Reliable, high-quality manufacturing of complex small molecules and advanced modality components — from gram-scale to multi-hundred gram batches with full documentation.
Comprehensive contract manufacturing capabilities for small molecules, intermediates, and advanced modality components.
Bespoke manufacturing of complex molecules, advanced intermediates, and reference standards at defined quality specifications.
Manufacturing executed under GMP-aligned procedures with full documentation to support clinical and regulatory submissions.
Execution of extended linear and convergent synthesis routes at manufacturing scale, including handling of reactive intermediates.
Comprehensive in-process and final product testing against validated specifications, with full analytical documentation.
Complete executed batch records with all in-process data, environmental monitoring, and analytical results.
Specialized manufacturing of PROTAC intermediates, ADC components, peptide building blocks, and macrocycle precursors.
Our quality management approach ensures that every batch meets the specifications your program demands, with the documentation to support regulatory review.
GMP manufacturing aligned with ICH Q7 guidelines for active pharmaceutical ingredient manufacture.
All release testing performed using validated methods with documented validation reports.
Full traceability of raw materials, intermediates, and final product with complete audit trails.
Batch records, CoAs, and process documentation structured to support IND/CTA and NDA/MAA submissions.
From first batch to clinical supply, Astinova's manufacturing team delivers quality and consistency you can rely on.
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