Comprehensive manufacturing services

Our services include everything needed to take your program from preclinical research to clinical trials and finally to commercialization

Comprehensive Manufacturing Services

Our full-service cGMP plasmid manufacturing services include:

  • Highly trained process development scientists and manufacturing engineers
  • Inbound technology transfer and seamless scale-up
  • Robust process optimization to achieve desired critical quality attributes while maximizing yield
  • Manufacturing in segregated, validated clean rooms with 24/7 monitoring
  • Defined and validated critical process parameters (temperatures, times, agitation rates, etc.)
  • Full-scale engineering and process validation capabilities to enable cGMP production
  • Procurement and management of cGMP-grade materials sourced from audited and qualified suppliers
  • Client-specific batch record and documentation with Certificate of Analysis upon full quality release
  • Generation, characterization, and storage of master and working cell banks
  • Full suite of analytical testing capabilities, including assay qualification and validation

An Akron specialist will be in touch with you within 24 hours

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