What is PilotDx oligo manufacturing?

PilotDx™ oligos are ideal for the design optimisation and verification stages of product development. Reduced documentation overhead lets you minimise cost and turnaround time while maintaining continuity with the full GMP process required during the validation and commercialization stages of your product.

Our contract manufacturing group produces PilotDx oligos using the same equipment, processes, and personnel used for GMP oligos. We ensure quality by maintaining hard copy batch reports and a review of analytical data by Quality Control.

Beneficial features

  • Cheaper and faster alternative to GMP-grade oligos
  • Ideal for product development and pilot testing
  • Continuity with GMP processes eases the transition to commercial production
  • Accompanied by Certificates of Analysis released by Quality Control

PilotDx oligo manufacturing service

Product/service Custom oligos for product design verification (e.g. test method validation, performance qualification , stability studies, etc.)
Customer emphasis Price, turnaround time, continuity with GMP processes
Quality system ISO 13485:2003 certified internal quality system
Manufacturing scalability Hundreds of compounds, 100’s-1000’s nmol delivered
Equipment Validated (IOQ); PM’s and calibration
Quality control Customizable Mass Spectrometry and analytical HPLC specs
Product approval Released by QC pending results; batch report retained by QA
Documents provided Standard C of A, MS & HPLC Traces
Formulations and packaging Typically delivered dry in tubes
Documentation and tracking Sequences tracked in database; product info form; batch report
Price Competitive pricing due to vertical integration; minimal documentation costs
Turnaround time 2-4 weeks

 

Have any questions?  Request a free consultation session.