation. Optimized the final stage reaction & purification process to achieve>90% purity.Appropriate optimization of the parameters helped in successful scale up of side chain (key intermediate).Outcome:Successfully manufactured an activated mPEG derivative in several campaigns.
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