Process Development /

Drug Product Development

Drug product development

Drug product formulation development activities cover both drug substance and finished drug product development. Drug substance is packed into vials and drug product is either in lyophilized form or in solution, vials or prefilled syringes. Stability studies are performed according to ICH guidelines and are supported by Biotechpharma QC with all necessary stability-indicating methods. Main activities performed:

  • Scouting by stress and accelerated stability studies
  • Estimation of product’s shelf-life by long-term stability programs
  • Development of drug product formulation for Fill & Finish at a pilot scale
  • Development of specifications for both DS and DP